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Unread 08-31-2010, 08:53 AM   #1
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Exclamation •• UPDATE 9/30/2011••$45 OFF••FDA approves •Suboxone Film

FDA approves Suboxone Film 8/31/2010 (updated 9/30/2011)

UPDATE: 9/30/2011 copay card extended through March 2012

Today the FDA announced approval of Suboxone® Film. It is somewhat similar to the Listerine® breath strips, except that it is placed on the bottom of the tongue where it is absorbed into the bloodstream. It’s an improvement over the tablets in that, it dissolves faster than the tablet, it’s rumored to taste better, and it comes in single-dose child resistant individually sealed waterproof packets. Although it dissolves faster, it still has equivalent bioavailability as the tablet and will come in the same 2mgs and 8mgs doses. There is no Subutex® film.

edited 9/30/2011
PRINT OUT A $45/MONTH SAVINGS CARD HERE



News Article

Suboxone Film Prescribing Information

Availability alert - discount details

Photo of demonstration film (added 9/20/2010)

The cost of the Film will be the same as the current cost of the tablets. Plus, the manufacturer will be offering a discount program for all film prescriptions that applies up to $45 [edited 9/30/2011] toward the patients’ out of pocket cost of the prescription for the first few months. (Through March 2012) Patients will go online and print out a discount card to bring to the pharmacy. (Prohibited by law in Massachusetts.)

(added 9/29/2010)
New info about Suboxone Film:
http://suboxone.com/pdfs/503353_M04_...ct%20Sheet.pdf

Video by the manufacturer on how to take the film (first 1 minute 45 seconds- the rest is fair balance)
http://suboxone.com/patients/about_s...XONE_film.aspx


(added 11/10/2010)
Photo of Suboxone film
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Unread 08-31-2010, 09:09 AM   #2
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Default Official Press Release

Aug 31, 2010 (PR Newswire Europe via COMTEX) --Reckitt Benckiser Group plc

Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Approval for Suboxone(R)

(Buprenorphine and Naloxone) Sublingual Film C-III

Richmond, VA (31st August 2010) - Reckitt Benckiser Pharmaceuticals Inc. today announces that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) to manufacture and market Suboxone(R) sublingual film. Suboxone(R) sublingual film has been developed through an exclusive agreement with MonoSol Rx, utilising its proprietary PharmFilm(R) technology, to deliver the opioid dependence treatment Suboxone(R) in a fast-dissolving sublingual film.


Suboxone(R) sublingual film is indicated for maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counselling and psychosocial support. Prescription use of this product is limited to physicians certified under the Drug Addiction Treatment Act, 2000.

Suboxone(R) sublingual film will be available from early October 2010 to patients in the same doses as currently offered by Suboxone(R) (buprenorphine and naloxone) sublingual tablets C-III. A Risk Evaluation and Mitigation Strategy (REMS) program is being implemented as part of the FDA requirements to ensure that the benefits of treatment with Suboxone(R) sublingual film outweigh the potential risks, particularly risks of accidental overdose, misuse and abuse.

Commenting on the FDA's approval, Shaun Thaxter, President of Reckitt Benckiser Pharmaceuticals Inc. said: "The development of Suboxone(R) sublingual film through our exclusive agreement with MonoSol Rx reinforces our commitment to our opioid dependence therapy franchise and to its development. During clinical studies, Suboxone(R) sublingual film was shown to be faster dissolving than Suboxone(R) sublingual tablets. Because of the faster dissolution and the taste profile, patients preferred the film. Each individual dose of Suboxone(R) sublingual film will come in a child-resistant pouch.

Our partnership with MonoSol Rx represents a strategic business opportunity which will contribute to the longevity of Suboxone(R) in the U.S."

About Reckitt Benckiser Pharmaceuticals Inc.

Reckitt Benckiser Pharmaceuticals Inc. is a speciality pharmaceutical company that manufactures and markets Suboxone(R) (buprenorphine and naloxone [2 mg/0.5 mg and 8 mg/2 mg]) C-III sublingual tablets and Subutex(R) (buprenorphine [2 mg and 8 mg]) C-III sublingual tablets, formulations of buprenorphine used to treat opioid dependence. Reckitt Benckiser Pharmaceuticals Inc. is committed to expanding access to medical therapies for patients suffering from the chronic, relapsing brain disease of opioid dependence. For more information, visit suboxone.com or heretohelp.com. Reckitt Benckiser Pharmaceuticals Inc. is a wholly-owned subsidiary of Reckitt Benckiser Group plc, a global company publicly traded on the UK stock exchange.

About MonoSol Rx, LLC

MonoSol Rx, LLC is a speciality pharmaceutical company leveraging its proprietary PharmFilm(R) technology to deliver drugs in quick dissolving films.

PharmFilm(R) is designed to benefit patients by improving the convenience, efficacy, and compliance of new and currently marketed drugs. The Company's leadership in thin film drug delivery is supported by strong intellectual property, a portfolio of commercialised over-the-counter (OTC) drug products, and a development pipeline of prescription formulations based on PharmFilm(R) technology. With a vertically integrated development and production infrastructure, MonoSol Rx, LLC has the capacity to manufacture OTC drug products for near-term revenues that fund prescription product development programmes that will generate long-term value.

The Company's commercialisation strategy for all PharmFilm(R) products is to partner with the innovator, other speciality pharma or leading consumer products companies that can sell-in and manage product sales and marketing. For existing and future partners, PharmFilm(R) formulations represent revenue life-cycle extensions for products with patent lives that have expired or are approaching expiration. PharmFilm(R) is a tool to help sales and marketing partners differentiate in competitive markets while offering unique advantages over drugs dosed by traditional tablets, capsules and orally disintegrating tablets (ODTs).

Important Safety Information

Suboxone(R) (buprenorphine and naloxone) sublingual film (C-III) is indicated for maintenance treatment of opioid dependence as part of a complete treatment plan to include counselling and psychosocial support. Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

Suboxone(R) sublingual film should not be used by patients hypersensitive to buprenorphine or naloxone.

Suboxone(R) sublingual film can be abused in a manner to other opioids, legal or illicit. Clinical monitoring appropriate to the patient's level of stability is essential.

Chronic use of buprenorphine can cause physical dependence. A sudden or rapid decrease in dose may result in an opioid withdrawal syndrome that is typically milder than seen with full agonists and may be delayed in onset.

Suboxone(R) sublingual film can cause serious life-threatening respiratory depression and death particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other central nervous system (CNS) depressants (ie, sedatives, tranquilisers, or alcohol). It is extremely dangerous to self-administer nonprescribed benzodiazepines or other CNS depressants while taking Suboxone(R) sublingual film. Dose reduction of CNS depressants, Suboxone(R) sublingual film, or both when both are being taken should be considered.

Liver function should be monitored before and during treatment.

Death has been reported in nontolerant, nondependent individuals, especially in the presence of CNS depressants.

Children who take Suboxone(R) sublingual film can have severe, possibly fatal, respiratory depression. Emergency medical care is critical. Keep Suboxone(R) sublingual film out of the sight and reach of children.

Intravenous misuse or taking Suboxone(R) sublingual film before the effects of full-agonist opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided is highly likely to cause opioid withdrawal symptoms.

Neonatal withdrawal has been reported. Use in pregnant women or during breast-feeding should be only if the potential benefit justifies the potential risk. Caution should be exercised when driving vehicles or operating hazardous machinery, especially during dose adjustment.

Adverse events commonly observed with the sublingual administration of Suboxone (R) sublingual film are numb mouth, sore tongue, redness of the mouth, headache, nausea, vomiting, sweating, constipation, signs and symptoms of withdrawal, insomnia, pain, swelling of the limbs, disturbance of attention, palpitations and blurred vision.

Cytolytic hepatitis, jaundice, and allergic reactions, including anaphylactic shock, have been reported.

This is not a complete list of potential adverse events associated with Suboxone(R) sublingual film. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking Suboxone(R) sublingual film, please call 1-877-782-6966. You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For further information, please contact:
Reckitt Benckiser Group plc +44 (0)1753 217800
Joanna Speed
Director, Investor Relations

Andraea Dawson-Shepherd
SVP, Global Corporate Communications and Affairs
Reckitt Benckiser Pharmaceuticals Inc.

Harriet Ullman +1 617 761 6776
Feinstein Kean Healthcare

END
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Unread 08-31-2010, 03:05 PM   #3
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How cool is that?? Damn, wish they had that around when I was on sub. Oh well. Wonder if you can cut the strips down to make it easier tapering.

Very cool about the discount too.

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Unread 08-31-2010, 07:54 PM   #4
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Any idea what they will cost. I know they have to get their money back from all the research but really now I can buy Listerine breath strips for a few bucks. Just change out the ingredients for the Listerine with suboxone. The technology for the strip has already been invented. It can't cost that much to just change ingredients. Since this is the internet and you can't see sarcasm I will say, I am kidding, well partially kidding.

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Unread 09-01-2010, 12:15 PM   #5
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I think it will cost the same as the tablets. Unlike with breath strips, it costs millions to get an FDA approval and millions more to adhere to all of the regulations, not to mention all that was invested in the drugs and research that didn't make it to the FDA.
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Unread 09-01-2010, 01:30 PM   #6
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Thanks Tim, that's what I thought. I thought maybe they would add a few dollars to the price since it was a new product.

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Unread 09-01-2010, 02:50 PM   #7
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Hi Darrin, I was afraid of that too, since it must cost more to produce than the tabs do. Actually, there will be a discount available at first making it less expensive than the tabs at least for a while. I'll post links to more about that when available.
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Unread 09-01-2010, 04:24 PM   #8
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I wonder what insurance companies will cover it, especially medcaid. This could really cut down on abuse since so many people here sort the pills. I don't think you can sort a strip but who knows someone will find some way to abuse them, I am sure.
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Unread 09-01-2010, 04:42 PM   #9
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It should definitely help, but abuse isn’t a big problem with the tabs, it’s the accidental child exposure that’s more of a concern. In one survey of patients who said they have bought diverted bupe at some time, 90% said they used it as directed and cited price or access as the reason it was obtained illegally. The few that do abuse it soon realize that it’s a poor choice for someone intent on misuse, and switch back to cheaper and stronger full agonists. Some also find that the risk of snorting isn’t worth it either, as the cornstarch binders can get lodged in the sinus cavity and become a food source for fungus. Sometimes it gets infected and has to be removed with surgery…the sinuses are behind the face.

I think insurers would be more likely to cover it, hopefully Medicaid will be on board.?!?
Tim
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Unread 09-02-2010, 04:59 PM   #10
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Quote:
Originally Posted by TIM View Post
It should definitely help, but abuse isnÂ’t a big problem with the tabs, itÂ’s the accidental child exposure thatÂ’s more of a concern. In one survey of patients who said they have bought diverted bupe at some time, 90% said they used it as directed and cited price or access as the reason it was obtained illegally. The few that do abuse it soon realize that itÂ’s a poor choice for someone intent on misuse, and switch back to cheaper and stronger full agonists. Some also find that the risk of snorting isnÂ’t worth it either, as the cornstarch binders can get lodged in the sinus cavity and become a food source for fungus. Sometimes it gets infected and has to be removed with surgeryÂ…the sinuses are behind the face.

I think insurers would be more likely to cover it, hopefully Medicaid will be on board.?!?
Tim
I hate to say it but here, bupe seems to be very abused- most people I have come across who take it without or with prescription are in fact snorting or injecting it. This is purely anecdotal based on my observation from my employment.
Every person, probably 100 over the past 4 years that I have interviewed either have abused or currently abuses it or "knows" someone who does or has.
The thing I never can understand is why the narcan doesn't has the precipitated withdrawal for the ones I have spoken to who have injected it on an ongoing bases. And this is Suboxone, not Subutex. Why doesn't it happen to them? I mean, yes some of these people have had to go to the ER for abscesses and infection. . .but it's as if the naloxone doesn't seem to block the buprenorphine.
My SO tried to explain to me that basically it's like reaching your hand into a car and trying to find one lever of many levers and bottoms and assorted things. The molecule bounces around until it finds the receptor and because everyone's receptors are different, the molecule can't find the "lever" or they don't have as many receptors as other people. . .but then I wonder, well if this type of person can inject suboxone and get high, then if they OD'ed on a full agonist and went to the hospital, then would they not be saved by narcan since the usual dosage is 2 mg, which is what is in Suboxone anyway.
Do you know of any studies done on the population of people who seem to get high from injection of Suboxone? I really want to know chemically how this is possibly since Naloxone was added as an IV abuse deterrent.
One more thing I really want to know is why some people report not feeling any effect of full agonist opiates with a moderate dose of buprenorphine yet others report the buprenorphine has no blocking affect.
Also, as far as cost, buprenorphine is only 10 dollars for an 8 mg pill here, where as all opiates are a dollar a mg. So buprenorphine lasts longer and the the cost is way lower per day. However, where I live, opiates are not easy to come by and are double and triple the price found virtually everywhere else.
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Unread 09-02-2010, 05:35 PM   #11
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Quote:
Originally Posted by ohmygoddess View Post
I hate to say it but here, bupe seems to be very abused- most people I have come across who take it without or with prescription are in fact snorting or injecting it. …Also, as far as cost, buprenorphine is only 10 dollars for an 8 mg pill here
Hopefully that’s a regional phenomenon, as it’s not widespread in the US at this point. You may be onto something with the price thing. In some European countries where they have socialized medicine and pharmaceutical opioids cost are about the same as Subutex, but not as available as Subutex, there have been reports of wider abuse. But for anyone intent on getting high, bupe blocks other opioids for days, has a limit to its effects, and can cause precipitated withdrawal if taken at the wrong time. This makes it less desirable than any full agonist, but if it’s all that’s available or much less expensive, that might increase the appeal. Heroin is $8 -$10/bag and usually overwhelmingly preferred by those not interested in addiction remission. I feel bad for those patients abusing bupe because now that they’ve associated the compulsive behavior of addiction with the bupe, it might not be nearly as useful for them should they survive to the point where they want to use it to achieve addiction remission.

Quote:
Originally Posted by ohmygoddess View Post
…The thing I never can understand is why the narcan doesn't has the precipitated withdrawal for the ones I have spoken to who have injected it on an ongoing bases. And this is Suboxone, not Subutex. Why doesn't it happen to them? I mean, yes some of these people have had to go to the ER for abscesses and infection. . .but it's as if the naloxone doesn't seem to block the buprenorphine….
The naloxone doesn’t affect the bupe much at all. The affinity of the bupe is stronger than the affinity of the naloxone. The purpose of the naloxone is to prevent misuse by injection by those who are physically dependent on full agonist opioids. Pages 23-24 in the TIP-40 explains it best.

Quote:
Originally Posted by ohmygoddess View Post
..One more thing I really want to know is why some people report not feeling any effect of full agonist opiates with a moderate dose of buprenorphine yet others report the buprenorphine has no blocking affect.
It’s because different people have different ceiling doses. At the ceiling dose the blocking is near total as virtually all available receptors are occupied with buprenorphine and cannot be dislodged by the full agonists since they have lower affinities to the receptors. At doses below that patient’s ceiling dose available receptors remain to accept the full agonists. This is why some doctors prescribe a high dose to patients at high risk of relapse who may only need a few mgs. to stop the cravings, the idea being that if they are at the full blocking dose if they did relapse it shouldn’t be long lasting since it would be blocked and they would reengage in treatment sooner.
Tim
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Unread 09-02-2010, 06:21 PM   #12
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Those people abusing the bupe could ruin it for everyone else. IMO- the DEA is looking for a reason to further restrict buprenorphine. Suppose they decide to ban or restrict the tablets, that would mean no generics, which means less patient choice.
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Unread 09-02-2010, 06:36 PM   #13
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Quote:
Originally Posted by TIM View Post
Those people abusing the bupe could ruin it for everyone else. IMO- the DEA is looking for a reason to further restrict buprenorphine. Suppose they decide to ban or restrict the tablets, that would mean no generics, which means less patient choice.
Tim

That would be a sad disgrace....moving in exactly the wrong direction, IMO. I have never seen bupe abused or diverted in my area, though that doesn't mean it doesn't happen. Ultimately, I would think the increased crime and suffering caused by further restrictions would be many, many times worse than any real or imagined diversion problems.
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Unread 09-03-2010, 10:56 AM   #14
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Hi toms,
When I was at the bupe summit in Washington this past May, a doctor asked the DEA why they are not recognizing the positive impact of public health of diverted buprenorphine. He said even though diversion is illegal many patients came to him for treatment because of their exposure to the diverted medication. He was concerned that the positive overall effect on public health was being ignored and even worse being mistaken for a public health threat, and would lead to further restricted access which would feed further diversion. I also contacted the DEA to offer our TreatmentMatch.org service to those doctors forced to decrease their patient roster. It would help abandoned patients find another doctor quickly, but they wanted no part of it. Instead, by not telling patients about this service many will enter the diversion market to self medicate, exactly opposite the mission of the “diversion control unit”. From these exchanges it appears the DEA is not interested in preventing diversion only enforcing it after the fact.

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Unread 09-03-2010, 01:39 PM   #15
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I think that, like many bureaucrats, DEA people have a main concern of covering their own ass and preserving their jobs. Its part and parcel of the problem of ever-expanding government....it ALWAYS grows, rather than shrinking. The "talk" is to help the addict, but the money is in packing them into the court system, etc. At least for those of us addicted to opiates, there are some solutions, because as has been demonstrated for years, detox and abstinence-based rehab doesn't offer much success.

I happened upon some interesting YouTube vids by a man calling himself "Suboxdoc". This guy is not only a practicing doctor, he's a recovering addict, and he offers quite the relevant viewpoint about many of the issues we see addressed over and over on here: stigma, myths, stopping suboxone. Maybe watching some of these will help others, I found them quite helpful to myself.
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Unread 09-04-2010, 11:04 AM   #16
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We all need to defend buprenorphine treatment! If Big Gov is only hearing from the DEA, they will take it away or restrict it away. Look what happened to handguns in the UK in 1997, nobody thought they’d ban handguns, but nobody opposed it and the law passed, then guns handed down from father to son for years, collections, were all confiscated and melted down, gun stores closed, ammunition stores closed, and ranges closed. The people were shocked, check out Youtube “UK gun control” http://www.youtube.com/watch?v=qGVAQOUi6ec

That Suboxdoc has some weird ideas too, for example he limits first few days dose even if someone is in withdrawal and makes them suffer through it. When most doctors now dose to effect and stop the withdrawal the first day. I've also seen him say some things that wern't true, not that he was lying he just didn't understand. I think he means well, but I think he is disturbed.
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Unread 09-07-2010, 02:00 PM   #17
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More info: http://www.heretohelpprogram.com/sub...m/Default.aspx
Excerpt: "Get an alert when SUBOXONE Film is in pharmacies—and learn about saving up to $75 on each fill"
Tim
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Unread 09-09-2010, 11:36 PM   #18
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Hi Tim, back on 9/3 you stated;

When I was at the bupe summit in Washington this past May, a doctor asked the DEA why they are not recognizing the positive impact of public health of diverted buprenorphine. He said even though diversion is illegal many patients came to him for treatment because of their exposure to the diverted medication. He was concerned that the positive overall effect on public health was being ignored and even worse being mistaken for a public health threat, and would lead to further restricted access which would feed further diversion. I also contacted the DEA to offer our TreatmentMatch.org service to those doctors forced to decrease their patient roster. It would help abandoned patients find another doctor quickly, but they wanted no part of it. Instead, by not telling patients about this service many will enter the diversion market to self medicate, exactly opposite the mission of the “diversion control unit”. From these exchanges it appears the DEA is not interested in preventing diversion only enforcing it after the fact.

Am I the only person in this ass-backward govt. run country of ours who thinks this is totally and completely asinine?
What does this say about the absolute lunacy and incompetence coming from the DEA?
They're not interested in preventing diversion, only enforcing it after the fact??
WTF kind of rationalization is that, and who are the F'ing morons who come up with this stuff, sorry Tim I'm not bitching at you by any means I just have to vent at this colossal act of STUPIDITY by another branch of our govt. who thinks they know what's best for its citizens and congers up idiotic ways like this to enforce their drug laws?
And lastly, who do this affect (hurt) the most?
Not the scumbag drug dealers or low life's who use and sell this wonder drug we call Suboxone, it affects people like ME who got addicted to painkillers from multiple surgeries from sport related injuries, to people like me Suboxone was almost impossible to get when I needed it the most, but after 4 years of being 100% clean, but not before begging and pleading with doctor after doctor which took almost 2 weeks during which my withdrawals were virtually debilitating to me to the point I could barely function....
That's our gov't agency who WE pay for, they (the DEA) don't give a shit about law abiding people like me, and they only want to go after you after the fact and try and crucify you for trying to clean up your act!
Where is the rationale from the DEA and why can't we ask them and hold them accountable for their stupid way of dealing with this, after all the last time I checked DEA is being paid by our tax dollars!!!!!!!!!!!!!

My apologies for my ranting, this is a very sensitive subject to me, I see how many lives Opiate addiction ruins and Suboxone for less of a better term is a "Miracle Drug", and the dopes down at the DEA need to stop trying to regulate this drug and concentrate their efforts on prevention of the heavy duty, full blown opiates out there that are killing and hurting so many people, Oh I forgot Tim you did say the DEA isn't in the act of prevention, they only enforce after the fact.........
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Unread 09-10-2010, 09:57 AM   #19
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VTsub007,
I'm as frustrated as you are about the DEA's overreaction and largely unwarranted attention toward buprenorphine and buprenorphine providers. For many physicians this was the last straw and many have stopped treated and fewer are becoming certified to prescribe, which was already an unprecedented laborious process not required with any other medication, even dangerous ones. For those who don't know, doctors must take a n 8 hour course, get a special DEA#, are now subject to unannounced DEA inspections, and are limited to how many patients they can save at any one time regardless of how many are begging for their help. Only 1 in 100 doctors are actually prescribing buprenorphine after almost 8 years of recruitment efforts.

Because it is so hard to find a doctor who prescribes the safer treatment medication, we created the patient matching system that automatically connects patients with doctors who have openings and are willing to treat them. I sent the letter below to the DEA in regards to this useful possibly lifesaving option. It was in response to a rash of emails from abandoned patients that was the aftermath of the DEA's announcement that they would be starting unannounced inspections of all DATA-2000 waived doctors (buprenorphine doctors). Their initial announcement was criticized for being intimidating, so in a follow-up apology letter they included instructions for doctors to surender their waivers and avoid the DEA intrution, this resulted in the abandoned patients, which prompted my letter, which was ultimately ignored. Does the letter seem reasonable to you?
Drug Enforcement Administration
Office of Diversion Control
Attn: Joseph T. Rannazzisi
8701 Morrissette Drive
Springfield, VA 22152
(202) 307-7165

October 14, 2009

Dear Mr. Rannazzisi,

A number of buprenorphine prescribing physicians have abruptly stopped treating patients citing either a pending DEA visit or the visit itself, according to dropped patients that are also members of our website. This results in more patients out of treatment and possibly seeking diverted buprenorphine in an attempt to self medicate, opposite of the DEA’s intent. I’m not faulting the DEA for doing its job, only bringing this to your attention and offering a solution.

Our 501(c)3 non-profit organization has a free online matching system that helps connect patients with certified buprenorphine providers. I recently sent referral cards to DEA field offices (sample enclosed) in case they were aware of a situation where patients were abandoned by their physician and needed another provider. Unfortunately, I received a call from one agent who explained they were unable to inform physicians of this lifesaving service.

If the DEA’s intent is to limit diversion, then it is also in their best interest to prevent dropped patients from remaining untreated and entering the diverted medication market. Therefore, I’m asking that you find some way to allow DEA field agents to communicate to physicians, who have the need to place patients with other physicians, that a service exists to do this, thus preventing dropped patients from seeking diverted medication. This would also be useful to physicians who have exceeded their patient cap and need to reduce their patient roster.

We have 2,650 participating physicians, and currently an 85% connection rate. Patients can register at www.TreatmentMatch.org I invite the DEA to work with the recovery community in a cooperative fashion and capitalize on the synergistic potential.

Thank you for your time,



Timothy P. Lepak
President, NAABT,Inc.
www.naabt.org
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Unread 09-10-2010, 11:40 PM   #20
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Tim,

Thank you for your response, you're as responsive now as you were 4 years ago!
All due respect your letter is great, however it's ONE letter, what if we got a "mass amount" of responses like your letter sent to the DEA, along with the complacent bureaucrats in Washington, not to mention we're coming into election season so my thoughts are to try and get as many people, patients, doctors, etc. to send letter like yours to the "out of touch" higher ups at the DEA along with senators like Orin Hatch from Utah, Carl Levin from MI & our distinguished (but not to smart) VP Joe Biden, heck they were the ones who introduced Hatch's legislation (S. 1887) back in 2004 which would eliminate the 30 patient limit ban altogether so doctors could begin treating many more addicts who desperately need help in getting clean, Sub. Is that drug.
So here we are in 2010 and the DEA is still scaring the shit out of potential doctors who would normally become a Sub. prescriber, if I was an MD I wouldn't touch it with a 10 ft. pole for fear "BIG BROTHER" AKA (DEA) is gonna come knocking on their clinic doors looking to shake these Dr.s up, and in doing so has just sent 100 patients from this doctors office out on the street to find the Sub. On the BLACK market!
No one from the DEA will explain to us the rationale behind this, I mean who are we to question that of the almighty D.E.A.!
We MUST demand that they do so we can change this Stupid, moronic, dumb, and ineffective way of trying to regulate this drug!!
We can do this Tim, we have to for all the honest, hard working people out there like me and countless others, IÂ’m sick and ****ing tired of having to work so hard to find a Dr. to help with my addiction, when the jerk-off drug dealers and low life sub-humans are out there peddling full blown opiates as well as Bup. to anyone who wants it as long as you're willing to pay up to, in some cases $100 a tablet!
I'm sure Dir. Hutchinson along with his army of robot attorney's will have some stupid ass, antiseptic, white washed come back, if it were ever to get to the top of the idiot heap at the DEA.

Thanks again Tim, we gotta keep trying to fight this, especially when it's so stupid like this!
Our tax dollars pay the salaries for all who work at the drug enforcement agency, if we yell and scream loud enough and have the balls to go up against the Blockheaded, thickheaded, Dense, Dumb, Dimwitted, and last but certainly not least, Hebetudinous (which is a fancy word for stupid) that is the DEA when dealing with Suboxone they will have no choice but to listen to us cretins............
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Unread 09-10-2010, 11:46 PM   #21
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A few days ago I saw a RB web cast about the new sub film and the local rep was able to provide me with inert samples. 2 and 8 mg films are the same size with the 8 mg film just miniscule thicker. The film melted under my tongue in under 1 ½ mins. For obvious reasons no one from the company would discuss cutting the film in half or less. But I was able to cut it into 1/8s and possibly could have done 1/16ths. 1/8 piece dissolved in under 20 secs. This is good news for those weaning. Research reveals that there is 40-50% mu receptor occupancy at the 2 mg dose. So anyone have difficulty reducing under 2 mg can now cut the 2 mg film into 1/8s and reduce 0.25 mg at a time, something unobtainable with the 2 mg tabs. Is this overkill, possibly, but if it helps who cares.
From reading some above posts, its seems a number of people rightfully have real worries about the continuation of the suboxone program. I have said the following over the last few years. Every time a post or thread starts a general gang banging of how all doctors are just money hungry unprofessional SOBs who don’t care about their patients, more ammunition is given to those in the government to reconsider the suboxone program. Read some of the threads about how some people hoard suboxone. 9 months and I seem to recall 1 year’s worth of medication has been allegedly squirreled away because of fear of unavailability. How do you think the DEA views keeping that much on hand. And, what goes thru their mind when they read about a poster who outright admits that he/she let their physician write for 16 mg a day when they have actually weaned down to 8 mg several months ago. RB and physicians have some real fears about the future of this treatment modality.
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Unread 09-11-2010, 09:00 AM   #22
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jdjk,

i get what you are saying, and the DEA have a job to do, made more difficult because of the intended purpose of this drug and its high visibility resulting on more scrutiny on them.

a while ago I started a thread about my physician who performs monthly GC/MS tests with bupe confirmation and I thought it was excessive, and perhaps it is. i wonder, however, if [part of] the answer to diversion and stockpiling could be somewhere in the middle with some kind of confirmation test. Correct me if I am wrong, but I understand it is possible to determine the level of bupe in an individual at time of testing. Without sacrificing the convenience of office visits (the last thing I would want to see is Sub relegated to dispensing only in clinics like methadone) would it be possible to insure that patients take the correct dose, minimizing stockpiling and diversion? I realize there are ways around this, particularly where monthly visits are the norm, but wouldn't a "standardized" testing regimen (where none exists today) take some of the pressure off?

Also, I want to thank you for answering some questions about the film strips. It is great to know that the 2/.05's can be cut to 1/16ths. I suspect that some of us who are "stuck" at 2mg or below may have greater confidence in tapering knowing that films can be accurately cut down.

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Unread 09-11-2010, 09:51 AM   #23
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omg I'm so excited! I see my doctor today I'll ask her about it.
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Unread 09-11-2010, 10:14 AM   #24
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Packrat
I have gotten conflicting answers from chemists and other experts about testing levels of any substance in the body. The companies that market the MS/GC testing state they can provide the answer with some degree of certainty if various info is provided (weight of the subject etc) with the sample. But others have insisted it is unreliable because of too many variables. My belief is that unless it is forensically accurate I would not want to judge anyone based upon a possible invalid finding. If my recall is correct there are some master level or higher chemists on this site who might provide a more substantial answer.
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Unread 09-11-2010, 11:06 AM   #25
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I am looking forward (for the first time) to a doctor appointment, it just makes me mad that the very people that keep us in the "stigma" box is a government agency. One poster said it so well, we have to send letters, stand up to them, educate them because they obviously still think we are stupid. When in fact it is the DEA or who ever that needs the educated responses from those of us that can express ourselves with the appropriate words and research. I'm not one of them, but I'm going to work on one.
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Unread 09-13-2010, 04:23 PM   #26
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MAN I wish they'd do one in Subutex, the Suboxone gave me such a headache.
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Unread 09-13-2010, 04:26 PM   #27
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jackie30,
You should try it and see if you still get the headaches, maybe the naloxone acts differently?? or maybe it was the timing, sometimes subutex causes headaches too in people when first starting, worth a try.
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Unread 09-15-2010, 03:02 PM   #28
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I may do that! Especially when I get lower, to be more exact. Thanks sarah!
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Unread 09-15-2010, 03:03 PM   #29
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Anyone gotten them yet?
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Unread 09-15-2010, 05:00 PM   #30
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I just called for my refill but will not be getting them until next month, because they will not have them for another 2 weeks. Both my doctor and pharmacist said that the rep and been in and showed them to them. They both said they were in individual tamper proof packages, not much taste and melted really fast. I am looking forward to trying them! I always keep my sub with me bouncing around in my purse. By the end of the month I have a bottle with little peices that broke off and the sub is light orange and does not feel as potent and melts really fast, making me wonder how much is absorbed. I think the individual packets will keep it really fresh. And also store better, for those of us that put a few aside for emergency. I also wonder if the will be easy to taper with, I forgot to ask, but wondering if you can cut the film stip into little peices? I was told they will have the 8mg and the 2mg. I sure wish they would make them is very small doses to make tapering easy! It sounds like the pharmacies will have them soon, I look forward to other's peoplle's experience, so I will know what to expect.
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Unread 09-16-2010, 04:30 PM   #31
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Any word if they will be allowed in Canada?
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Unread 09-17-2010, 11:16 AM   #32
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Quote:
Originally Posted by TIM View Post
Hopefully thatÂ’s a regional phenomenon, as itÂ’s not widespread in the US at this point. You may be onto something with the price thing. Heroin is $8 -$10/bag and usually overwhelmingly preferred by those not interested in addiction remission.
Tim
Wow, it's $40 a bag here IF you can get it and not get ripped off. All opiates go for 1 dollar per mg so an oxi 80 costs 80-100 dollars. So I guess because opiates are so expensive, abusing bupe is a cheap and more viable addiction. Who has $40 for just one bag. I mean, who even wants to do just ONE bag a day? Or who can even do just one a day.
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Unread 09-17-2010, 03:58 PM   #33
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My insurance covers Suboxone 8mg/2mg pill form.

How do you find out if insurance will cover the film. My doctor wanted to write a script for it, but I was hesitant because my Supplemental Insurance through Medicare does not list the film.

Do I contact my pharmacist and have him find out if my insurance will cover it.

Probably a no-brainer, I'm sure that's what I must do, but I have reservations, I don't want to get a script, and they not have it in stock.

What is the availabilty of the film.

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Unread 09-17-2010, 04:03 PM   #34
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Hi salgoud,
I'd kill 2 birds with one stone and call the pharmacy to check for availability and see if they can check the coverage. Its my understanding that it will be as widely covered as the tablet.

Make sure you get your $75 off card before filling it (if you have copay to apply it to)
Here's the site to print one out http://forheretohelpprogramsavings.c...aspx?cid=hthpf

The film should be available to all pharmacies by Oct 1, but some already have it.

Tim
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Unread 09-17-2010, 04:41 PM   #35
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Quote:
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... my Supplemental Insurance through Medicare....
I just found this about the discount card :
"This offer is not valid for SUBOXONE prescriptions covered under Medicare, Medicaid, TRICARE, or other federal or state assistance programs
..."

Here's more of the terms

This savings program covers up to $75 of your out-of-pocket expenses on each SUBOXONE Film prescription you fill through March 31, 2011. (Limit 1 prescription per month.) Savings on each prescription filled cannot exceed amount of copay. You may take advantage of only one savings offer from Reckitt Benckiser Pharmaceuticals Inc. at any one time.

This offer is not valid for SUBOXONE prescriptions covered under Medicare, Medicaid, TRICARE, or other federal or state assistance programs. Patients enrolled in the Reckitt Benckiser Pharmaceuticals Patient Assistance Program are not eligible to receive this offer. Offer void in Massachusetts. Void where prohibited by law, taxed, or otherwise restricted. The selling, purchasing, trading, or counterfeiting of this card is prohibited by law. Offer valid only at participating retail pharmacies in the US.

Limit 1 prescription per month and valid only in USA. Offer expires March 31, 2011. Reckitt Benckiser Pharmaceuticals reserves the right to rescind, revoke, or amend this offer without notice.

Your card has its own unique ID number. You can't transfer your card or provide a copy to another person; only you can use it. If you lose your card before the first time you use it, simply print out a new card at SuboxoneSavings.com and bring it to the pharmacy. If you lose your card after the first time you use it, tell your pharmacist so he or she can validate the transaction.


see this page for more details:

http://forheretohelpprogramsavings.c...aspx?cid=hthpf
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Unread 09-18-2010, 06:12 PM   #36
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Tim,

The rep has advised me that during the first month the card can be used twice, so the savings is $150 for the first month ONLY. Of cause this means the physician has to split the dose for the month.
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Unread 09-20-2010, 09:37 AM   #37
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Tim,

The rep has advised me that during the first month the card can be used twice, so the savings is $150 for the first month ONLY. Of cause this means the physician has to split the dose for the month.
Thanks I didn't know that!
Tim

Has anyone tried it yet? It's in some pharmacies now. I'm going to set up a new thread on patient evaluations, so we have them all in one place.
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Unread 09-21-2010, 08:01 PM   #38
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My psych offered me the coupon/trial and I declined. I currently take Subutex generic at a cost of $10 month.

On second thought, maybe I should take advantage of the trial. I can put them away and use them when I get to tapering for better accuracy. Cutting a piece of film into 16 equal pieces is feasible. So a scrip for 60 could yield almost 1000 .5mg doses. Not such a bad idea.
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Unread 09-21-2010, 09:41 PM   #39
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I posted this in the other thread, give it a read it's about price and availability.

http://www.addictionsurvivors.org/vb...29&postcount=3

I see above Tim posted that the price will be as same as the tablets, but what does that mean. I have seen the tablets go anywhere from $6 to $9 per pill. Is there a set price yet? None of the pharmacies I have called know and when I called Reckitt they said they didn't know how much the price was going to be.
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Unread 09-22-2010, 09:16 AM   #40
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I posted this in the other thread, give it a read it's about price and availability.

http://www.addictionsurvivors.org/vb...29&postcount=3

I see above Tim posted that the price will be as same as the tablets, but what does that mean. I have seen the tablets go anywhere from $6 to $9 per pill. Is there a set price yet? None of the pharmacies I have called know and when I called Reckitt they said they didn't know how much the price was going to be.
The pharmacies pay the wholesale price and they mark it up, so just as with the tablets it pays to shop around. So the wholesale price the pharmacies pay will be the same as they pay for the tablets. How much each decides to mark it up is unknowable now and subject to change, but likely the same as they did with the tablets. If you are paying cash you might be able to apply one of the other discount cards (like the AAA card) along with the $75 card?
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Unread 09-22-2010, 09:20 AM   #41
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My psych offered me the coupon/trial and I declined. I currently take Subutex generic at a cost of $10 month.

On second thought, maybe I should take advantage of the trial. I can put them away and use them when I get to tapering for better accuracy. Cutting a piece of film into 16 equal pieces is feasible. So a scrip for 60 could yield almost 1000 .5mg doses. Not such a bad idea.
If the card applies with your insurance, it will cover the $10 co pay and you'll be able to get the branded film product for the same price as the generic. If you do cut the film into smaller doses, make it a habit to keep the pieces in an old childproof tablet bottle. It will protect it from humidity too.
Tim
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Unread 09-23-2010, 12:35 PM   #42
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How cool is that?? Damn, wish they had that around when I was on sub. Oh well. Wonder if you can cut the strips down to make it easier tapering.

Very cool about the discount too.

-Mary
I was just prescribed the film by my Doctor yesterday. She says that they come in 8 mg strips (and also 2 mg from what I hear) but since I take 12 mgs of Suboxone I can vertically cut the strip in order to make it 4 mgs. So to answer your question of whether they can be cut or not?....Yes, it can be cut for easier tapering or for a variety of doses but cutting a 8 mg strip more than once may be a challenge so that's where a 2 mg strip will come in handy if they are actually available. She also gave me my discount card to save up to $75 until March of '11 for out of pocket expense for each time the prescription is filled. She did tell me that the box is coded in a way that you have to bring it back with you each month for your office visit or to the pharmacy (not sure which one) in order to get your refill for the next month. She said this is taking place in order to keep from being able to share your medication with others. Not sure how or what exactly she means but I will find out by doing more research or when someone sees this and can comment on since they know more about it. Apparently Suboxone is given away just like people share their opiates so they have found a way to try to prevent that! Imagine that!

Last edited by GettingThere; 09-23-2010 at 12:41 PM..
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Unread 09-23-2010, 01:02 PM   #43
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I cut the demonstration film (unmedicated version) and was able to get down to 1/8mg. pieces (0.125mgs) although the 1/8 were very small the 0.5mg was big enough to easily manipulate and handle. I also found it was easier to cut diagonally once down below 1mgs. I took pictures

Since the 2mgs film is the same size as the 8mg film, the same divisions would get you down to 1/32mgs (0.03125mgs)...way smaller than ever needed, but it would make .25mg and .125mg pieces very manageable.
Tim
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Unread 10-01-2010, 02:14 PM   #44
Kimmie3
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I was prescribed the strips yesterday and they are just as effective. And yes hopefully people who abuse suboxone wont be able to any longer with this new film- and for that I am very thankful. I never wanted to see suboxone become an abused street drug because it truly changed my life forever. Thanks for listening..kimmie3
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Unread 10-01-2010, 04:46 PM   #45
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I cut the demonstration film (unmedicated version) and was able to get down to 1/8mg. pieces (0.125mgs) although the 1/8 were very small the 0.5mg was big enough to easily manipulate and handle. I also found it was easier to cut diagonally once down below 1mgs. I took pictures

Since the 2mgs film is the same size as the 8mg film, the same divisions would get you down to 1/32mgs (0.03125mgs)...way smaller than ever needed, but it would make .25mg and .125mg pieces very manageable.
Tim

When actually holding a dime and looking at your pictures it really shows just how tiny the smallest cuts turned out. The first thing that came to mind was how much easier it will be for patients to consistantly measure whatever lower dose they're taking. Thanks for sharing the pic Tim.
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Unread 10-04-2010, 09:39 AM   #46
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...And yes hopefully people who abuse suboxone wont be able to any longer with this new film- and for that I am very thankful. I never wanted to see suboxone become an abused street drug because it truly changed my life forever. Thanks for listening..kimmie3
Good point. I think the anti-diversion characteristics of the film are the most important aspects. Office-based opioid addiction treatment, originated as an experiment to see if it could be done without an abuse level that exceeded the positive effects the treatment had on public health. There are provisions in the law to end it if it becomes a risk to public health. It is very disturbing that the DEA is placing so much emphasis on buprenorphine, which is already incredibly regulated. No other medication requires prescribers to get a special DEA#, or take an 8 hour course, even dangerous drugs.

One patient survey, cited at the buprenorphine summit in Washington last May, indicated that 90% of diverted buprenorphine in the US was being used for its indication to suppress withdrawal and cravings (rather than abused). When asked why they just don’t get it from a doctor since they are more or less taking it as directed, they cited access to treatment or unable to afford the doctor visits. By limiting the supply of prescribing doctors with unprecedented regulations and the threat of an unannounced DEA inspection, it not only limits access to treatment but also increases the prices doctors can charge, basic supply/demand economics. The regulations intended to prevent diversion appear to be the cause of great deal of it.

For anyone intent on “getting high” with buprenorphine, faces some undesirable realities.
1) it will block other opioids for days
2) it has a limited euphoric effect
3) it has a ceiling to those limited effects, where taking more doesn’t produce a noticeable difference.
4) it can cause withdrawal in people who are opioid physically dependent and still under the influence of opioids
5) due to supply limits, it is usually more expensive than full agonist opioids on the secondary market.
All of these reasons conspire to make buprenorphine an inconvenient and less desirable opioid for those who want to misuse it, especially when compared to other available full agonist opioids like heroin or hydrocodone, which doesn’t have any of the 5 issues stated above. With other prescribed opioids about 10% of those who take them lose control of their drug use. 100% of buprenorphine patients consist of these 10%, you would expect a very high rate of misuse since virtually all of the people taking it have already shown the inability to control opioid use, but you see the opposite. Instead, once stable buprenorphine patient quickly regain control of their drug intake and don’t run out of buprenorphine early or find multiple doctors to prescribe it, in fact more decrease their dose with time. This amazing transformation appears to be ignored by the DEA, otherwise they would see that to meet their mandate of reducing diversion would mean providing more access to buprenorphine not less.

Tim
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Unread 10-06-2010, 10:39 AM   #47
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Great post Tim!!

For those with the coupon.....I printed out the coupon and gave it to my pharmacy along with my written prescription. They then filled it, and gave the coupon back to me and told me I could keep using it until the expiration date, which is March of 2011. I just bring it with me each time I fill the prescription. I had a $20 copay before.

I think the best thing about the film is that you can cut in such tiny pieces. To me, this will make it alot easier, and more comforting, knowing i can taper off sub in as small of ecrements (sp) as I choose. I think its great!
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Unread 10-18-2010, 01:34 AM   #48
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Each packet has a bar code on it - it is linked to your name and Rx. If someone gets busted in possession of one of your doses it will link back directly to you. Also, look at the expiration date on the packets. Once opened that date is reduced dramatically. Hopefully the DEA will be satisfied with this effort to curb illegal sales/abuse.
It is a 'pita' to carry these on ones person though or to hide them at home (as compared to the pills) but I think worth it if it keeps the feds happy and the whole thing going. I had switched to Subutex as I my ankles were really swelling up when I was taking the Suboxone (4 years). My doc promised me that the film strips would not cause the swelling. I just started on the film 2 weeks ago and so far, so good.
Plus I no longer have to submit random urine samples - my doc was nervous about prescribing the Subutex and told me that spot checks would be necessary (at $50. a pop for me).
I really have to say this - it's been bothering me to the point that I stopped posting here for quite awhile now:
Why do people feel the need to 'post' all their ideas on how to use this life/sanity saving med (for me at least) in ways not intended or in some cases, not legal ??
To my mind this puts the 'program' (?? wtf do ya call it ?) in as much jeopardy as those diverting their Rxs to the street. Altering your dose in a manner not prescribed is technically abusing the medication. I've yet to read an 'idea' that I couldn't have thought of myself other than the tapering schedule, which. when done with the prescribing doctors orders, is ethical/legal/moral etc., etc. Sorry if this makes me sound like I think I'm 'holier than thou' - I don't. It just occurred to me one night, while reading here, that 'hey, if I'm reading this, who else is ?". Bad idea. I'm a dead man without this med so I do feel I have a vested interest with the continuation of
the 'initiative'... there... thats it, I'll call it an 'initiative' !! I'm open to any other names though that are better suited - feel free to advise me !
And I have to say, I DO NOT miss the 'taste' of the Suboxone or Subutex pills !
The film strips are a breeze and dissolve almost like cotton candy ! I make sure I have a pair of finger nail clippers in my pocket though before leaving the house - I can not get the packets open with my bare hands no matter where I try to tear the foil !
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Unread 10-18-2010, 10:11 PM   #49
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I had a Sub Dr appointment today and got the film strips (after calling my pharmacy to make sure they had it and printing the coupon). I also had my dose reduced today and am excited to try the film strips as I do believe I will get a more efficient absorbtion from them making my dose reduction go easier.
I will have my report ready for Thursday's chat session as promised...
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Unread 10-18-2010, 10:20 PM   #50
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I will have my report ready for Thursday's chat session as promised...
Detailed report, right? It's all in the details, Jim.

Glad the pharmacy had them and you could use the coupon!
Looking forward to Thursday now!

Nancy
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