Thursday, October 29, 2009

Is Generic Buprenorphine Approval Another FDA Blunder?

Suboxone maintenance patients will likely rejoice almost as much as third party payers over the imminent availability of a generic, but the FDA should not make buprenorphine available until after the combination buprenorphine/naloxone (Suboxone).

The idea of combining naloxone, an opiate antagonist that can only act when injected, with the mu opioid partial agonist buprenorphine for treatment of opiate addiction is to discourage addicts from injecting the drug to get high. Standard practice calls for use of buprenorphine alone (Subutex) only during pregnancy and a few other situations where it is possible that the naloxone contributes to rare adverse effects. Although I cannot claim to have priced these drugs on the street I suspect buprenorphine brings a higher price, and many of my patients have attempted to get me to prescribe it for dubious reasons.

Given the high price of Suboxone and Subutex in the pharmacies we have all eagerly awaited the arrival of cheaper alternatives. While I am glad more patients will be able to afford treatment with adequate doses, I believe many will want to switch from Suboxone to generic buprenorphine, and that this will lead to more abuse and diversion. Delay in release of the buprenorphine until after release of the combination could have prevented this. What could the FDA have been thinking?

Increase in buprenorphine availability accompanied by lower price on the street may also lead more addicts to attempt to treat themselves rather than incurring the expense of medical supervision. And since many patients (and even a few docs) seem to wrongly assume that precipitated withdrawal results from the naloxone, we may see an increase in that phenomenon when naive addicts use the drug too soon after stopping whichever full agonist they were dependent upon.

Let us hope the FDA approves a generic buprenorphine/naloxone product post haste and that its price makes it just as much of a bargain as buprenorphine alone for saving lives. And do not switch from the combination to the new generic for financial reasons alone.


  1. well, like usual, another silly article written by a person i can only assume has no real experience with the drug. let me clear a couple things up for those who either do not know or are mis-informed. the naloxone in suboxone is more of a nice idea to put people (like yourself) at bay for fear that a recovering addict might get the chance to get high on illicit opiates. however, it's the partial opiate in this formulation, buprenorphine, that prevents users from successfully abusing other opiate medications. the amount of naloxone in most typical doses of suboxone (8mg or less of a suboxone, so 2 mg or less of the naloxone) is NOT enough to really block a breakthrough from full agonist opiates, it takes a far higher dose of naloxone to achieve any true blockading effect (example: a person taking a small dose of ONLY naloxone can easily get high if they use enough of their drug of choice to "break through," then they can now easily use as much opiate as they want with zero blockade effect from the naloxone). the reason people cannot get high on other full agonist opiates while taking suboxone is due to the BUPRENORPHINE, NOT THE NALOXONE in the formulation. bupe also stays in the system (very long half-life) for a long time which is why the suboxone user cannot get high off other opiates for several days or more after taking their last dose. Get your facts straight, in all reality suboxone is a horribly overpriced alternative to the new generic formulations of buprenorphone. my doctor even tells me so, and he's right. Competition is a good thing, and i really feel that people are not educated on this subject and they end up writing mis-informing articles like the one you see above posted by moviedoc. generic subutex saves MANY MANY people ALOT OF MONEY! People who can probably use that money for much better things, like paying bills. Now addicts who could not formerly afford suboxone can afford the new generic; wow, they can have their cake and eat it too! Buprenorphine saves people's lives and it shouldn't be looked at with such stigma, the people taking bupe are doing so because they chose to change their lives and get clean. there's alot worse things they can be doing besides putting a pill under their tongue to not hurt, like robbing you or me or some poor schmuck at gunpoint to get cash for their next fix. i feel that i have clearly articulated the facts and thus proved my point, thank you.

  2. This comment is valid. And I'm surprised to see the author of this blog speaks of 'patients of his or hers'. I really hope you aren't so ignorant to have passed the certification and treat your patients without any pharmacology education. The author is merely regurgitating the lies of the FDA who refused to approve Buprenorphine for almost a decade because of fear of introducing another injectable opioid. The nalaxone is just to satisfy the FDA and frankly the generic buprenorphine should have been available a long time ago. The only effect of nalaxone is an adverse reaction among some patients, and the possibility of intensifying precipitated withdrawals. Precipitated withdrawals will occur regardless of the presence of nalaxone, but may not be as severe.

    Unfortunately Reckitt Benckiser are suing the generic makers at the moment and the generic is unavailable. What a terrible industry and an even worse oversight committee like the FDA. And R/B can Benckiss my ass. Even the pharmaceutical industry is full of ignorant bureaucrat assholes trying to wring every penny out of the addicts you've created.

    If it wasn't for insurance there is no way I would be able to afford my Suboxone which costs $1,125 a month. I'm about to lose my insurance and the generic has been suspended. The generic costs $60 a month in comparison.

    You monsters, stop blaming the victims for myths about diversion and nalaxone that you've been lead to believe. Stop blaming the people who need it the most. Most diverted subs are used for their intended purpose. Very few people out there are injecting subutex. The nalaxone has virtually no effect regardless of its presence. If some tool wants to inject bupe, they can inject it with nalaxone.

  3. Conkelly: I agree with most of what you say, but the naloxone in Suboxone taken sublingually as it should be taken does not get into the blood, much less the brain, either not at all or not in high enough concentration to have significant effect. One question though: How do those addicts who can't afford Suboxone afford Oxycontin or heroin?

    Anonymous: You say FDA insisted on a naloxone combination. How do you know it wasn't DEA? That's a very interesting question. You say generic bupe should have been available before, but without a patent to protect rights to produce the drug for a sufficient period of time neither R-B nor anyone else would have wanted to invest the money to apply for approval. I had not heard about a lawsuit. One of the patients I treat reported getting the generic pretty recently.

    Who "created" those addicts? Heroin and alcohol have been around way longer than than big pharma, buprenorphine is the only addictive drug I prescribe (with very few exceptions), and it's my understanding even addicts choose to stop using and go through withdrawal on their own. $1,125 a month for Suboxone? Patients have told me they spent $400 a DAY for Oxy.

    What do you think of my proposed solution? Doctors start prescribing buprenorphine (either -tex or -one) for pain instead of oxy or hydrocodone. They can do that now -- legally, off label. I think fewer people would get addicted, and fewer would die of OD.

  4. Hello all i think the nalaxone in suboxone is all a joke people are always going to abuse anything. This nalaxone all it is is a pawn so that these crooks Rickets and benkeser can keep the patent till 2025 so they can make a killing why did they put a drug on the market that they did not even let you know how to get off Of This stuff. They should be sued by all who were put on it I have been on it for 3 years now i can not take the nalaxone in the suboxone it makes me have swollen legs, headaches,stomach problems so i have been on subutex weaning off of the brand now they stop making it so i have to start taking the generic which all are different as of now there are 3 makers all different and i do not abuse them i go to work everday now with the generic i feel different like it is not working
    i think the fda on all drugs has let some terrible drugs be out there as generics such generics cost less cause they are all inferior That is Why They Cost Less What A Country the proud land of the free lets not get into that
    it is all a scam