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.

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