Suboxone: Generic at Last

02/28/2013

When the FDA approved generic buprenorphine, at that time only available as brand Subutex, I posed the question: Is Generic Buprenorphine Approval Another FDA Blunder? I believe my predictions came true. Patients demanded the cheaper generic buprenorphine. If lower cost failed to sway the prescribing physician, patients invented myriad adverse effects to procure prescriptions for the (presumably) more abusable and more divertable preparation which commanded higher prices on the street. Patients sought out physicians willing to prescribe the generic, eschewing those who refused.

Meanwhile, Reckitt-Benckiser, the company that originally marketed Suboxone and Subutex here in the U.S., developed and patented a sublingual film preparation whose individual wrappers they claimed would make the drug safer. R-B now plans to stop manufacturing the sublingual tablets on March 18.

Enter Amneal and Actavis. On February 22, 2013 the FDA approved generic preparations of buprenorphine/naloxone sublingual tablets.

When these drugs become available in pharmacies we should have a more affordable, yet less abusable, alternative for maintenance treatment of opioid dependence which should discourage the black market as well as removing the incentive for patients to fabricate adverse reactions. It should drive down the price of Suboxone film while we await FDA review of the buprenorphine implant (developed by Titan) later next month.

The only downside: Plaintiffs' attorneys salivating at the prospect of negligence claims when children overdose on the supposedly more dangerous tablets.

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Opinion