In a Joint Meeting, Advisory Committees Recommend Approval of Abuse-Deterrent Opioid

April 11, 2017

In another attempt to quell the opioid abuse epidemic, two FDA advisory committees voted Wednesday to recommend approval of an NDA for an immediate-release opioid painkiller.

FDA commissioner nominee Scott Gottlieb said in a Senate confirmation hearing that opioid abuse will be one of his top priorities if confirmed.

The drug is formulated to deter nasal and intravenous abuse. In a 19-to-0 vote with one abstention, the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Product Advisory Committee recommended that FDA approve Inspirion Delivery Sciences’ oxycodone hydrochloride, with the proposed tradename RoxyBond.

After considering the clinical trial evidence presented by the drug’s sponsor, the committees voted 19-to-1 to recommend that RoxyBond, if approved, carry labeling describing its ability to deter abuse via the nasal route. They also voted 16-to-4 in favor of abuse-deterrent labeling via the intravenous route.

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