FDA committees to discuss two abuse-deterrent opioids

FDA's Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee will hold a joint meeting Sept. 10-11 to discuss a pair of NDAs for abuse-deterrent opioids. On Sept. 10, the committees will discuss an abuse-deterrent formulation of oxycodone immediate-release tablets from Purdue Pharma L.P. (Stamford, Conn.) to treat moderate to severe pain where the use of an opioid analgesic is appropriate. Purdue could not confirm the candidate's PDUFA date.

On Sept. 11, the panels will discuss Xtampza ER oxycodone extended-release from Collegium Pharmaceutical Inc. (NASDAQ:COLL) to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate. The PDUFA date for the extended-release oral oxycodone formulated with DETERx tamper resistance technology is Oct. 12. ...