Results Wire: US FDA Advisory Committee Unanimously Supports Approval of Collegium’s Xtampza ER, a Proposed Abuse Deterrent, Extended-Release Oxycodone Product – SEP 11, 2015 (AADPAC-DSRM)
On Friday, September 11, 2015, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) jointly supported, by a vote of 23-Yes to 0-No, with no abstentions, the safety and efficacy of Collegium Pharmaceutical Inc.’s Xtampza ER (oxycodone extended-release capsules), proposed for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate.