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Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Committee

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.