Results Wire: US FDA Advisory Committee Nearly Unanimously Withholds Support to Approve Purdue’s Avridi, An Immediate-Release, Abuse-Deterrent Formulation Oxycodone – SEP 10, 2015 (AADPAC-DSRM)
On Thursday, September 10, 2015, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSRM) jointly did not support, by a vote of 1-Yes to 23-No, with no abstentions, the safety and efficacy of Purdue Pharma’s Avridi (oxycodone immediate-release tablets) for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.