FDA advisory committee votes against approval of Pain's Remoxy

At a June 26 joint meeting, FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14-3 against approval of Remoxy ER oxycodone extended release (PF-00345439) from Pain Therapeutics Inc. (NASDAQ:PTIE) to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The NDA for the candidate has an Aug. 7 PDUFA date.

FDA has issued multiple complete response letters for Remoxy ER, including one in 2016 which cited the need for additional abuse-deterrence studies (see “Remoxy ER Oxycodone Extended Release Regulatory Update")...