Durect says FDA advisory committee votes against approval of pain med

DURECT Corporation (DRRX) reported that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration voted 14 to 3 against the approval of REMOXY ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The development and commercialization rights of REMOXY ER are held by Pain Therapeutics (PTIE) under a license from DURECT. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is August 7, 2018.

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