FDA advisory panel votes against approval of Remoxy ER

Drug developer Pain Therapeutics (Nasdaq: PTIE) has announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration voted 14 to 3 against the approval of Remoxy (oxycodone extended-release capsules) 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.

Adding more pain for Pain Therapeutics, the firm’s shares plunged 70.69% to $2.50 in post-marketing trading on Tuesday.

Remoxy, the company’s lead product candidate, is an abuse-deterrent, extended-release, oral formulation of oxycodone, a widely prescribed opioid medication. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 7, 2018 for completion of its review of the New Drug Application (NDA) the drug.