Pain Therapeutics (Nasdaq:PTIE), a drug development company, today announced 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 (FDA) voted 14 to 3 against the approval of REMOXY ER (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.

As quoted in the press release:

REMOXY ER, 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) for REMOXY ER.

Click here to read the full press release.