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Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for REMOXY ER
Jun. 27, 2018 09:02AM PST
Pharmaceutical InvestingPain 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 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.
