FDA advisory committee votes 14-3 against approval of Remoxy ER for the management of severe pain.- Pain Therapeutics Inc.

Pain Therapeutics, Inc., 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 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.

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 7 August 2018 for completion of its review of the New Drug Application (NDA) for Remoxy ER.

Comment: Most members of the agency's anesthetic/analgesic drug products and risk management/drug safety panels concluded that Pain Therapeutics had established Remoxy�s ability to deter intranasal abuse. However, they were troubled by the safety and public health implications of the product�s intravenous abuse potential � concerns that FDA reviewers and the panel equated to those that led to the withdrawal of Endo Pharmaceuticals Inc.�s Opana ER (oxymorphone extended-release).