Data from Pharmawand - Curated by EPG Health - Date added 11 July 2018
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).