FDA turns down abuse-deterrent oxycodone ER capsules for pain

FDA has decided not to approve abuse-deterrent (AD) oxycodone extended-release capsules (Remoxy ER—Pain Therapeutics) for the treatment of severe pain. The drug's manufacturer said it has received a complete response letter from FDA that said the data submitted in the New Drug Application "do not support the conclusion that the benefits ...

FDA has decided not to approve abuse-deterrent (AD) oxycodone extended-release capsules (Remoxy ER—Pain Therapeutics) for the treatment of severe pain. The drug's manufacturer said it has received a complete response letter from FDA that said the data submitted in the New Drug Application "do not support the conclusion that the benefits ... outweigh the risks." The decision follows a June meeting in which FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted against recommending approval of the high-viscosity gel formulation pain drug. Participants at the meeting expressed concern about indications that material could still be extracted and used via the I.V. route as well as about the potential for oral abuse. Remi Barbier, president and CEO of Pain Therapeutics, called FDA's decision not to approve the AD drug "bizarre ... especially during a time of staggering human and economic toll created by opioid abuse and addiction."