Pain Therapeutics reports successful FDA meeting relating to Remoxy, a drug for severe pain.

Pain Therapeutics, Inc., announced that it has successfully concluded a regulatory meeting with the FDA regarding Remoxy, a drug candidate for severe chronic pain. The purpose of this pre-New Drug Application (NDA) meeting was to agree on submission requirements for the Remoxy NDA under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

Pain Therapeutics received comments and clarification from the FDA on the acceptability of the data to be included in the Remoxy NDA resubmission, including a recent intranasal study. Following a successful conclusion of its meeting with the FDA, Pain Therapeutics intends to resubmit the Remoxy NDA in Q1 2018 with Priority (six-month) Review.

Comments: Remoxy is an investigational extended-release oral formulation of oxycodone for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Oxycodone is a source of significant drug abuse and the introduction of Remoxy as well as new versions of Oxycontin are intended to provide an abuse resitant formulation. Remoxy was developed by Pain Therapeutics, using DURECT Corporation' ORADUR technology, to help address the growing problem of non-medical use of prescription opioids. Remoxy is comprised of a high-viscosity, liquid formulation in a hard gelatin capsule that is designed to provide steady, around-the-clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone.