Pain Therapeutics has announced that it has successfully concluded a regulatory meeting with the US Food and Drug Administration (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. 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.
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. All questions were clearly and adequately addressed, and summarized in official minutes of the meeting recently issued by the FDA. There are no discrepancies or requests for clarifications following receipt of final meeting minutes.
"We appreciate the FDA's guidance and clarity as we prepare to resubmit the Remoxy NDA," said Remi Barbier, president & CEO of Pain Therapeutics.
Pain therapeutics, resubmit remoxy nda, q1 2018
