Pain Therapeutics Gains 7%, FDA Has Accepted Company's Remoxy For Review

Shares of Pain Therapeutics, Inc. PTIE, a micro-cap biopharmaceutical company whose lead drug candidate, REMOXY, is used for the treatment of moderate to severe pain.

Pain Therapeutics announced after Tuesday's market close the U.S. Food and Drug Administration determined that its New Drug Application (NDA) re-submission for Remoxy is sufficiently complete to permit a substantive review.

Pain Therapeutics added that the FDA has set September 25, 2016 as a target action date under the Prescription Drug User Fee Act (PDUFA).

"The acceptance of the REMOXY NDA marks another important milestone for Pain Therapeutics," said Remi Barbier, President and Chief Executive Officer of Pain Therapeutics. "We are grateful to the people, partners and patient investors who are helping to make this innovation a reality. We look forward to working closely with the FDA during the regulatory review process."