Pain Therapeutics Announces Positive Regulatory Guidance for REMOXY™ ER

Submit the press release

AUSTIN, Texas, March 20, 2017 (GLOBE NEWSWIRE) — Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced positive regulatory guidance from a recent meeting with the U.S. Food and Drug Administration (FDA) regarding REMOXY (extended-release oxycodone capsules CII), its lead drug candidate.  The Company will host a conference call tomorrow morning at 8am EDT to discuss REMOXY, and to present a corporate update around partnership discussions and advances to its pipeline.
“In recent weeks we have worked closely with the FDA,” said Remi Barbier, President & CEO. “We appreciate their guidance, we understand their new requirements and we believe we’re now on track to make expeditious progress toward a resubmission of the REMOXY NDA.”Pain Therapeutics and the FDA met on February 13, 2017, to discuss REMOXY.  During this meeting, agreement was reached on additional studies that are needed for REMOXY’s approval.  We expect to complete these studies by year-end 2017, at a cost of approximately $3-4 million. Following completion of these studies, we intend to have a pre-NDA meeting with the FDA, followed by resubmission of the REMOXY NDA, with anticipated Priority Review, under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.Final Minutes of our FDA discussions confirm two requirements are needed for the resubmission of the REMOXY NDA:To conduct a clinical abuse potential study via the intranasal route of abuse; andTo conduct a non-clinical abuse potential study using household solvents.CLINICAL (INTRANASAL) ABUSE POTENTIAL STUDY
REMOXY has a sticky, high-viscosity gel formulation that cannot be snorted.   Therefore, our intranasal study will ask human volunteers to self-administer into their nostrils REMOXY, placebo or an active comparator.  Positive data in one intranasal study is adequate to support a label claim against the intranasal route of abuse.  We previously generated positive results using REMOXY under similar test conditions in a large animal model.