Pain Therapeutics, Inc. (NASDAQ:PTIE) investors are overwhelmingly excited today after the drug maker announced positive regulatory guidance from a recent meeting with the FDA regarding REMOXY (extended-release oxycodone capsules CII), the company’s painkiller product and its lead drug candidate.
“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; and
- To 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.
Non-Clinical Abuse Potential Study
REMOXY’s sticky, high-viscosity formulation cannot be pulled through a normal size syringe. This feature makes it difficult to abuse REMOXY via simple injection. Therefore, we will conduct an abuse potential study in a lab using thin films of REMOXY smeared on glass plates to assess how household solvents affect the formulation. We plan to generate these data against comparator products. Positive data in this study is adequate to support a label claim against the injection route of abuse. We previously generated positive results using REMOXY under similar test conditions.
Our recent discussions with the FDA did not raise any issues around safety, drug efficacy, manufacturing, stability or other drug development topics.
Shares of Pain Therapeutics are currently trading at $1.09, up $0.41 or 60%. PTIE has a 1-year high of $3 and a 1-year low of $0.51. The stock’s 50-day moving average is $0.61 and its 200-day moving average is $0.86.
Pain Therapeutics, Inc. is a biopharmaceutical company, which engages in the development of novel drugs. Its drug candidate includes REMOXY, which is a strong painkiller with a unique formulation designed to reduce potential risks of unintended use.