Pain Therapeutics, Inc. (NASDAQ:PTIE)
Pain Therapeutics, Inc. (NASDAQ:PTIE) reported positive regulatory projection from a recent meeting with the U.S. FDA regarding REMOXY, its major drug candidate. Remi Barbier, the CEO and President, reported that in recent weeks they have worked closely with the U.S. FDA. They understand the new needs and consider that they are on track to make a refiling of the REMOXY NDA.
Pain Therapeutics, Inc. (NASDAQ:PTIE) and the FDA met in February, to discuss REMOXY. An agreement was made on additional trials that are required for REMOXY’s approval. They anticipate to close these trials by year-close 2017, at a cost of $3 to $4 million. Following completion of these trials, they plan to have a pre-NDA discussion with the FDA, subsequent to resubmission of the REMOXY NDA, with expected Priority Review.
Final Minutes of FDA discussions shows two requirements are required for the refiling of the REMOXY NDA, and they are to perform a clinical “abuse potential” trial through the intranasal route of abuse and secondly to perform a non-clinical abuse prospective trial utilizing household solvents.
REMOXY is a high-viscosity gel, sticky preparation that cannot be snorted. Hence, the intranasal trial will state human volunteers to self-administer into nostrils REMOXY, an active comparator or placebo. Promising reports in one intranasal trial is adequate to provision a label claim versus the intranasal route of abuse. They previously recorded promising report utilizing REMOXY under comparable test circumstances in a large animal model.
REMOXY’s high-viscosity, sticky formulation cannot be drawn via a normal size syringe. This feature makes it tough to abuse REMOXY through simple injection. Hence, they will perform an abuse potential trial in a lab utilizing thin films of REMOXY on glass plates to evaluate how household solvents impact the formulation. Promising data in this trial is adequate to advance a label claim against the injection route of abuse. They previously recorded promising results utilizing REMOXY under a similar test scenario.
The recent discussions with the U.S. FDA didn’t raise any concerns around drug efficacy, safety, stability, manufacturing or other drug advancement topics.
Shares of Pain Therapeutics, Inc. (NASDAQ:PTIE) gained over 16% on Thursday, hitting $0.898. However, this gain was not supported by strong volumes.
|Last Price a/o 3:21 PM EST||$0.90|
|Market Cap (mlns)||$ 40.25M|
|Shares Outstanding (mlns)||44.84M|
|Share Float (mlns)||33.66M|
|Short Interest Ratio||0.76|
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About the author: Monica Gray has an undergraduate degree in Accounting and an MBA – earned with Honors. She has six years of experience in the financial markets and has been a securities analyst for the past two years.