Biotechnology Events

Home

Pain Therapeutics, Inc.

.

PAIN THERAPEUTICS ANNOUNCES ADVISORY COMMITTEE MEETING FOR REMOXY® IS NOT NEEDED

No Change to September 25th PDUFA Date
AUSTIN, Texas, July 01, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that the U.S. Food and Drug Administration (FDA) has determined that an Advisory Committee meeting for REMOXY, which had been tentatively scheduled for August 5th, is unnecessary and will not be held. FDA also advised that the regulatory review of the REMOXY NDA remains active and on-going. The Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA is unchanged.

REMOXY was previously the subject of an Advisory Committee meeting. In 2008, REMOXY was discussed by the FDA's Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
More
Source: press release, 7/01/16. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=977979

.

PAIN THERAPEUTICS ANNOUNCES FDA ADVISORY COMMITTEE MEETING FOR REMOXY®

- August 5th is FDA's Tentative Date for Advisory Committee Meeting -

- No Change to PDUFA Date -

AUSTIN, Texas, May 19, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY® New Drug Application (NDA), tentatively scheduled for Friday, August 5, 2016. This is intended to be a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee.

"This could be a prime opportunity to showcase the abuse-deterrence and other properties of our lead drug candidate, REMOXY," said Remi Barbier, President & CEO of Pain Therapeutics. "We look forward to sharing our data with the FDA, Committee members and the general public."

FDA also advised us that the Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA, September 25, 2016, is unchanged.

About REMOXY ER (oxycodone capsules CII)
REMOXY ER is a proprietary, abuse-deterrent, extended-release oral formulation oxycodone (CII). The proposed indication for this drug candidate is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate." We developed REMOXY ER to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY's thick, sticky, high viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking. REMOXY ER targets the $2.5 billion marketplace for long-acting oxycodone. We own exclusive, worldwide rights to REMOXY ER.

The FDA has not yet established the safety or efficacy of REMOXY ER.
More
Source: press release, 5/19/16. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=971935

.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Remoxy (PTI)AnesthesiologyPain management (Tamper resistant)Opioid analgesick-opioid receptor agonist

Mechanism of action: Remoxy is an oral, long-acting oxycodone gelatin capsule, formulated to resist common methods of prescription drug misuse and abuse. Remoxy is in development for the treatment of moderate to severe chronic pain.

Phase of Development: Filed

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2016-08-05

Results: Discontinued