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Durect Corporation

Partner : Pain Therapeutics, Inc.

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DURECT Provides REMOXY® Update
Pain Therapeutics Announced today that an FDA Advisory Committee Meeting for REMOXY® is Not Needed and No Change to September 25, 2016 PDUFA Date
CUPERTINO, Calif., July 1, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has announced 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 5, 2016, is unnecessary and will not be held. REMOXY was previously the subject of an Advisory Committee meeting in 2008. Pain Therapeutics also stated that the FDA advised them that the regulatory review of the REMOXY New Drug Application (NDA) remains active and on-going. The Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA of September 25, 2016 is unchanged.
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Source: press release, 7/01/16. http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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DURECT Announces FDA Advisory Committee Meeting for REMOXY®
FDA's Tentative Date for Advisory Committee Meeting is August 5, 2016 and No Change to PDUFA Date of September 25, 2016
CUPERTINO, Calif., May 19, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has announced that an Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the REMOXY® New Drug Application (NDA), in a joint meeting of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee tentatively scheduled for August 5, 2016. Pain Therapeutics also stated that the FDA advised them that the Prescription Drug User Fee Act (PDUFA) date for the REMOXY NDA of September 25, 2016 is unchanged.
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Source: press release, 5/19/16. http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Remoxy (DUR)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