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New Drug Application Submitted for Remoxy(TM) (ORADUR(TM)-Based Oxycodone)
Date:6/10/2008

ordance with the FDA's Electronic Common Technical Document specifications. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether to accept the NDA for filing within 90 days. At that time Pain Therapeutics will also learn if the NDA filing was granted priority review. A Priority Review designation is given to drugs that offer real advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a NDA is reduced from 12 months to approximately 6 months.

About the Development Program for Remoxy (as announced by King and Pain Therapeutics)

The development program for Remoxy consisted of several clinical studies, including one pivotal Phase III study conducted under a Special Protocol Assessment (SPA), which evaluated the safety and efficacy of Remoxy in over 400 patients with osteoarthritis. With a SPA, the study design, endpoints and statistical analyses needed to support approval were agreed upon by the FDA prior to initiating the study and are considered binding. Pain Therapeutics and King have stated that they believe that the SPA for Remoxy remains in full-force without modification. The following summarizes the pivotal Phase III results:

-- Pursuant to the SPA, the primary endpoint of the Remoxy pivotal Phase

III study was defined as mean decrease in pain intensity scores between

Remoxy and placebo during the 12-week treatment period.

-- The study achieved a statistically significant result in its primary

endpoint (p less than 0.01).

-- In addition, the study achieved statistically significant results in

secondary endpoints such as Quality of Analgesia (p less than 0.01) and

Global Assessment (p less than 0.01).

About Oxycodone Abuse

Please visit the U.S. Drug Enforcement Administration's website for more information:

SOURCE DURECT Corporation
Copyright©2008 PR Newswire.
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