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REMOXY(R) NDA Filing Accepted by FDA and Priority Review Granted
Date:8/12/2008

CUPERTINO, Calif., Aug. 12 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) of REMOXY(R) and granted Priority Review. The FDA typically grants Priority Review to drug candidates that have the potential to demonstrate significant improvements compared to marketed products. The FDA goal for completing review of a drug with Priority Review status is six months from the date the application was submitted. The REMOXY NDA was submitted to the FDA by Pain Therapeutics on June 10, 2008.

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"We are pleased that the NDA has been accepted and that REMOXY will receive Priority Review," stated James E. Brown, DVM, President and CEO of DURECT. "The abuse of pain medications is a widespread problem in this country and addressing that issue is clearly in the public interest. We're delighted that our ORADUR(TM) technology has enabled the development of REMOXY, an investigational drug that has the potential to be the first oxycodone on the market that deters common methods of abuse."

REMOXY is being developed by Pain Therapeutics (Nasdaq: PTIE) under license from DURECT, and Pain Therapeutics has, in turn, sublicensed the commercialization rights for this drug candidate to King Pharmaceuticals (NYSE:

SOURCE DURECT Corporation
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