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DURECT Announces Intent To Submit NDA For POSIDUR™ For Post-Operative Analgesia

About DURECT Corporation

DURECT is a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY ®, POSIDUR , ELADUR ®, and TRANSDUR ®-Sufentanil.  DURECT's proprietary oral, transdermal and injectable depot delivery technologies enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs.  For more information, please visit www.durect.com.

DURECT Forward-Looking Statement

The statements in this press release regarding DURECT's intention to prepare and submit a new drug application with the FDA for POSIDUR in late 2012 or early 2013, and the potential benefits and uses of POSIDUR are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risk that the NDA submission may not occur in late 2012 or early 2013 as intended, the risk that if submitted the FDA may not accept the NDA for review and, if reviewed by the FDA, will not be approved by the FDA, requests for additional information or analysis by the FDA, including additional clinical trials, delays and additional costs due to requirements imposed by the FDA, potential adverse effects arising from the testing or use of POSIDUR, failure to manufacture, and commercialize or obtain marketplace acceptance of POSIDUR, the risk of patent validity being challenged and not upheld, and the risk of infringing patents held by other parties. Further information regarding these and other risks is included in DURECT's Form 10-Q on May 4, 2012 under the heading "Risk Factors."

NOTE: POSIDUR , SABER ®, ORADUR ®, TRANSDUR ®, and ELADUR are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.  REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

SOURCE DURECT Corporation

Copyright 2011 PR Newswire. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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