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Pfizer Receives Complete Response Letter from FDA for REMOXY®
Date:6/24/2011

ential benefits such as discouraging common methods of tampering, Pfizer's on-going review and interactions with FDA regarding approval of the REMOXY NDA and the potential of resolving all outstanding regulatory concerns regarding REMOXY, and the potential royalty and other payments that may be received by DURECT from REMOXY and other described products 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 potential that Pfizer may not be able to adequately address all of FDA's concerns regarding the REMOXY NDA or there could be a delay in addressing such concerns, the potential that FDA may not grant regulatory approval of REMOXY, difficulties or delays in the development, testing, regulatory approval, production and commercialization of REMOXY, and unexpected adverse side-effects or inadequate therapeutic efficacy of REMOXY that could slow or prevent product approval or market acceptance. Further information regarding these and other risks is included in DURECT's Form 10-Q dated May 5, 2011 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.


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