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

CUPERTINO, Calif., June 24, 2011 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today reported that Pfizer Inc. (NYSE: PFE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for REMOXY®, a controlled-release form of oxycodone designed to discourage common methods of tampering.  Pfizer stated that it is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them.

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"Pfizer has an experienced team of scientists dedicated to resolving the remaining issues," stated James E. Brown, D.V.M., President and CEO of DURECT Corporation.  "The misuse and abuse of pain medications is a widespread problem in this country and we will continue to support Pfizer in their efforts to address this important public health and safety issue."

REMOXY, based on DURECT's ORADUR® technology, is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use.  Approximately 50 million Americans suffer from persistent pain each year, according to the American Pain Foundation.

About ORADUR® Technology

ORADUR is a proprietary technology designed to transform short-acting oral capsule dosage forms into sustained release oral products, with the added benefit of resisting common methods of prescription drug misuse and abuse compared to other controlled release dosage forms on the market today.

Corporate Relationships

In December 2002, DURECT licensed to Pain Therapeutic
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SOURCE DURECT Corporation
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