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DURECT Reports Positive Phase IIb Data from TRANSDU(TM)-Sufentanil Clinical Program
Date:3/16/2009

CUPERTINO, Calif., March 16 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today positive results from a 74 patient Phase IIb clinical trial conducted by Endo Pharmaceuticals of TRANSDUR(TM)-Sufentanil, a proprietary seven day patch under development for the treatment of chronic pain. The development program for this drug candidate was reviewed with the U.S. Food and Drug Administration (FDA) during a successful end-of-Phase II meeting with the FDA on February 19, 2009. As a result of that meeting, we believe we understand the anticipated regulatory pathway for the Phase III program and approval, which we expect will follow a 505(b)2 pathway as discussed with FDA.

(Logo: http://www.newscom.com/cgi-bin/prnh/20020717/DRRXLOGO)

"In this trial, all of the primary and secondary objectives were met by showing patients could be successfully converted from oral opioids such as OxyContin(R) and from fentanyl patches such as Duragesic(R) to TRANSDUR-Sufentanil, while also showing a reduction in pain scores on our therapy," stated James Brown, President and CEO of DURECT Corporation. "We believe that our small, patient-friendly seven day sufentanil patch would compete effectively in the chronic pain market including both patches and oral opioids."

In addition to the recent Phase IIb study, there have been 9 additional clinical studies performed to date with TRANSDUR-Sufentanil that have involved over 300 patient exposures. These studies include evaluating wearing, pharmacokinetics, specialty populations, repeat applications, skin abrasions, drug interactions and dose conversions. In addition, a non-clinical package comprising multiple animal safety studies has been developed, including carcinogenicity studies, long-ter
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