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.

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'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-term toxicology and multiple biocompatibility studies.

Phase IIb Trial

Objectives

• Primary objective: explore the minimally acceptable dose titration interval for transitioning opioid experienced patients to TRANSDUR-Sufentanil to achieve an acceptable analgesic and side effect profile.
• Secondary objectives:
  • Evaluate the relative potency relationship for converting patients from current opioid therapy to TRANSDUR-Sufentanil;
  • Evaluate the efficacy of TRANSDUR-Sufentanil administration; and
  • Evaluate the safety and tolerability (including local effects) of continuous TRANSDUR-Sufentanil administration at a dose delivering adequate pain control.

Design

The TRANSDUR-Sufentanil Phase IIb clinical trial was an open label, two-stage study to explore the titration (conversion) schedule for transitioning opioid-experienced patients with non-malignant moderate to severe chronic pain from current oral (e.g., OxyContin(R)) and transdermal opioid (e.g., Duragesic(R)) therapies to TRANSDUR-Sufentanil.