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Durect Posts Postive Phase I Results for Abuse-Resistant Opioid


Posted on 2006-11-30 13:58:00



Durect Corporation today reported positive results from a Phase I clinical trial evaluating an abuse-resistant opioid pain drug candidate based on its patented Oradur technology. The event was announced on November 29 by Pain Therapeutics, Inc., Durect's licensee of the rights to this drug candidate.

The Phase I clinical trial was designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of a single, oral dose of this drug candidate in healthy volunteers. As reported by Pain Therapeutics, this drug candidate was safe and well-tolerated, and its release profile appears well suited to use with a chronic pain population; there were no unexpected adverse events in this trial.

"We are pleased with the results and pace of this Phase I clinical trial," stated James Brown, chief executive officer of Durect. "We are delighted with the advancement of our Oradur technology platform and look forward to the continued progress of all of the products under the King Pharmaceuticals and Pain Therapeutics alliance."

This new drug candidate is the second Oradur-based opioid drug to undergo clinical testing by King Pharmaceuticals, Inc., the company which will be commercializing the drug candidate, if approved, and Pain Therapeutics, Inc., Durect's licensee of the rights to the drug candidate and other Oradur-based products incorporating oxycodone and three other opioid compounds. The first drug candidate under development by Pain Therapeutics and King Pharmaceuticals, Remoxy (Oradur-based oxycodone), is currently in Phase III clinical testing. The active pharmaceutical drug in the new Oradur-based opioid drug candidate has not been disclosed.


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