Remoxy, an abuse-resistant pain medicine under development based on Durect Corporation's patented ORADUR technology incorporating the opioid oxycodone has successfully completed a Special Protocol Assessment with the US FDA and that a pivotal Phase III trial is being commenced on Remoxy in 400 patients with severe chronic pain.

The events were announced on February 16 by King Pharmaceuticals, Inc., the company which will be commercializing Remoxy, if approved, and Pain Therapeutics, Inc., Durect's licensee of the rights to Remoxy and other ORADUR-based products incorporating oxycodone and three other opioid compounds.

"We are very pleased with development progress of Remoxy and the clarification of the pathway to regulatory approval afforded by the Special Protocol Assessment," Jim Brown, President & CEO of Durect said.

Dr. Brown continued, "We are also delighted with the continued advancement of our ORADUR technology platform, and are excited about its potential as a platform for numerous other innovative products given its unique combination of sustained-release and abuse-resistant properties. We look forward to developing additional innovative sustained release oral gel-cap products that utilize opioids not subject to our alliance with Pain Therapeutics and King and other active agents prone to abuse."