Durect begins pivotal phase 3 program for pain medicine Remoxy

By E. Janene Geiss

Philadelphia, May 5 - Durect Corp. said Friday that a pivotal phase 3 program has been initiated for Remoxy, an abuse-resistant pain medicine under development based on Durect's patented Oradur technology incorporating the opioid oxycodone.

Pain Therapeutics, Inc., Durect's licensee of the rights to Remoxy and other Oradur-based products incorporating oxycodone and three other opioid compounds, said the program's Special Protocol Assessment has been approved by the Food and Drug Administration, according to a company news release.

About 20 clinical sites across the United States are now initiated for the study, officials said.

Officials said if Remoxy is approved, the drug will be commercialized by King Pharmaceuticals, Inc.

Products based on the Oradur technology can take the form of an easy to swallow gelatin capsule that uses a high-viscosity base component, Saber, to provide sustained release of active ingredients for a period of 12 to 24 hours of drug delivery.

Oral dosage forms based on the Oradur gel-cap may also have the added benefit of being less prone to abuse than other controlled-release dosage forms.

Remoxy is an oral, long-acting oxycodone capsule under development by Pain Therapeutics and King Pharmaceuticals that incorporates several abuse-deterrent properties and offers the convenience of twice-a-day dosing.

Remoxy is formulated with Durect's Oradur technology under a development and license agreement between Durect and Pain Therapeutics.

Durect is a Cupertino, Calif., specialty pharmaceutical company focused on development of pharmaceutical systems based on its proprietary drug delivery platform.

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