Primary Endpoint of Pivotal Phase III Clinical Trial Achieved for ...(Application for Remoxy in Q2 2008. (L...),Health

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

"These positive clinical trial results represent a major validating milestone for the ORADUR technology which has the potential to serve as a platform for multiple drugs that require controlled release in an abuse deterrent form, and it takes us one step closer to the first NDA filing based on our ORADUR technology," stated James E. Brown, DVM, President and CEO of DURECT. "The abuse of pain medications is a widespread problem in this country and addressing that issue is clearly in the public interest."

Pivotal Remoxy Phase III Study (as reported by Pain Therapeutics and King Pharmaceuticals)

Design

This pivotal Phase III randomized, double-blinded, placebo-controlled, multi-center study was designed to evaluate the analgesic efficacy of twice- daily Remoxy versus placebo over a 12-week treatment period. The study randomized 412 male and female patients. All patients were diagnosed with osteoarthritis of the knee or hip, as evidenced by x-ray and clinical criteria of the American College of Rheumatology. Additionally, all patients had pain intensity scores corresponding to moderate-to-severe pain.

Following informed consent, wash-out and dose titration, patients were randomized (1:1) into a double-blinded treatment period (12 weeks). During treatment, patients received twice-daily Remoxy or matching placebo. The total drug dose per patient per day ranged from 10-80mg. Pain intensity scores were assessed on a Likert pain scale. Concomitant pain medications or rescue medications were not allowed at any point during the 12-week treatment period.

This Remoxy study received a Special Protocol Assessment (SPA) from the FDA. With an SPA, the study design, endpoints and statistical analyses needed to support approval were agreed upon by the FDA prio
'/>"/>