About the Development Program for Remoxy (as announced by King and Pain Therapeutics)
The development program for Remoxy consisted of several clinical
studies, including one pivotal Phase III study conducted under a Special
Protocol Assessment (SPA), which evaluated the safety and efficacy of
Remoxy in over 400 patients with osteoarthritis. With a SPA, the study
design, endpoints and statistical analyses needed to support approval were
agreed upon by the FDA prior to initiating the study and are considered
binding. Pain Therapeutics and King have stated that they believe that the
SPA for Remoxy remains in full-force without modification. The following
summarizes the pivotal Phase III results:
-- Pursuant to the SPA, the primary endpoint of the Remoxy pivotal Phase
III study was defined as mean decrease in pain intensity scores between
Remoxy and placebo during the 12-week treatment period.
-- The study achieved a statistically significant result in its primary
endpoint (p less than 0.01).
-- In addition, the study achieved statistically significant results in
secondary endpoints such as Quality of Analgesia (p less than 0.01) and
Global Assessment (p less than 0.01).
About Oxycodone Abuse
|SOURCE DURECT Corporation|
Copyright©2008 PR Newswire.
All rights reserved