Endo Pharmaceuticals Holdings Inc. said Wednesday its skin patch candidate aimed at delivering pain and inflammation treatment ketoprofen failed two late-stage clinical trials, forcing the company to withdraw guidance on when it might apply for Food and Drug Administration approval.
The drug developer had previously expected to file for approval in during the first half of 2008. The patch, being developed for the treatment of soft-tissue injuries, failed Phase III clinical trials dealing with ankle sprains and strains and pain associated with tendonitis or bursitis of the shoulder, elbow or knee. It failed to work any better than placebo in the studies.
A third Phase III clinical trial, also studying the patch as a treatment for tendonitis or bursitis of the shoulder, elbow or knee, is ongoing.
"Our initial view is that the results of the first two Phase III trials illustrate the difficulty of demonstrating a statistically significant separation between the treated and control groups in clinical studies involving topical patches," said Chief Scientific Officer Dr. David A. Lee. "Before determining our next course of action, we intend to review the results of these two trials in relation to the positive placebo-controlled trials conducted in Europe."