Endo Pharmaceuticals Says Patch Fails 2 Late-Stage Trials; Shares Fall
Published: Jul 12, 2007
The company's decision regarding the ketoprofen patch is based on the outcome of two Phase III double-blind, placebo-controlled clinical trials. One study evaluated the ketoprofen patch as a treatment for ankle sprains and strains, and the second was targeted at treating the pain associated with tendonitis or bursitis of the shoulder, elbow or knee. No statistically significant difference was observed in either trial in the primary endpoint -- average pain intensity during daily activities -- between patients treated with the ketoprofen patch and patients using a placebo patch.
A third Phase III study, evaluating the ketoprofen patch in the treatment of pain associated with tendonitis or bursitis of the shoulder, elbow or knee, is ongoing. An open-label, Phase III long-term (three months) study evaluating the safety of the ketoprofen patch in patients with osteoarthritis flare in the knee is also 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 David A. Lee, M.D., Ph.D., Chief Scientific Officer. "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. We expect to provide further clarification during our second quarter earnings call, tentatively scheduled for August 1."
About Endo Pharmaceuticals
A wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., Endo Pharmaceuticals is a fully integrated specialty pharmaceutical company with market leadership in pain management products. The company researches, develops, produces and markets a broad product offering of branded and generic pharmaceuticals, meeting the needs of healthcare professionals and consumers alike. More information, including this and past press releases of Endo Pharmaceuticals Holdings Inc., is available online at www.endo.com.
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Contact: Source: Endo Pharmaceuticals