Endo Pharmaceuticals Inc, a wholly-owned subsidiary of Endo Pharmaceuticals Holdings Inc, announced results from its pivotal Phase III clinical trial of the investigational oral rinse EN3247 (0.1% triclosan) being evaluated for use in preventing oral mucositis (OM), which are painful mouth sores that often occur in patients undergoing cancer treatment.
Specifically, the study assessed the safety and efficacy of EN3247oral rinse for prevention of ulcerative oral mucositis resulting from cytotoxic conditioning regimens administered prior to autologous bone marrow or peripheral stem cell transplant therapy. These results indicated that EN 3247 did not meet its primary endpoint of preventing oral mucositis.
In the multi-center, randomized, double-blind, vehicle-controlled, parallel groups study, 355 patients undergoing autologous bone marrow or peripheral stem cell transplantation (involving chemotherapy and/or total body irradiation conditioning)were randomly assigned to one of three treatment groups: EN3247 oral rinse, vehicle control (placebo) or saline rinse (standard of care). Primary clinical endpoints were the presence or absence of ulcerative mucositis as well as the duration (days) of intraoral ulcers. Severity of erythematous mucositis, oral pain and difficulty in swallowing also were assessed. Statistical significance was not achieved in the comparison of active treatment versus vehicle or standard of care.
Carol A. Ammon, Chairman and Chief Executive Officer of Endo Pharmaceuticals, said, "Naturally, we are disappointed that we were unable to confirm the efficacy of EN 3247 in patients suffering from oral mucositis, and we will continue to analyze the data from the program to determine the future of this product."