Specifically, the study assessed the safety and efficacy of ENoral 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 indicated that EN did not meet its primary endpoint of preventing oral mucositis. 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 ificance 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 in patients suffering from oral mucositis, exchage will continue to analyze the data from the program to determine the future of this product. 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.
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