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MGI Pharma submits new drug application for Saforis to FDA
By E. Janene Geiss
Philadelphia, April 13 - MGI Pharma, Inc. announced Thursday that the New Drug Application for Saforis (glutamine in UpTec) powder for oral suspension has been submitted to the Food and Drug Administration for review. Saforis, an oral formulation of glutamine in a proprietary delivery system designed to increase uptake of glutamine by the oral mucosa, is an investigational drug for the prevention and treatment of oral mucositis in patients receiving mucotoxic cancer therapy, according to a company news release.
One pivotal phase 3 trial and several supportive studies form the foundation of the Saforis application, officials said.
Results of the trial, completed in 326 patients with breast cancer who were receiving anthracycline-based chemotherapy regimens, showed that patients receiving Saforis experienced a 22% relative risk reduction of clinically significant oral mucositis compared with a placebo, officials said.
The primary endpoint, defined as a reduction in incidence and severity of oral mucositis, was met, officials said.
In addition, the incidence of severe oral mucositis was significantly reduced in Saforis patients when compared to a placebo, officials said. Side effects were mild in nature and similar to placebo.
Results of this study were first presented at the American Society of Clinical Oncology 2004 annual meeting, officials said.
Oral mucositis, a common side effect of mucotoxic cancer therapy, is characterized by painful ulcerations, redness and swelling in the mouth. It is estimated that approximately 35% of patients undergoing mucotoxic cancer therapy develop significant oral mucositis, which equates to more than 200,000 patients per year.
MGI Pharma is a Minneapolis biopharmaceutical company focused on oncology and acute care.
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