The US FDA has accepted MGI Pharma's new drug application for Saforis (glutamine in UpTec™) Powder for Oral Suspension, a drug candidate against oral mucositis in patients receiving mucotoxic cancer therapy, including chemotherapy. FDA will conduct a priority review and expects to release its decision by OCtober 12, 2006.
Oral mucositis, also called stomatitis, is a common complication arising from chemotherapy, characterized by formation of ulcerations and inflammation in the mouth. It affects an estimated 40% of patients undergoing mucotoxic cancer therapy, or about 2000,000 patients in the US each year.
In a Phase III clinical trial, Saforis has been shown to reduce the incidence and severity of oral mucositis in 326 breast cancer patients who were receiving anthracycline-based chemotherapy regimens. For more details, refer to MGI's press release.
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