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Saforis is a proprietary oral formulation of L-glutamine developed by MGI Pharma (later acquired by Eisai) for the prevention and treatment of oral mucositis in patients undergoing cancer therapy. The product utilizes the UpTec delivery system, which is designed to significantly enhance the local delivery and uptake of glutamine into the damaged cells of the oral mucosa. L-glutamine serves as a vital energy source for rapidly dividing mucosal cells and acts as a precursor for the antioxidant glutathione, thereby supporting tissue repair and protecting against oxidative damage caused by chemotherapy or radiotherapy. In Phase 3 clinical trials involving breast cancer patients, Saforis demonstrated a significant reduction in the incidence of severe oral mucositis. However, following an approvable letter from the FDA in 2006 that requested an additional Phase 3 trial, development was eventually halted.
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