MGI Pharma has submitted a new drug application (NDA) for Saforis to treat oral mucositis in cancer patients.
Saforis is an oral formulation of glutamine delivered via the company's proprietary UpTec system that is intended to increase the uptake of glutamine by the oral mucosa to promote healing. The company is seeking an indication of prevention and treatment of oral mucositis in patients receiving mucotoxic cancer therapy.
The NDA is based on one Phase III trial and several supportive studies. In the Phase III study, which was conducted in 326 breast cancer patients undergoing chemotherapy, the Saforis group showed a reduction of severe oral mucositis compared to the placebo group.