Saforis is an investigational therapy for the treatment and prevention of oral mucositis in patients receiving mucotoxic cancer therapy. The phase III trial of Saforis was conducted in patients with breast cancer who were receiving anthracycline-based chemotherapy regimens.
The primary endpoint of this trial, defined as a reduction in incidence and severity of oral mucositis, was met. Data from this study indicate that the incidence of oral mucositis was 38.7% in Saforis-treated patients compared to 49.7% in patients who received placebo. Overall, the data indicated that the safety profile of Saforis was comparable with that of placebo.
However, the FDA has requested an additional phase III trial of Saforis before it will approve the drug. MGI Pharma said it is currently evaluating options to maximize the value of Saforis.