Access files 510(k) for MuGard oral rinse

By Lisa Kerner

Charlotte, N.C., Sept. 20 - Access Pharmaceuticals Inc. submitted a 510(k) Premarket Notification Application to the Food and Drug Administration to market MuGard, its proprietary oral rinse product for the prevention and treatment of oral mucositis, a debilitating side effect of radiation and chemotherapy treatments for cancer.

Studies showed MuGard prevented significant mucositis in more than 40% of patients in a population where the normal incidence exceeds 90%. The estimated size of the market for this product in the United States is estimated at $1 billion.

The Dallas biopharmaceutical company said it is actively seeking marketing partners for its MuGard product.

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