- web-based article
- press release
Access Pharmaceuticals, Inc. announced today that it had received 501(k) clearance from the Food and Drug Administration to market MuGard in the United States.
MuGard is Access’ proprietary oral rinse product for the management of oral mucositis, the debilitating side-effect which afflicts more than 40% of cancer patients undergoing radiation and chemotherapy. There is currently no well-accepted treatment for mucositis, and the Company believes that MuGard should be a valuable supportive care option for cancer patients. The estimated size of the market for this indication in the U.S. exceeds $1 billion. The Company is actively seeking marketing partners for this product in the U.S. and in other territories.
Rosemary Mazanet, MD, PhD, Acting CEO of Access stated, “This approval marks a major milestone for the company following the decision to focus on the development and commercialization of proprietary products for the treatment and supportive care of cancer patients. We are in active discussions for licensing and manufacturing the product and expect to have more announcements in the future.”
In previously reported clinical studies MuGard prevented significant mucositis in over 40% of patients in a population where the incidence of mucositis normally exceeds 90%. In addition to the management of mucositis, the approved indication for MuGard includes all types of oral wounds, including aphthous ulcers (canker sores) and traumatic ulcers, such us those caused by oral surgery or ill-fitting dentures or braces. This broad-based approval provides the Company with the opportunity to promote the use of the product for several related oral ulcerative conditions.