The U.S. Food and Drug Administration (FDA) has granted fast-track status to biopharmaceutical company Cellceutix for Brilacidin-OM, a mouth rinse to prevent oral mucositis.
Cellceutix is conducting an ongoing phase II trial to evaluate the safety and efficacy of Brilacidin-OM in patients undergoing chemoradiation for the treatment of head and neck cancer. There are currently no FDA-approved drugs to prevent oral mucositis, according to the company.
"Hundreds of thousands of patients suffer from oral mucositis each year, including many of the approximately 60,000 patients diagnosed with head and neck cancer, with no drug available to help prevent it," said Leo Ehrlich, CEO of Cellceutix, in a press release. "The fast-track designation provides us a greater opportunity to interact with the FDA and the possibility of other programs to assist in hastening the development of Brilacidin-OM."
