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The Food and Drug Administration has granted Fast Track Designation to Brilacidin-OM for the prevention of oral mucositis. The drug is an oral formulation of the drug Brilacidin, which is a defensin-mimetic. There are currently no FDA-approved drugs for the prevention of oral mucositis, according to a news release from Cellceutix Corporation, the drug company developing the drug.

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The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.


A Phase II trial to evaluate the safety and efficacy of Brilacidin-OM in preventing oral mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer is ongoing.