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FDA's Fast Track Status to Brilacidin-OM for Oral Mucositis

doi: 10.1097/01.COT.0000480396.92165.bc
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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.

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.

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