Mallinckrodt (MNK) Granted FDA Fast Track Designation for Synacthen IND as DMD Treatment

August 25, 2016 7:31 AM EDT

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Mallinckrodt plc (NYSE: MNK) said the FDA has granted the company's request for a Fast Track designation for its Investigational New Drug (IND) application for Synacthen® Depot in the treatment of Duchenne muscular dystrophy (DMD). Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. Synacthen Depot is approved and marketed outside of the U.S. for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the U.S.

"We are pleased with the FDA's determination that our IND application for use of Synacthen Depot in treatment of Duchenne muscular dystrophy meets the agency's established criteria for a Fast Track designation, and are happy to report the first patients have been dosed in the initial phase 1 trial," said Steven Romano, M.D., Senior Vice President and Chief Scientific Officer. "DMD is a devastating disease for which there are few effective treatment options, and Mallinckrodt believes Synacthen Depot may have potential to offer physicians and patients a new alternative."

The agency's Fast Track designation is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions1.

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