FDA grants Fast Track designation to Mallinckrodt’s Synacthen Depot IND application

Mallinckrodt plc, a specialty pharmaceutical company and a worldwide leader, has announced that the U.S. Food and Drug Administration (FDA) recently granted its Investigational New Drug (IND) application for Synacthen Depot Fast Track designation.

"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," Mallinckrodt SVP and CSO Dr. Steven Romano said. "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."

Synacthen Depot is a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melnocortin receptor antagonist, and was developed for the treatment of Duchenne muscular dystrophy (DMD). The drug has currently received approval and is marketed outside the United States for specific types of autoimmune and inflammatory conditions. The drug has yet to be approved in the United States for use on patients.