Mallinckrodt Submits INDA For Synacthen Depot

Mallinckrodt plc MNK revealed Monday that it submitted an Investigational New Drug (IND) application for Synacthen Depot to the U.S. Food and Drug Administration (FDA). The company indicated that it would pursue an indication for the drug in treatment of Duchenne muscular dystrophy (DMD).

Mallinckrodt said Synacthen Depot was a depot formulation of Synacthen (tetracosactide), a synthetic 24 amino acid melanocortin receptor agonist. The company added that Synacthen Depot was approved and marketed outside the U.S. for some autoimmune and inflammatory conditions, but was never approved for use in patients in the U.S.

The company's SVP and CSO, Steven Romano, commented, "This IND filing is a critical step toward FDA approval of Synacthen Depot in the U.S. and a significant milestone for our organization. Mallinckrodt is committed to investing in reaching underserved patient populations with medicines that provide effective treatment in areas of high unmet medical need. We believe Synacthen Depot may have potential to offer physicians and patients a new alternative for this devastating disease that has very few existing treatment options."

Mallinckrodt said it invested substantially in the research program. That included completing the pre-clinical work necessary to support its IND application filing, and in transferring and updating manufacturing processes for the product. The company is committed to bringing this treatment option to patients suffering from this disease, and to working closely with the FDA.

The stock traded 4.41 percent down on Friday.