Mallinckrodt plc, a leading global specialty biopharmaceutical company, has submitted an Investigational New Drug (IND) application for Synacthen Depot to the US Food and Drug Administration (FDA). The company will pursue an indication for the drug in 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 US for certain autoimmune and inflammatory conditions, but has never been approved for use in patients in the US.

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

"This IND filing is a critical step toward FDA approval of Synacthen Depot in the US and a significant milestone for our organization," said Steven Romano, M.D., senior vice president and chief scientific officer. "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's recent progress with Synacthen Depot exemplifies the company's commitment to innovation, and the company expects continued significant R&D investments in Synacthen Depot as this development programme progresses.   

Duchenne muscular dystrophy (DMD) is a genetic disorder characterized by progressive muscle degeneration and weakness. It is one of nine types of muscular dystrophy.

Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products.