FDA Grants Fast Track Designation For Cumberland Pharma's Oral Therapy Targeting Fatal Form Of Heart Disease In Duchenne Muscular Dystrophy Patients

Cumberland Pharmaceuticals Inc. (NASDAQ:CPIX), a specialty pharmaceutical company focused on developing new products for rare diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its novel oral therapy targeting a fatal form of heart disease in Duchenne muscular dystrophy (DMD) patients.

The FDA's Fast Track program facilitates the development and expedites the review of a drug designed to treat a serious or life-threatening condition and unmet medical need. This designation provides an opportunity for more frequent communication with the FDA, enabling Cumberland, as the sponsor, to obtain early feedback and guidance. Under Fast Track, Cumberland can also submit portions of an application for marketing approval on a rolling basis.