Cardiome Files Orphan Drug Application for Oral Vernakalant with U.S. FDA

Cardiome Pharma Corp. (NASDAQ:CRME, TSX:COM) has filed a request with the FDA’s Office of Orphan Products Development (OOPD) for orphan drug designation for an oral formulation of vernakalant hydrochloride, under the FDA’s Orphan Drug Act (ODA). The indication listed within the application is the prevention of post-operative atrial fibrillation in patients undergoing coronary artery bypass graft surgery.
According to the company’s press release:

To qualify for orphan designation, both the drug and the disease or condition must meet certain criteria specified in the ODA and FDA’s implementing regulations at 21 CFR Part 316, principal of which is that the disease or condition must affect fewer than 200,000 persons in the United States, that the medical needs of these patients are failing to be satisfied by currently available treatment options and that the drug in question has the potential to provide benefit.

Click here to view the full press release.