NASDAQ: CRME TSX: COM
VANCOUVER, Jan. 27, 2016 /PRNewswire/ - Cardiome Pharma Corp. (NASDAQ: CRME / TSX: COM) today announced that it has filed with the FDA's Office of Orphan Products Development (OOPD) a request 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.
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.
The OOPD's target is to respond to the request within 90 days. If successful, Cardiome anticipates discussing an appropriate development plan for oral vernakalant in this orphan population with the FDA, utilising the various incentives that accompany such designation, including the waiver of various fees, tax incentives as well as improved post-approval market protections.
About Cardiome Pharma Corp. Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of cardiovascular therapies that will improve the quality of life and health of patients suffering from heart disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS® (vernakalant IV), approved in Europe and other territories for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults, and AGGRASTAT® (tirofiban HCl) a reversible GP IIb/IIIa inhibitor indicated for use in patients with acute coronary syndrome. Cardiome also commercializes Esmocard® and Esmocard Lyo® (esmolol hydrochloride), a short-acting beta-blocker used to control rapid heart rate in a number of cardiovascular indications, on behalf of their partner AOP Orphan Pharma in select European markets. Cardiome has also licensed TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension for Europe, the Middle East and for Canadian markets.
Cardiome is traded on the NASDAQ Capital Market (CRME) and the Toronto Stock Exchange (COM). For more information, please visit our web site at www.cardiome.com.
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SOURCE Cardiome Pharma Corp.