Shares of Cardiome Pharma Corp. (NASDAQ: CRME) are down 33% near market close, though pulling from a new 52-week low reached earlier in the day’s trading session. Cardiome this morning said the U.S. FDA has advised that the company’s proposed data package would not would not be sufficient to support a resubmission of the BRINAVESS New Drug Application (NDA). BRINAVESS is Cardiome’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). “In our most recent communication with the FDA, we proposed resubmission of the NDA based upon the original file and six years of accumulated safety data from sales of BRINAVESS in thirty-three countries, augmented by interim results from over 1,100 patients enrolled in the SPECTRUM study, a prospective post-authorization European Union safety study, along with pre-clinical data from subsequent studies the Company completed at the FDA’s request,” William Hunter, MD, CEO and president of Cardiome, stated in the news release. “We are disappointed that the Agency did not find these data compelling enough to recommend a resubmission, especially when several regulatory bodies in major jurisdictions around the world, including Canada in March 2017, have found the drug to be safe and effective. We will continue to have a dialogue with the FDA as we review our regulatory options.”
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About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a specialty pharmaceutical company dedicated to the development and commercialization of innovative therapies that will improve the quality of life and health of patients suffering from disease. Cardiome has two marketed, in-hospital, cardiology products, BRINAVESS® (vernakalant IV), approved in Europe, Canada, and other countries 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 Amomed in select European markets. Cardiome has also licensed: XYDALBA™ (dalbavancin hydrochloride), a second generation, semi-synthetic lipoglycopeptide approved in the EU for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults for select European and Middle Eastern countries and Canada from Allergan; and TREVYENT®, a development stage drug device combination that is under development for Pulmonary Arterial Hypertension for Europe, the Middle East and for Canadian markets from SteadyMed Therapeutics. 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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