Cardiome Pharma Corp announced the initiation of its third Phase 3 efficacy study of RSD1235 for the acute treatment of atrial fibrillation. The study, called ACT 3 (Atrial arrhythmia Conversion Trial 3), is being conducted by co-development partner Fujisawa Healthcare Inc and will measure the safety and efficacy of RSD1235 in recent onset atrial arrhythmia patients. The placebo-controlled study is being carried out in more than 50 centres throughout the world, a company release said.
In October 2003, Cardiome licensed North American rights to the intravenous formulation of RSD1235 to Fujisawa Healthcare Inc. Under the terms of the agreement Cardiome granted Fujisawa an exclusive license to develop and commercialize intravenous RSD1235 in North America. The companies will co-develop RSD1235 IV to NDA, with Fujisawa responsible for 75 per cent of development costs. Cardiome has retained all rights to the intravenous formulations outside of Canada, US and Mexico, and has also retained worldwide rights to oral RSD1235 for the prevention of AF.
Atrial fibrillation is an abnormal heart rhythm that affects the atria of the heart, lowering the heart's pumping capacity and increasing the risk of stroke. Immediate symptoms are breathlessness and fatigue. Long-term effects include increased risk of both stroke and congestive heart failure. In 2002 there were over 7 million cases of atrial arrhythmia in the developed world. The acute in-hospital market is poorly served by existing drugs. Currently available drugs lack sufficient efficacy and put patients at risk for potentially fatal side-effect arrhythmias. The common initial approach for the treatment of chronic AF is by electrocardioverting (electroshocking) the patient, an invasive and expensive procedure. Establishment of safety and efficacy will be key to RSD1235 emerging as the potential drug of choice for the management of paroxysmal and persistent AF.
The ACT 3 study protocol was designed with the input of leading research cardiologists, including the co-chairs of the steering committee of the trial, Dr. Craig Pratt from Baylor College of Medicine and Dr. Denis Roy from the Montreal Heart Institute. The Data Safety Monitoring Board for the study is chaired by Professor John Camm of St George's Hospital, London, a long-time leader in antiarrhythmic drug research.
Cardiome Pharma Corp is a product-focused cardiovascular drug development company with three late stage clinical drug programs focused on atrial arrhythmias, congestive heart failure, and hyperuricemia (gout).