In September 2010, Merck (known as MSD outside the United States and Canada) and Cardiome announced that intravenous (IV) formulation of BRINAVESS™ (vernakalant) was granted marketing approval in the European Union (EU), Iceland and Norway for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults for non-surgery patients with atrial fibrillation of seven days duration or less and for post-cardiac surgery patients with atrial fibrillation of three days duration or less. BRINAVESS™ has been commercially launched by Merck in a number of countries, and further product launches are planned for the remaining countries for which marketing approval has been obtained worldwide.
BRINAVESS™ acts preferentially in the atria and is the first product in a new class of pharmacologic agents for cardioversion of AF to launch worldwide. To date, over 10,000 AF patients have had their recent onset AF episodes safely treated with BRINAVESS™.
The US FDA placed vernakalant IV on clinical hold during the Phase III ACT V trial in October 2010. Cardiome plans to work with the FDA to lift the hold and resume clinical development for the US market.
In September 2012, Merck returned global marketing and development rights for the vernakalant program back to Cardiome.