Vernakalant
Vernakalant (iv) is the intravenous formulation of an investigational drug being evaluated for the acute conversion of atrial fibrillation (AF). Vernakalant selectively blocks ion channels in the heart that are known to be active during episodes of atrial fibrillation.
Positive top-line results from two pivotal Phase 3 trials for vernakalant (iv), called ACT 1 and ACT 3, were released in December 2004 and September 2005. Cardiome’s co-development partner Astellas Pharma US, Inc. submitted a New Drug Application for vernakalant (iv) in December 2006. Positive top-line results from an additional Phase 3 study evaluating patients with post-operative atrial arrhythmia, called ACT 2, were released in June 2007. An open-label safety study evaluating recent-onset AF patients, called ACT 4, has completed.
Vernakalant (oral) is being investigated as a chronic-use oral drug for the maintenance of normal heart rhythm following termination of AF. Cardiome announced positive results from a Phase 2a pilot study for Vernakalant (oral) in September 2006, and announced positive results from a Phase 2b study for vernakalant (oral) in July 2008.
* Note: In September 2006, Cardiome announced that RSD1235 has been assigned the name "vernakalant hydrochloride" by the United States Adopted Names (USAN) Council. References to RSD1235 (iv) are now vernakalant (iv), and references to RSD1235 (oral) are now vernakalant (oral).