Vernakalant (oral)
Cardiome is also investigating vernakalant in oral form for the chronic treatment of atrial fibrillation relapse. Vernakalant (oral) is expected to prevent or slow the recurrence of AF, and is designed to be used as a follow-on therapy to vernakalant (iv).
Phase 2a Trial
In Q4-2005, Cardiome initiated a Phase 2a clinical trial of vernakalant (oral) for the prevention of recurrence of atrial fibrillation.
The double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and preliminary efficacy of vernakalant (oral) over 28 days of dosing in patients at risk of recurrent atrial fibrillation. The majority of patients enrolled had experienced atrial fibrillation for greater than 30 days and less than 180 days in duration. Patients received a 300mg dose of vernakalant (oral), a 600mg dose of Vernakalant (oral) or placebo twice per day. After the first 3 days, patients still in atrial fibrillation were electrically cardioverted. Successfully cardioverted patients continued to receive vernakalant (oral) or placebo for the remaining 25 days and were monitored throughout the dosing period. The study was conducted across 72 centres in Canada, U.S. and Europe.
In September 2006, Cardiome announced positive final results from this study. (link)
Phase 2b Trial
In Q1-2007, Cardiome initiated a Phase 2b clinical trial of vernakalant (oral) for the prevention of recurrence of atrial fibrillation.
The double-blind, placebo-controlled, randomized, dose-ranging study was designed to explore safety and tolerability, pharmacokinetics and efficacy of vernakalant (oral) over 90 days of dosing in patients at risk of recurrent atrial fibrillation. Patients received a 150mg, 300mg or 500mg dose of vernakalant (oral) or placebo twice per day. After the first 3 days, patients still in atrial fibrillation were electrically cardioverted. Successfully cardioverted patients continued to receive vernakalant (oral) or placebo for the remainder of the 90-day trial and were monitored throughout the dosing period.
Positive final results from the study were released in July 2008. (link)