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FDA Approves Anti-Arrhythmic Drug, Tikosyn NEW YORK, N.Y. -- October 5, 1999 -- The U.S. Food and Drug Administration has approved the new anti-arrhythmic agent Tikosyn™ (dofetilide), Pfizer Inc. announced today. Tikosyn is indicated for the maintenance and conversion of normal sinus rhythm in patients with highly symptomatic atrial fibrillation (AF)/atrial flutter (Afl). Discovered and developed by Pfizer, Tikosyn is a selective potassium channel blocker and is the first new oral anti-arrhythmic for atrial fibrillation to be approved in the U.S. in the last 10 years. Atrial fibrillation is a form of cardiac arrhythmia in the U.S. and is growing due to the aging population. Patients with atrial fibrillation suffer from rapid and irregular heartbeats in the atria or upper chambers of the heart. Many patients suffering from AF experience debilitating symptoms that include chest pain, shortness of breath, fatigue and anxiety. Long-term treatment of atrial fibrillation is seen as a challenge by specialists due to concerns about safety of the currently available products and drug side effects, which leads to low compliance rates with medications. "We are pleased by the approval of Tikosyn because it provides an important new treatment in an area of cardiovascular medicine with limited therapeutic options," said Joseph Feczko, M.D., Senior Vice President, Medical and Regulatory Operations, Pfizer Pharmaceuticals Group. "The innovative Tikosyn research program has helped advance clinical understanding of the treatment of atrial fibrillation, which causes extensive suffering for patients." The clinical program included 8500 patients and was the largest ever conducted for an anti-arrhythmic medicine. The studies showed that Tikosyn was effective in maintaining patients in normal sinus rhythm for more than one year and also in converting patients back to their normal heart rhythm. Additionally, the Danish Investigations of arrhythmia and Mortality on Dofetilide in Congestive Heart Failure (DIAMOND-CHF) trial, recently published in the New England Journal of Medicine, included more than 1,500 patients and showed that Tikosyn did not increase mortality in the severely ill heart patients enrolled in the study, an important finding in this class of drugs. Like other anti-arrhythmic drugs, Tikosyn can cause pro-arrhythmias which can be life threatening. In clinical trials, the risk of induced arrhythmias was reduced by in-hospital initiation and adherence to a dosing algorithm. Therefore, Pfizer is developing a comprehensive program to educate institutions and healthcare professionals on the required in-hospital initiation and on the use of the unique dosing algorithm. Tikosyn will be available to prescribers and hospitals that have participated in the educational program. Tikosyn is expected to be available in first quarter 2000. Related Link: Pfizer Inc. E-mail this page to a friend or colleague! To print, use this version