Azimilide (Procter & Gamble)

Azimilide is a class III anti-arrhythmic agent under development by Procter & Gamble. In December 1998, the company submitted an NDA with the FDA seeking an indication for the maintenance of sinus heart rhythm in patients with various forms of supraventricular arrhythmia. By November 1997, the drug was being evaluated in clinical trials for its use in patients with implantable cardioverter defibrillators (ICDs). The study was to examine its ability to reduce the frequency and severity of ICD electrical discharges. As of August 1999, azimilide was in phase I development by Tanabe Seiyaku in Japan, for the potential treatment of arrhythmia. Results of a pivotal clinical trial, presented at the annual meeting of the Society for Neuroscience in November 1998, demonstrated azimilide to prolong the arrythmia-free period in patients suffering from atrial fibrillation. Phase III clinical trials so far have involved patients with supraventricular and ventricular arrhythmias. Trial results from the ASAP (Azimilide Supraventricular Arrhythmia Program Trial), showed that azimilide significantly prolonged the arrythmia-free period in patients suffering from atrial fibrillation. There were three deaths in the azimilide group compared to one in the placebo group. The safety and efficacy of azimilide in 6000 patients who have suffered a heart attack is currently under study in the phase III ALIVE (azimilide post-infarct survival evaluation) multicenter trial, which commenced in centers in the US and Europe in October 1997.