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DuPONT ETHMOZINE (MORICIZINE) WILL BE AVAILABLE IN SEPTEMBER

Executive Summary

DuPONT ETHMOZINE (MORICIZINE) WILL BE AVAILABLE IN SEPTEMBER, the company announced at a June 26 press conference in Washington, D.C. Cost will be $2-$4 per day depending on the dose. The company described the price as competitive with other anti-arrhythmics. The drug will be available in 200, 250 and 300 mg tablets. Ethmozine was approved by FDA on June 19 with a "IB" review rating, indicating a new chemical entity with a modest therapeutic gain over existing therapies ("The Pink Sheet" June 25, T&G-1). According to Ethmozine's labeling, the drug "is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening." FDA's classification of Ethmozine may reflect a view of the drug's relative safety profile in comparison to other anti-arrhythmics. The drug has been categorized as a Class I anti-arrhythmic. It was noted at the press conference that it does not fit into the Class IC category, but that its does have properties of the IC, IA, and IB anti-arrhythmics. At the press briefing, an investigator in the ongoing Cardiac Arrhythmia Suppression Trial (CAST), Joel Morganroth, MD, University of Pennsylvania School of Medicine, said that "compared to the other eight anti-arrhythmic drugs that it shares the Class I use with, I think there's no question...that Ethmozine has a safety record and a safety database that distinguishes itself clearly." Morganroth noted that two IC anti-arrhythmics, Bristol-Myers' Enkaid and Riker's Tambocor, were removed from the CAST study because they showed a two- to three-fold increase in mortality versus placebo ("The Pink Sheet" May 1, 1989, p. 10). The objective of CAST is to determine whether reducing asymptomatic ventricular arrhythmias in post-heart attack patients will decrease the incidence of sudden cardiac death. Four other drugs, Morganroth said, "have data that make us suspicious that they are ...probably in the same category" as Enkaid and Tambocor, and the two others have "such a high discontinuation rate" that it's hard to collect long-term safety data. "Ethmozine distinguishes itself," Morganroth maintained, "by having an extremely low rate of [proarrhythmia] occurrence, about 3-4% in patients with life-threatening arrhythmias...compared to about 15% in patients who have other Class I drugs." Another advantage of Ethmozine therapy, Morganroth reported, is its effect in patients with poor heart function. "About half of the drugs available in Class I clearly...make heart function worsen, and make heart failure more likely." With Ethmozine, this adverse effect is "very uncommon" he said. Approved labeling notes that "in some cases worsened heart failure in patients with severe underlying heart disease has been attributed to Ethmozine." Another CAST investigator, Craig Pratt, MD, Baylor College of Medicine, reviewed Ethmozine's database relative to safety in congestive heart failure patients and "found it to be very well-tolerated in patients with congestive heart failure." Pratt added that after Enkaid and Tambocor were removed from the CAST, patients with poor ventricular function were enrolled in the ongoing study of Ethmozine. According to the investigators, the CAST study currently has 400 to 500 patients on Ethmozine and enrollment will continue until 1992 or 1993. Ethmozine is the first drug licensed to an American company from the Soviet government. Under the licensing agreement, the licensing agency of the Soviet government will receive a 4% royalty on worldwide sales. Along with an indication for treating life-threatening arrhythmias, DuPont had originally sought approval for Ethmozine in treating symptomatic ventricular arrhythmias. In light of the concerns about the anti-arrhythmic class raised by the CAST study, FDA reportedly wanted a mortality trial and documentation of symptomatic relief for the additional indication. The warning section of Ethmozine's labeling discusses the interim results of CAST, stating: "Considering the known proarrhythmic properties of Ethmozine and the lack of evidence of improved survival for any anti-arrhythmic drug in patients without life-threatening arrhythmias, it is prudent to reserve the use of Ethmozine, as well as other anti-arrhythmic agents, for patients with life-threatening ventricular arrhythmias." DuPont has just concluded a multicenter trial, involving 30 sites, comparing Ethmozine, Enkaid and placebo effects in about 200 post-myocardial infarction patients with symptomatic arrhythmias. The study results are being analyzed and DuPont said it may file for the symptomatic arrhythmia indication for Ethmozine. In light of the CAST study, labeling for Enkaid and Tambocor was changed to delete non-life-threatening arrhythmia indications.
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