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Executive Summary

Nicardipine's anti-anginal efficacy must be established beyond four hours before the calcium channel blocker can be considered for approval, FDA's Cardiorenal Drugs Advisory Committee unanimously agreed at its September 30 meeting. Committee Chairman Jeffrey Borer, MD, Cornell Medical Center said the committee cannot recommend approval of nicardipine for treatment of angina "because there are data missing." The committee agreed that the syntex had established a relationship between dose and peak effect. However, the committee felt the company had not established a relationship between dose and duration of effect. "There is a big hole between four and eight hours in the data," committee member Carl Leier, MD, Ohio State University Medical School, stated. FDA Cardio-Renal Drug Division Director Raymond Lipicky, MD, concurred: "I don't disagree at all that one was able to distinguish nicardipine from placebo, but as best as one can tell from the data, that efficacy lasts for four hours." Another problem centered on the committee's perception that the Syntex studies did not show a mechanism of action for nicardipine. "These data are interesting," Borer stated, "but I don't think they define a mechanism for preventing ischemia on the basis of improved myocardial profusion." Borer continued: "You haven't demonstrated the mechanism that you suggested in this data and therefore there are certain conclusions that we might want to make about how this drug could be used but we can't." Syntex filed a nicardipine NDA for angina in 1985, and said it plans to file an NDA for hypertension before the end of 1986. Licensed from the Japanese firm Yamanouchi, the calcium channel blocker will be marketed under the brand name Cardene. Syntex has sublicensing agreements for injectable and long-acting forms of the drug with American Critical Care (DuPont) and Key (Schering-Plough) respectively.

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