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Executive Summary

WARNER LAMBERT's COGNEX: FDA ADVISORY COMMITTEE UNABLE TO RECOMMEND APPROVAL due to unresolved questions regarding the efficacy of tacrine for the treatment of Alzheimer's disease. In a marathon March 15 session, FDA's Peripheral & CNS Drugs Advisory Committee adjourned at 10:15 p.m. without determining whether the sponsor's two pivotal trials established efficacy or were adequate and well-controlled." The committee did not move on to discuss tacrine safety or marketability issues. The committee could decide only that the dose-titration portion of Warner-Lambert's double-blind, placebo-controlled, multi-center study (protocol 970-1) showed some statistically significant "small effect" as measured by one objective efficacy assessment (the ADAS-Cognitive subscale). The committee found that the positive effect seen in the second pivotal trial, conducted by Shire Pharmaceutical, was "confounded" by complicating factors, including concomitant use with lecithin. Tacrine was studied under an expedited clinical trial protocol agreed to by FDA, Warner-Lambert and the National Institute of Aging. Calling the protocol "a gamble" because of the short-cuts is allowed, committee acting chairman Steven Ferris, PhD, New York University Medical Center, indicated that the committee would have been more persuaded by the data if it had shown "clean, clear-cut" evidence of substantial improvement in the assessments of cognitive function. Ronald Cresswell, PhD, Warner-Lambert Pharmaceutical Research Division VP and chairman, informed the advisory committee very late in the meeting that there are other tacrine trials ongoing and that his company will make the data available to FDA. He cautioned, however: "I don't see any likelihood" that this additional data will appear before a year to a year-and-a-half." In the meantime, Alzheimer's patients would be deprived of a therapy that did show some drug effect, Cresswell concluded. Ferris responded: "I don't think we should be influenced by what I would portray as an emotional side to this story," noting that the committee had to make a "considered judgment" based solely on the available evidence.

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