Reminyl impaired cognitive function?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
J&J's Alzheimer's agent Reminyl (galantamine) yielded a higher mortality rate versus placebo in two studies in mild cognitive impairment, prompting a review by FDA and foreign health authorities, J&J says Jan. 21. Of the approximately 2,000 patients in the GAL-INT-11 and GAL-INT-18 studies, "20 deaths due to various causes were reported during the double-blind portion of the two pivotal studies, with 15 occurring in subjects randomized to galantamine and five occurring in patients receiving placebo," the company reports. Neither trial showed efficacy in mild cognitive impairment - J&J is no longer pursuing an indication in the condition...