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Higher Relative Mortality Rate Seen in Studies Involving Galantamine Hydrobromide
REMINYL® is an acetylcholinesterase inhibitor currently approved in 69 countries worldwide for treatment of mild to moderate Alzheimer's disease. No regulatory applications have been submitted for the potential use of REMINYL® for the treatment of mild cognitive impairment anywhere in the world, nor are any planned.
The review was initiated as a result of a preliminary safety assessment of an imbalance of mortality in two mild cognitive impairment clinical trials submitted to health authorities worldwide by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., in August 2004. The clinical trial results also were presented last year at two international scientific forums: the International Congress of Alzheimer's Disease (ICAD) and the Alzheimer's Association Research Roundtable Mild Cognitive Impairment Meeting. Johnson & Johnson Pharmaceutical Research & Development, L.L.C., has posted these results to the PhRMA clinical trials Web site, www.clinicalstudyresults.org.
Approximately 2,000 patients from 16 countries were enrolled in the GAL-INT-11 and GAL-INT-18 studies, which were designed to evaluate a potential decrease in the rate of progression from mild cognitive impairment to dementia in subjects treated with the drug.
Mortality rates were low in both the REMINYL® and placebo groups in this two-year study compared to expected rates in this population or in patients with Alzheimer's disease. The clinical trials showed a higher relative mortality rate in patients with mild cognitive impairment treated with REMINYL® than in patients treated with placebo. In the 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 overall incidence of serious adverse events was not different between the group treated with REMINYL® and the placebo-treated group.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., is currently analyzing additional data from these studies, including information retrieved from subjects who had dropped out of the trials, and is discussing the results with regulatory authorities.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., developed REMINYL® under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. Janssen Pharmaceutica Products, L.P., manufactures and markets REMINYL® in the U.S.
REMINYL® is approved to treat patients with mild to moderate dementia of Alzheimer's. The most frequent adverse events are nausea, vomiting, diarrhea, anorexia and weight loss. They are usually mild and temporary. Please see www.reminyl.com for full prescribing information.
Source: Johnson and Johnson