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Janssen/Shire Reminyl

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Galantamine was shown to "significantly benefit the cognitive, functional and behavioral symptoms of AD" relative to placebo in a five-month study of 978 patients with mild to moderate Alzheimer's, Janssen investigators reported at the Sixth International Springfield Symposium in Stockholm, Sweden. The study randomized patients to placebo or one of three Reminyl dose regimens: 8 mg/day for the five-month period; 8 mg/day for four weeks followed by 16 mg/day for 17 weeks; and 8 mg/day for four weeks, followed by 16 mg/day for four weeks and 24 mg/day for 13 weeks. Most patients received concomitant medication. Efficacy measurements included the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog), the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus), the Alzheimer's Disease Cooperative Study Activities of Daily Living inventory (ADCS-ADL), and the Neuropsychiatric Inventory (NPI). The intent-to-treat analysis for ADAS-cog showed mean changes from baseline of 1.7 for placebo patients, 0.4 for 8 mg, and -1.4 for the 16 and 24 mg doses. Changes from baseline on the ADCS-ADL mean scores were -3.8 for placebo vs. -3.2 for 8 mg, -0.7 for 16 mg and -1.5 for 24 mg, investigators reported. The number of patients improving or showing no change on the CIBIC-plus measure was 49% for placebo, 53% for 8 mg, 66% for 16 mg, and 64% for 24 mg. The mean change from baseline for the NPI measure was 2.0 for placebo, 2.3 for 8 mg, -1.0 for 16 mg, and 0 for 24 mg. The study also showed that tolerability of galantamine is optimized by gradual dose escalation. Adverse events, which included nausea, anorexia, agitation and diarrhea, were mostly "mild and transient," according to an abstract. Janssen filed an NDA for galantamine in September 1999, and results from the 978-patient study were submitted as an NDA amendment in February

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