Approved in 2006, rasagiline (Azilect), a selective irreversible MAO-B inhibitor, is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease as initial monotherapy and as adjunct therapy to levodopa.
Over the first 18 weeks of the postmarketing, randomized, double-blind study, those treated with rasagiline had a significantly greater change from the baseline in the total UPDRS score (a mean reduction of 2.4 vs. placebo), the primary endpoint. There were also significant improvements in UPDRS motor scores among those on rasagiline, but no significant differences between the two groups in UPDRS activities of daily living scores. The rates of adverse events and serious adverse events were similar between the two groups: Among those on rasagiline, the overall rate of adverse events was 64% (5% were serious), compared with 61% (3% serious) for the placebo group.
Dr. Olanow disclosed that he is a consultant for almost all manufacturers of drugs for PD, including Biotie Therapies, the manufacturer of tozadenant, which also supported the study. The droxidopa study was supported by Chelsea Therapeutics, the drug’s manufacturer. The ANDANTE study was supported by Teva Pharmaceuticals, the manufacturer of rasagiline.
* This article was revised on 3/15/13.