Emsam

Selegiline transdermal patch
BRISTOL-MYERS SQUIBB/SOMERSETMAO inhibitor approved in a transdermal patch formulation

Selegiline is an irreversible inhibitor of monoamine oxidase (MAO) whose mechanism of action in the treatment of depression is not fully understood. The selegiline transdermal patch was approved for the treatment of major depressive disorder (MDD) on February 28, 2006.

Efficacy. The efficacy of the selegiline transdermal patch was evaluated in 2 placebo-controlled studies of 6 and 8 weeks duration in adult outpatients (N=441) with MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). The 6-week trial demonstrated that the selegiline transdermal patch (6 mg/24 h) was significantly more effective than placebo on the 17-item Hamilton Depression Rating Scale (HAM-D). In the 8-week dose titration trial, patients receiving selegiline at a rate of 6 mg/24 h, with possible increases to 9 mg/24 h or 12 mg/24 h based on clinical response, demonstrated significant improvement compared with placebo on the primary outcome measure, the 28-item HAM-D total score. In a continuation trial, 322 patients who had responded to the selegiline transdermal patch during an initial 10-week, open-label treatment phase for approximately 25 days were randomized to continuation of selegiline via transdermal patch at the same dose or to placebo for observation of relapse. Relapse was defined as follows: a 17-item HAM-D score ≥14; a Clinician's Global Impressions Improvement Scale (CGI-S) score of ≥3 (with at least a 2-point increase from double-blind baseline); and meeting DSM-IV criteria for MDD on 2 consecutive visits ≥11 days apart. Patients receiving selegiline via the transdermal patch experienced a significantly longer time to relapse than did those receiving placebo during the double-blind phase of the trial.

Dosing. The selegiline transdermal patch should be applied to dry, intact skin on the upper torso, upper thigh, or the outer surface of the upper arm once every 24 hours. The recommended starting and target dose for selegiline delivered via transdermal patch is 6 mg/24 h. Dose increases can be made based on clinical judgment in increments of 3 mg/24 h up to a maximum dose of 12 mg/24 h. Patient should be informed that tyramine-rich foods and beverages should be avoided beginning on the first day of selegiline 9 mg/24 h or 12 mg/24 h treatment and should continue to be avoided for 2 weeks after a dose reduction to selegiline 6 mg/24 h or discontinuation of the higher doses.