Valeant announced that the FDA has approved Aplenzin (bupropion HBr) extended-release tablets for the prevention of seasonal major depressive episodes in patients with seasonal affective disorder (SAD).

The approval is based on efficacy results from three randomized, double-blind, placebo-controlled trials in adult outpatients with a history of major depressive disorder (MDD) with autumn-winter seasonal pattern (as defined by DSM-IV criteria). Results showed that the percentage of patients who were depression-free at the end of treatment was significantly higher in the bupropion group than in the placebo group (81.4% vs. 69.7%, 87.2% vs. 78.7%, and 84.0% vs. 69.0% for Trials 1, 2, and 3, respectively). For the three trials combined, the depression-free rate was 84.3% vs. 72.0% in the bupropion and placebo group, respectively.

Aplenzin is already indicated for the treatment for major depressive disorder.

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