US FDA approves GSK's Wellbutrin for SAD

18 June 2006

The US Food and Drug Adminsitration has approved UK drug major GlaxoSmithKline's Wellbutrin (bupropion extended release) for the treatment of seasonal affective disorder.

The agent, which is already cleared for the treatment of major depressive disorder, can now be used in the USA for this rare form of depression provoked by the decrease in daylight hours seen in the winter months and during the fall.

According to the London-headquartered pharmaceutical firm, which is the world's second-largest by sales, the drug's effectiveness in SAD has been shown in three double-blind, placebo-controlled trials in adults with a history of MDD in the fall and winter months, who started treatment before the onset of the core symptoms of MDD and gradually stopped using it by the spring. Across all three clinical evaluations, the overall rate of patients who were depression-free at the end of the treatment period was 83% for those on Wellbutrin versus 72% for the placebo group.

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