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Published on 6/12/2006 in the Prospect News Biotech Daily.

FDA approves Wellbutrin XL for prevention of seasonal major depressive episodes

By Lisa Kerner

Charlotte, N.C., June 12 - The Food and Drug Administration approved GlaxoSmithKline's Wellbutrin XL for the prevention of seasonal major depressive episodes in patients diagnosed with seasonal affective disorder (SAD), which affects about 6% of American adults.

Symptoms of SAD may include depressed mood, overeating (with carbohydrate cravings), weight gain, lethargy and increased sleep.

In a combined analysis of three clinical trials, Wellbutrin XL reduced the chance of developing a seasonal major depressive episode by 44%, according to a company news release

In the three studies, patients who enrolled suffered an average of 13 previous seasonal major depressive episodes. Of the 41% previously for this condition, 23% were treated with light therapy and 76% with antidepressants.

For all three studies combined, the depression-free rate at the end-of-treatment was 84.3% in the Wellbutrin XL group, and 72% in the placebo group.

GlaxoSmithKline is a research-based pharmaceutical and health care company headquartered in London.


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