anxiety disorders, panic disorder, obsessive-compulsive disorder, phobias, post-traumatic stress disorder

The Food and Drug Administration (FDA) today approved Wellbutrin XL for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). This is the first drug approved for SAD. Wellbutrin XL (bupropion HCL extended release tablets) previously was approved for treatment of major depressive disorder.

The effectiveness of Wellbutrin XL for the prevention of SAD episodes was established in 3 double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter. Treatment was initiated prior to the onset of symptoms in the autumn (September to November) and was discontinued following a two-week taper that began the first week of spring (fourth week of March). In these trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo; for all 3 studies combined, the overall rate of patients depression-free at the end of treatment was 84 percent for those on Wellbutrin XL compared to 72 percent for those on placebo.

It is important to note that Wellbutrin XL is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes. Such patients have a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning. The clinician and patient should carefully assess the potential risks and benefits when considering treatment with Wellbutrin XL for SAD.

(Emphasis added, Ed.)

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