By FDA, [RxPG] 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.
SAD is characterized by recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter. The depressive episodes can last up to 6 months. Although patients with SAD may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the non-seasonal episodes during the individual's lifetime.
A major depressive episode is defined as the presence of 5 or more of the 9 core symptoms of major depression for at least 2 weeks. The symptoms include: depressed mood; loss of interest; weight loss (or other weight or appetite changes); insomnia or hypersomnia; agitation or psychomotor retardation; fatigue; feelings of worthlessness or guilt; impaired concentration; suicidal thinking or behavior. One of the 5 symptoms must be either depressed mood or loss of interest in activities. Another essential feature of major depression is the presence of significant distress or impairment in social, occupational, or other important areas of functioning. A seasonal major depressive episode is defined by the identical features.
Seasonal affective disorder can significantly impair the quality of life of patients with this condition, said Dr. Steven Galson, Director for FDAs Center of Drugs and Research. Todays approval can help patients with this condition to avoid the depressive symptoms and impaired functioning that typically affect them in the fall and winter.
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.
Wellbutrin XLs labeling includes a black box warning concerning the increased risk of suicidal thoughts and behavior in pediatric patients treated with antidepressant medications. As with all antidepressants, Wellbutrin XL has a Medication Guide (MedGuide, or patient labeling) advising that pediatric patients on antidepressants should be watched closely for these serious symptoms. Important side effects to watch for with Wellbutrin XL, especially shortly after the initiation of the treatment, include agitation, anxiety and insomnia. Wellbutrin was safe and well tolerated by patients in the SAD trials.
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.
Food and Drug Administration (FDA), USA
On the web:www.fda.gov
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