ROCKVILLE, Md. - The FDA today approved Wellbutrin XL (bupropion extended release) for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). It is the first drug approved for SAD.
ROCKVILLE, Md., June 12 - The FDA today approved Wellbutrin XL (bupropion extended release) for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). It was the first drug approved for SAD.
The agency emphasized that Wellbutrin XL, manufactured by GlaxoSmithKline, "is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes." It characterized such patients as those who have "a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning."
Patients diagnosed with SAD have recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter. Wellbutrin XL previously was approved for treatment of major depressive disorder.
Depressive episodes in SAD, said the FDA, are defined as depression characterized by the presence of five symptoms such as depressed mood, weight loss or appetite changes, insomnia or hypersomnia, loss of interest in activities, agitation, fatigue, suicidal think or behavior, and feelings of worthlessness or guilt lasting for at least two weeks. These episodes can, however, last as long as six 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, said the agency.
Steven Galson, M.D., director of the FDA's Center of Drugs and Research, said SAD is typically associated with significant impairment. "Today's approval can help patients with this condition to avoid the depressive symptoms and impaired functioning that typically affect them in the fall and winter," he said.
For the effectiveness of Wellbutrin XL for the prevention of SAD episodes, the FDA cited three 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 in the first week of spring. In these trials, the percentage of depression-free patients at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo. For the three studies combined, the overall rate of depression-free patients at the end of treatment was 84% for those taking Wellbutrin XL, which was 12% better than patients randomized to placebo.
The FDA also noted that Wellbutrin XL's 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 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, the FDA said. Wellbutrin was safe and well tolerated by patients in the SAD trials.