FDA Approves First Drug for SAD – Wellbutrin XL Approved for Seasonal Affective Disorder
June 12, 2006 — The FDA has approved the first drug to treat seasonal affective depression (SAD), a form of depression that strikes during the year’s darker seasons (autumn and winter).
The drug is Wellbutrin XL (bupropion HCL extended-release tablets), which is already approved to treat major depressive disorder.
“Seasonal affective disorder can significantly impair the quality of life of patients with this condition,” says the FDA’s Steven Galson, MD, MPH, in an FDA news release. Galson directs the FDA’s Center of Drugs and Research.
“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,” Galson says.
SAD is characterized by recurrent episodes of major depression that usually coincide with the seasonal decrease of daylight during autumn and winter. The depressive episodes can last up to six months.
SAD patients may have depressive episodes during other times of the year. But the SAD diagnosis requires that the number of seasonal episodes substantially outnumber the nonseasonal episodes during the individual’s lifetime.
Symptoms of major depression include depressed mood, loss of interest, changes in weight and appetite, changes in sleep (sleeping too much or too little), agitation or sluggishness, fatigue, feeling worthless or guilty, impaired concentration, and suicidal thinking/behavior.
SAD shares those symptoms.
Drug’s SAD Studies
Wellbutrin XL’s effectiveness in preventing SAD episodes was established in three trials of adults with a history of major depressive disorder in autumn and winter.
Patients either took Wellbutrin XL or a pill containing no medicine (placebo). They didn’t know which was which.
Treatment began before the onset of symptoms in the autumn (September to November) and stopped after tapering patients off the drugs for two weeks starting in the first week of spring.
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 three studies combined, the overall rate of patients depression-free at the end of treatment was 84% for those on Wellbutrin XL compared with 72% for those on placebo, according to the FDA.
‘Black Box’ Warning
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. A “black box” warning is the FDA’s strongest warning.
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 XL 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, states the FDA. Such patients have a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning.
Doctors and patients should carefully assess the potential risks and benefits when considering treatment with Wellbutrin XL for SAD, states the FDA.
Wellbutrin XL is made by GlaxoSmithKline, a WebMD sponsor.
By Miranda Hitti
Reviewed by Louise Chang, MD
SOURCE: News release, FDA.
© 2006 WebMD, Inc.