GlaxoSmithKline’s Wellbutrin XL gets “exciting” approval for SAD

GlaxoSmithKline has received approval from the FDA to use Wellbutrin XL (also sold as Zyban) in cases of seasonal affective disorder (SAD), a type of winter depression.

After three studies, Glaxo concluded that Wellbutrin XL reduces the chance of developing a “seasonal major depressive disorder episode” by 44 per cent. The average patient in the study had an average of 13 previous seasonal major depressive episodes, although only 41 per cent had received treatment before. Over half said that SAD was a “severe problem”.

The depression-free rate for Wellbutrin XL was found to be 84.3 per cent for all three studies combined, in comparison with 72 per cent for the placebo. Additionally, the drug was found to be tolerated in a consistent manner with previous trials for the drug – the most common side effects were dry mouth, nausea, constipation and flatulence. In some cases with high doses, the risk of seizure increases.

Norman E Rosenthal, clinical professor of psychiatry at Georgetown Medical School, stated: “Seasonal affective disorder is a serious and often under-diagnosed form of depression that affects millions of people each year in the United States.

“The FDA approval of Wellbutrin XL for the prevention of seasonal major depressive episodes in adults diagnosed with SAD is exciting.”

“For the first time, it may be possible to prevent the predictable onset of SAD with medication by beginning treatment in the autumn season, prior to experiencing depressive symptoms,” he concluded.

Wellbutrin is not sold as an antidepressant in the UK after it was withdrawn due to the risk of seizures with high doses – one reason why the drug is sold in extended release form now in the US.

It is, however, sold in the UK under the name Zyban as a smoking cessation aid.

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