GlaxoSmithKline announced that the U.S. Food and Drug Administration has approved Wellbutrin XL (bupropion hydrochloride extended-release tablets) for the treatment of major depressive disorder in patients 18 and older. The new once-daily medication will offer patients an effective and convenient option to treat their depression, with a low risk of sexual side effects and weight gain. Sexual function and weight change are important considerations in selecting antidepressant therapy, as they may be a side effect of the medication or a symptom of the depression itself. GlaxoSmithKline expects Wellbutrin XL to be available in pharmacies by mid-September.
"Approximately 14 million adults in the U.S. suffer from depression, and while the number of available treatments has increased in the past decade, some antidepressant medications have left patients coping with other problems, such as side effects, which may include sexual dysfunction and weight change," said Anita Clayton, Professor of Psychiatry at the University of Virginia Health System. "Wellbutrin XL is a long-awaited treatment option because it offers a low risk of sexual side effects and weight gain – with the convenience of once-daily dosing."
Wellbutrin XL tablets have a two-layered coating designed to release drug slowly in the body. GlaxoSmithKline licensed this once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001. Wellbutrin XL will be available in two strengths, 150 mg and 300 mg, to allow for dosing flexibility. The usual target dose is 300 mg given once daily -- initiated at 150 mg/day and then increased to 300 mg/day as early as day four, if adequately tolerated. The maximum total daily dose of Wellbutrin XL is 450 mg.