HDA approves ER Wellbutrin

The FDA has approved Wellbutrin XL (bupropion hydrochloride extended-release tablets), from Biovail Corporation from Bridgewater, NJ, US, for the treatment of major depressive disorder in patients 18 and older.

The company says 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 (GSK) will market Wellbutrin XL in the US and it is expected that the product will be available inpharmacies by mid-September.

'The convenience of a once-daily dosing of the well-known and trusted bupropion hydrochloride will be a welcome improvement for patients coping with depressive illness and for the physicians who are treating them,' commented Eugene Melnyk, Biovail's chairman and ceo. 'While Wellbutrin SR has been the number one prescribed antidepressant among US psychiatrists, we know that the twice-daily dosing could be a major prescribing barrier for many physicians. In addition to the once-daily dosing, the low risk of sexual side effects and weight gain make Wellbutrin XL a very attractive option for patients with these concerns.'

Depressive illness affects approximately 14m adults in the U.S. or 6.6% of the population in a given year. In the U.S. there is more than a 16% chance for an adult to develop major depressive disorder in his or her lifetime. Nearly two-thirds of people fail to get help for their depression, yet treatment can alleviate symptoms in more than 80% of cases.

Wellbutrin XL tablets have a two-layer coating de-signed to release drug slowly in the body. Biovail li-censed this once-daily formulation of bupropion hy-drochloride to GSK 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.

How Wellbutrin works

Wellbutrin XL is the first and only once-daily norepinephrine dopamine reuptake inhibitor (NDRI) for the treatment of depression in adults. The active ingredient in Wellbutrin XL, bupropion hydrochloride, is believed to act upon norepinephrine and dopamine, two chemicals in the brain known to help regulate different aspects of mood, cognition, and behaviour. Imbalances in these brain chemicals are associated with depressed mood and other symptoms of depression. Bupropion has no clinically significant impact on serotonin, a third brain chemical involved in mood regulation.