FDA approves Wellbutrin XL(TM)( patients and one six-week controlled tr...),Health

patients and one six-week controlled trial of outpatients who met criteria for major depression. The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks was established with the sustained-release formulation in a placebo-controlled trial. Bupropion has also been shown to be effective in preventing relapse of depression. In other clinical studies, the active ingredient in Wellbutrin XL has proven comparable to Zoloft* in treating moderate to severe recurrent major depression.

SAFETY INFORMATION

Wellbutrin XL has been proven bioequivalent to both Wellbutrin Tablets and Wellbutrin SR tablets. Given that there are multiple formulations of bupropion, familiarity with the different names and dosing schedules is important to avoid dosing errors.

Placebo-controlled trials of Wellbutrin SR show it to be generally well tolerated. Adverse events reported in at least 10 percent of patients treated with Wellbutrin SR 300 mg/day or 400 mg/day and at a rate at least twice that of placebo were dry mouth, nausea, insomnia, dizziness, weight loss, and pharyngitis. Similar adverse events would be expected with Wellbutrin XL.

Wellbutrin XL is contraindicated in patients who have or have had a seizure disorder, patients being treated with Zyban (bupropion hydrochloride) Sustained-Release Tablets or Wellbutrin SR or any other medications that contain bupropion, patients who have or had bulimia or anorexia nervosa, patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines), and patients taking monoamine oxidase (MAO) inhibitors.

In treating depression, physicians should be aware that Wellbutrin XL is associated with a risk of seizures which is dose-related. While Wellbutrin XL has not been formally evaluated in clinical trials, its incidence of seizure may be similar to that of the immediate-release and the sustained-release formulations of bupropion, since it has demonst
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Contact: Holly Russell
919-483-2839
Cooney Waters Group, Inc.
29-Aug-2003

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