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FDA Approves Wellbutrin XL -- New, Once-Daily Antidepressant with Low Risk of Sexual Side Effects and Weight Gain
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Aug. 29, 2003--
New Medication to Provide Important Treatment Option
for Adults with Depression
Biovail Corporation (NYSE:BVF) (TSX:BVF) announced today that the U.S. Food and Drug Administration (FDA) has approved Wellbutrin XL(TM) (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 (GSK) will market Wellbutrin XL in the United States and it is expected that the product will be available in pharmacies by mid-September. "The convenience of a once-daily dosing of the well-known and well 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 Chief Executive Officer. "While Wellbutrin SR(R) has been the number one prescribed antidepressant among U.S. 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 14 million adults in the U.S. or 6.6 percent of the population in a given year. In the U.S. there is more than a 16 percent 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 percent of cases. Wellbutrin XL tablets have a two-layer coating designed to release drug slowly in the body. Biovail licensed this once-daily formulation of bupropion hydrochloride 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 XL 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 behavior. 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. CLINICAL HIGHLIGHTS The approval of Wellbutrin XL was based on bioequivalence to Wellbutrin(R) Tablets (the immediate-release formulation of bupropion). Wellbutrin XL has also been proven bioequivalent to Wellbutrin SR(R) Tablets (the sustained-release formulation of bupropion). The efficacy of bupropion in the treatment of a major depressive episode was established using the immediate-release formulation in two four-week controlled trials of inpatients 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(R)(a) in treating moderate to severe recurrent major depression. SAFETY INFORMATION Wellbutrin XL has been proven bioequivalent to both Wellbutrin(R) Tablets and Wellbutrin SR(R) 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(R) (bupropion hydrochloride) Sustained-Release Tablets or Wellbutrin SR(R) 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(TM) 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 demonstrated bioequivalence to both. At doses of up to 300 mg/day of the sustained-release formulation (Wellbutrin SR(R)), the incidence of seizure is approximately 0.1 percent. At doses of 300 mg/day to 450 mg/day of the immediate-release (Wellbutrin), the incidence of seizure is approximately 0.4 percent. To reduce the risk of seizures, refer to the Warnings section of the Prescribing Information for patient selection considerations, including concomitant medications and dosing recommendations. The weight loss potential of Wellbutrin XL should be considered if weight loss is a major presenting sign of the depressive illness. When treating patients with severe hepatic cirrhosis, extreme caution should be exercised and a reduced dosage and/or frequency is required to avoid accumulation. (a) Zoloft (sertraline HCl) is a registered trademark of Pfizer Inc. Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies. For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com. "Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission.
CONTACT: Biovail Corporation
Ken Howling, 905-286-3000
SOURCE: Biovail Corporation
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