Source: Head & Neck  |  Posted 6 years ago

TORONTO, ON -- January 17, 2006 -- Biovail Corporation today announced that the Therapeutic Products Directorate Canada (TPD) has issued a Notice of Compliance (NOC) for 150 mg and 300 mg tablet strengths of Wellbutrin? XL, a once-daily, extended-release formulation of bupropion hydrochloride (HCl) for the treatment of major depressive illness in adults.

Upon launch, Wellbutrin? XL will be the first and only once-daily formulation of bupropion available in Canada.

Biovail Pharmaceuticals Canada (BPC), Biovail's Canadian sales and marketing division, will introduce the features and benefits of Wellbutrin? XL to health-care professionals throughout Canada. BPC anticipates launching Wellbutrin? XL late in the first quarter of 2006.

"Once-daily Wellbutrin? XL is an effective first-line treatment for depression with a low incidence of sexual dysfunction, weight gain, and somnolence," said Douglas Herman, Vice-President and General Manager of BPC. "This tolerability profile is important, given that drug-related side effects of anti-depressants are a major reason why treatment may be discontinued."

First-Line Efficacy with Excellent Tolerability Profile
Wellbutrin? XL is efficacious in the treatment of depression, and is recommended by Canadian depression guidelines for first-line use. It is unique among first-line anti-depressants due to its dual mode of action on norepinephrine and dopamine. As the only agent that does not affect serotonin, Wellbutrin? XL has a low risk of sexual dysfunction, weight gain, and somnolence.

Canadian Depression Market
Wellbutrin? XL will vie for a share of the C$760-million depression market in Canada. For the 12-month period ended November 30, 2005, bupropion SR prescriptions grew at more than twice the rate of the overall market.

Safety Precautions

As with all medications, patients who are prescribed Wellbutrin? XL may experience side effects, which are most likely to present shortly after the commencement of treatment. The most common side effects that occurred in three pivotal, controlled, clinical trials with Wellbutrin? XL (greater than or equal to 5%) were headache, dry mouth, nausea, constipation, insomnia, dizziness, diarrhea, anxiety and decreased appetite. Seizure is a rare but potentially serious side effect of anti-depressant agents, including bupropion. It can occur in approximately one in 1,000 patients.

About Depression
Depression affects an estimated 1.4 million Canadians at any given time and is responsible for over C$3 billion in direct medical costs. It is the second leading cause of long-term disability among workers.

About Wellbutrin? XL
Wellbutrin? XL is the first and only once-daily norepinephrine dopamine reuptake inhibitor for the treatment of depression in adults. The active ingredient in Wellbutrin? XL, bupropion, acts upon norepinephrine and dopamine, two chemicals in the brain believed to help regulate different aspects of mood, cognition, and behavior. Imbalances in these brain chemicals may be associated with depressed mood and other symptoms of depression. Bupropion has no clinically significant impact on serotonin.

Biovail developed the formulation for Wellbutrin? XL and in October 2001, entered into a distribution-and-supply agreement with GlaxoSmithKline for the United States and the rest of the world, excluding Canada. Since it was launched in the United States in September 2003, Wellbutrin? XL has become an established once-daily treatment for the symptomatic relief of depression.

Wellbutrin?, Wellbutrin? SR, and Wellbutrin? XL are trademarks of The GlaxoSmithKline Group of Companies, and are used by Biovail under license.

SOURCE: Biovail Corporation