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Health Canada Approves New Treatment for Bipolar Mania
MISSISSAUGA, Ontario -- June 7, 2008 – Health Canada has approved quetiapine fumarate extended-release tablets (seroquel xr) for the acute management of manic episodes associated with bipolar disorder. Quetiapine fumarate was found to improve core symptoms of mania, including irritability, speech, and thought content, compared with placebo.
"Compliance is a major issue for people with this condition. It is therefore important to provide patients with an effective and easy to use treatment that controls the symptoms with minimal side effects," said Roger McIntyre, MD, University of Toronto, Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, Canada. "With the approval of [quetiapine fumarate], bipolar mania patients will now have better symptom control, allowing for improved balance and stability in their daily lives with less chance of relapse occurring," he continued.
The efficacy of quetiapine fumarate in the management of manic episodes associated with bipolar disorder was established in a 3-week, placebo-controlled trial involving 316 bipolar patients with manic or mixed episodes with or without psychotic features. Patients randomised to quetiapine fumarate received 300 mg on day 1 and 600 mg on day 2. Afterwards, the dose could be adjusted between 400 mg to 800 mg once daily.
Quetiapine fumarate at a dose of 400 to 800 mg/day for 3 weeks demonstrated a statistically significant reduction compared with placebo in the level of manic symptoms as early as day 4 and throughout the 3 weeks of treatment, as measured by the Young Mania Rating Scale (YMRS).
The core manic symptoms including irritability, speech, and thought content were improved in patients taking 400 to 800 mg/day of quetiapine fumarate. This improvement was found to be statistically significant compared with placebo as measured by the YMRS. In addition, patients taking quetiapine fumarate found improvements in depressive symptoms as early as day 4 as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
During acute therapy with quetiapine fumarate, the most commonly observed adverse events were sedation, dry mouth, somnolence, constipation, dizziness, and weight gain.
SOURCE: AstraZeneca
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