FDA approves new labelling for Seroquel in bio...( licences for the treatment of mania as...),Health

licences for the treatment of mania associated with bipolar disorder in 42 countries, including the US. SEROQUEL has also been licensed for the treatment of schizophrenia since 1997, and is available in 81 countries for the treatment of this condition. SEROQUEL is the fastest growing product among the three leading brands in the atypical antipsychotic market. Sales during 2003 reached $1.5 billion and the product currently ranks second in the US antipsychotic market for new and total prescription share, having recently overtaken olanzapine.

The new label information is supported by data from two, 12-week, double-blind, randomised, placebo-controlled trials assessing the safety and efficacy of SEROQUEL monotherapy for the treatment of manic episodes in a large cohort of adults with bipolar I disorder. A total of 599 patients experiencing a manic episode were assigned to receive SEROQUEL (from 200 mg/day up to 800 mg/day), placebo, or an active control (lithium or haloperidol). The primary endpoint was change from baseline YMRS (Young Mania Rate Scales) total score at day 21 of treatment (week 3); secondary endpoints included change from baseline YMRS total score at day 84 (week 12).1 The combined analysis of two 12-week, monotherapy, double-blind, placebo-controlled trials showed that:

• After 12 weeks, 66.8% of SEROQUEL-treated patients achieved a response (defined as 50% decrease from baseline YMRS score) versus 40.0% of the placebo group (p<0.001).

• After 12 weeks, 65.4% of SEROQUEL-treated patients achieved remission (defined as YMRS 12), versus 35.9% with placebo (p<0.001).

• Improvement in manic symptoms based on change in YMRS score in patients treated with SEROQUEL was significantly greater than placebo-treated patients, as early as day 4 onwards (p=0.02).

Bipolar disorder is a serious mental illness that affects approximately 3-4% of the adult population and is the sixth leading
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Contact: Rupert Doggett
rupert.doggett@shirehealthinternational.com
44-207-471-1512
Shire Health International
23-Jul-2004

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