FDA approves new labelling for Seroquel in bioplar mania

07/23/04

Alderley Park, UK — 23 July, 2004 -- AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved additional efficacy labelling information based on 12-week data for SEROQUEL (quetiapine), a psychotropic medication indicated for the treatment of acute manic episodes associated with bipolar I disorder. The data 1, part of the large scale effort to examine SEROQUEL's use in bipolar disorder, showed that after 12 weeks, approximately two-thirds of patients receiving SEROQUEL alone experienced significant improvement in manic symptoms and achieved remission .

SEROQUEL is the first medication in its class to include monotherapy safety and efficacy data for acute manic episodes associated with bipolar disorder extending beyond three weeks in its label.

"For patients with bipolar disorder and their clinicians, it's important to know that Seroquel is not only effective in reducing symptoms of acute mania the first few weeks, but is also effective in the subsequent ®continuation phase, when patients can still have significant symptoms and are still at risk for relapsing," said Jamie Mullen, MD, Senior Director of Clinical Research, AstraZeneca. "These data demonstrate that SEROQUEL treatment alone works early and continues to work through 12 weeks. For patients coping with this illness, this is good news."

SEROQUEL was originally approved by the FDA in January 2004 as a monotherapy and adjunct therapy with lithium or divalproex, for the short-term treatment of acute manic episodes associated with bipolar I disorder. This approval was based on efficacy results following three weeks of treatment. These trials showed SEROQUEL to be well-tolerated and effective in the treatment of manic episodes — excited mental states seen in bipolar disorder that are characterized by impulsive behaviour, racing thoughts, pressured speech, and decreased need for sleep. 1, 2.

SEROQUEL has received 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 cause of disability in the world.3,4,5,6 More than half of those with bipolar disorder stop taking their medication at some point during their illness, subjecting themselves to a high risk of relapse and an increased risk of suicide.7 A medication's overall efficacy and tolerability profile is therefore vital to helping patients comply with their medication.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies in the world with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIG, a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.

For more information, please visit http://www.astrazenecapressoffice.com.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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