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SEROQUEL®: Further phase III trials to determine efficacy as new treatment for bipolar disorder

Added: (Thu Nov 16 2000)

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SEROQUEL®: Further phase III trials to determine efficacy as a new treatment for devastating symptoms of bipolar disorder

Alderley Park, UK. - 14 November, 2000 - AstraZeneca today announced the start of three phase III clinical trials to further determine the effectiveness of its atypical antipsychotic SEROQUEL (quetiapine) in the treatment of the symptoms of acute mania in patients with bipolar 1 disorder. The trials were prompted by recent encouraging data from existing trials which indicate that SEROQUEL is not only effective in alleviating psychotic symptoms, but also has beneficial effects on mood, aggression and hostility.1,2

The four double-blind, randomised trials, beginning now, will involve over 800 patients in 28 countries and will determine SEROQUEL’s efficacy and tolerability in a variety of clinical settings.

Trial 100 is evaluating SEROQUEL as an adjunctive treatment to a mood stabilising agent and involves 220 patients with acute manic episodes of bipolar disorder in over 30 centres across Western and Southern Europe, North America and Africa. Its sister trial, Trial 99, which is already underway will evaluate SEROQUEL with the same clinical criteria in the USA.

Beginning in November, Trial 104 will compare the efficacy of SEROQUEL and haloperidol as monotherapy in acute mania in bipolar 1 disorder compared to placebo. It will assess nearly 350 patients in 13 countries in Asia, Eastern Europe and South America. Trial 105 will compare SEROQUEL and lithium over placebo as monotherapy in the treatment of acute manic episodes in over 300 patients.

Dr Martin Brecher, Global Product Physician, AstraZeneca, described the rationale behind the commencement of these clinical trials. “Some patients with bipolar 1 disorder experience psychotic symptoms,” he commented. “SEROQUEL is already established as an effective and exceptionally well tolerated antipsychotic agent. Clinical experience has demonstrated that it works3 and patients report they prefer it to previous medication, which is reflected in the rapid increase we are seeing in clinical usage.”

“SEROQUEL helps relieve anxiety symptoms and also improves psychotic symptoms exemplified by suspiciousness, hallucinations and unusual thought content, within one week; all qualities which would be of particular benefit in bipolar disorder,” continued Dr Brecher. “We are optimistic that these trials will further confirm that SEROQUEL is effective in bipolar disorder without causing the debilitating side effects so often seen with current treatments.”

Bipolar disorder affects one to two per cent of the general population. Characterised by recurrent, cyclical episodes of depression and elevated mood, it is typically treated with a combination of mood stabilisers and conventional antipsychotics which are commonly associated with a range of debilitating side effects including movement disorders, weight gain and sexual dysfunction. SEROQUEL, already established as an efficacious and exceptionally well-tolerated treatment of schizophrenia, may provide a valuable new treatment option for people suffering bipolar disorder.

SEROQUEL (quetiapine) is manufactured by AstraZeneca and is currently approved in over 65 markets. SEROQUEL combines broad-based efficacy in the treatment of positive, negative, cognitive and affective symptoms of schizophrenia, while being well-tolerated. SEROQUEL is associated with an incidence of EPS and prolactin elevation no different to placebo even at highest recommended doses, a neutral effect on weight in long-term treatment, and no clinically important effects on electrocardiograms. To date, over 600,000 people have been treated with SEROQUEL world-wide.

AstraZeneca plc is a world-leading pharmaceutical business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals. It is one of the top five pharmaceutical companies in the world with leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is dedicated to providing innovative medicines for the treatment of diseases of the central nervous system (CNS) where there is a high unmet medical need. The company already markets drugs for the treatment of migraine (ZOMIG®) and schizophrenia (SEROQUEL®), and has an industry-leading R&D pipeline of several novel pharmacological approaches for the treatment of acute stroke, depression and anxiety and other key disease areas.

‘SEROQUEL’ is a trademark property of AstraZeneca.


For further information, please contact:

Antonia Betts or Oliver Rosenbauer, Shire Hall International
Tel. +44 (0) 207 471 1500
Email: antonia.betts@sh-international.com
Email: oliver.rosenbauer@sh-international.com

Or, for an electronic and downloadable version of this press release, please visit the psychiatry resource internet site at:

1Hellewell J, Cantillon M, McKellar M et al: ‘SEROQUEL’: efficacy in aggression, hostility and low mood of schizophrenia. Int J. Neuropsychopharmacol. (1999) 2 (Suppl. 1): S112.
2Kasper S, Mueller-Spahn F: Review of quetiapine and its clinical applications in schizophrenia. Exp. Opin. Pharmacother. (2000) 1(4):783-801.
3Zarate, C, et al: Clinical predictors of acute response with quetiapine in psychotic mood disorders. Poster presented at Annual ACN meeting, Acapulco, Mexico, December 1999.

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