If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Europe Approves Seroquel (Quetiapine) for Treatment of Bipolar Mania SODERTALJE, SWEDEN -- October 14, 2003 -- AstraZeneca announced yesterday that it has successfully completed the Mutual Recognition Procedure (MRP) involving 14 European countries to extend the use of SEROQUEL (quetiapine) to the treatment of mania associated with bipolar disorder (manic-depressive illness). SEROQUEL is also under review for bipolar mania in the United States with the FDA and in the UK with the MHRA. "This approval is great news for clinicians involved in the treatment of bipolar disorder," commented Dr. Eduard Vieta, Director of Research, Department of Psychiatry, University of Barcelona. "The results from the clinical trial programme confirm that Seroquel holds real benefits for clinicians looking to treat the symptoms of the disease while keeping side effects to a minimum. This is of particular importance when treating patients with bipolar disorder since they can be particularly sensitive to treatment side effects which can in turn have a negative impact on compliance with medication." 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.(1,2,3,4) 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.(5) This lack of compliance is strongly associated with the occurrence of side effects, therefore, a well tolerated and effective treatment is pivotal to the successful treatment of this condition. Health authorities involved in the Mutual Recognition Procedure reviewed data from a comprehensive clinical trial programme in bipolar disorder undertaken by AstraZeneca, involving almost 1000 patients in 28 countries. The trials have delivered compelling results which confirm SEROQUEL to be an excellent first line therapy for the treatment of manic episodes associated with bipolar disorder. Individual licenses in the 14 European countries involved in the MRP will follow from the completion of this procedure. Health Authority approvals have also been received in Mexico and New Zealand. "We believe that SEROQUEL is an outstanding treatment which has benefited many patients who suffer from schizophrenia - and we are committed to further developing the product in the future," commented Geoff Birkett, Vice President, Global Marketing Neuroscience, AstraZeneca. "Our belief is that the clinical profile of SEROQUEL in bipolar mania is extremely well suited to this new patient group who place high demands on their therapy and need a balance of strong efficacy with enhanced tolerability. We have very high expectations for SEROQUEL as we launch into this competitive market and have set our sights on raising treatment standards in the area." References: (1) American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385, 395. (2) Hirschfield et al. J Clin Psychiatry. 2003;64:53-59 (3) Lisd JD, Dime-Meenan S, Whybrow PC et al. The National Depressive and Manic-Depressive Association (DMDA) survey of bipolar members. J Affect Disord. 1994;31:281-294. (4) World Health Organization and the World Bank. The Global Burden of Disease: Summary. Cambridge, Mass: The Harvard School of Public Health Harvard University Press, 1996. (5) Miklowitz D. The Bipolar Disorder Survival Guide. New York: The Guilford Press, 2002.
SOURCE: AstraZeneca
|
