Astrazeneca Submits Supplemental New Drug Applications For Seroquel XR For The Treatment Of Bipolar Mania And Bipolar Depression
The bipolar mania submission is based on a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) total score (week 3), in 316 patients suffering from bipolar mania. The bipolar depression submission is supported by a clinical study of once-daily treatment with SEROQUEL XR, compared to placebo, with a primary endpoint of change from baseline in MADRS (Montgomery Asberg Depression Rating Scale) total score after 8 weeks of treatment, in 280 patients diagnosed with bipolar depression. 1 Doses of SEROQUEL XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression (300 mg/day) studies were comparable to the FDA-approved recommended doses for SEROQUEL (quetiapine fumarate) immediate release tablets in those indications.1,2 Both studies met their primary endpoint and it is expected that they will be presented at major scientific congresses in 2008.
SEROQUEL XR is currently approved in 8 countries including US, Canada and The Netherlands, for the acute and maintenance treatment of schizophrenia in adults.
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 25 million patients worldwide*. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the USA for the treatment of bipolar depression. SEROQUEL XR was launched for the treatment of schizophrenia in the US in 2007, and its clinical development program and planned regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalized anxiety disorder (GAD).
About AstraZeneca
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 with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
*Estimate based upon: (1) assumptions as to persistence (the number of prescriptions per patient) based upon 2002 market research; and (2) projections of prescriptions since launch based upon information available in the US and 13 of the 50 other countries in which SEROQUEL is marketed.
References
1. Data on file, (US) DA-SXR-11.
2. SEROQUEL® (quetiapine fumarate) Prescribing Information.
http://www.astrazeneca.com
View drug information on Seroquel.
AstraZeneca Prezintã suplimentare New Drug Cererile pentru Seroquel XR pentru tratamentul bipolarã Mania ªi bipolarã Depresie - Astrazeneca Submits Supplemental New Drug Applications For Seroquel XR For The Treatment Of Bipolar Mania And Bipolar Depression - articole medicale engleza - startsanatate