AstraZeneca Presents New Depression And Anxiety Results For SEROQUEL XR

The early follow-up from the SEROQUEL XRâ (quetiapine fumarate) Extended Release clinical perfection memo within trunk depressive mess up (MDD)1,2 and generalised anxiety disorder (GAD)3 be presented at the 7th International Forum antagonistic Mood and Anxiety Disorders (IFMAD) in Budapest, AstraZeneca announced today. The data put on view that patients who received SEROQUEL XR once day by day sophisticated of the archetype reduction in symptom dourness compare to those on placebo in respectively of three trial, which follow a line of investigation SEROQUEL XR in place of monotherapy in MDD,1 adjunctive analysis in patients close at hand MDD2 with not up to standard retort to antidepressant therapy, and as monotherapy in GAD.3 These study be limb of a clinical development programme that entangled done 7000 patients - one of the largest conduct in deflation and anxiety. SEROQUELÂ and SEROQUEL XRâ are not voted for in reinforcement of the nursing of MDD or GAD.

Reductions in symptom severity were measured with enhanced (lowered) symptom size score. Two randomised, double-blind Phase III studies in MDD report substantially reduced uncorrupted scores on the Montgomery-Ãsberg Depression Rating Scale (MADRS) after 6 weeks of treatment with once daily SEROQUEL XR. In the MDD monotherapy become skilled at, propose MADRS chalk up be significantly improved for patients reception SEROQUEL XR 150 mg (-14.81; p0.001) and 300 mg ( 15.29; p0.001) compared with placebo (-11.18). When given as adjunctive therapy in MDD to patients who were experiencing an inadequate response to their widespread antidepressant treatment, mean MADRS score was significantly improved for patients receiving SEROQUEL XR 150 mg (-15.26; p0.01) and 300 mg ( 14.94; p0.01) compared with antidepressant alone (-12.21). In a third study examining patients with GAD, mean Hamilton Anxiety scale (HAM-A) score was significantly improved after 8 weeks of monotherapy for patients receiving SEROQUEL XR 50 mg ( 13.95; p0.05) and 150 mg ( 15.96, p0.001) compared with placebo ( 12.30).

Dr Stuart Montgomery, Imperial College School of Medicine, University of London and critic of the MDD monotherapy study said: "These study grades are outstanding - all of the dose of SEROQUEL XR consider provide improvements in MDD and GAD symptom. Results from further studies that are gradually ongoing will attach to our fluency of SEROQUEL XR in these provisions." In all three studies presented at IFMAD, SEROQUEL XR was collectively all apposite tolerate. The crag widespread adverse actions across all of the doses examined (50-300 mg/day) were shrunken maw (15.9-38.2%), sedation or fatigue (13.2-38.8%), somnolence (16.8-27%) and light-headedness (9.2-19.1%). The numbers of patients with blood glucose elevated above 126 mg/dL at study close up for SEROQUEL XR 150 mg, 300 mg and placebo, respectively, were 2.9%, 6.3% and 0.9% in the MDD monotherapy and 3.2%, 6.3% and 3.3% in the adjunctive therapy study. In the GAD study the elevation was see in 1.1% of patients (50mg SEROQUEL XR), 0.6% (150mg SEROQUEL XR) and 1.7% (placebo).

Martin Brecher, Executive Director Medical Science, AstraZeneca said: "The data are deeply encouraging and recommend SEROQUEL XR have the eventual to furnish a alien treatment decision here municipality above all among patients who wake up amiss antidepressant therapy with present treatment. The study program not freshly cover adjunct treatment but stretched also to monotherapy. New therapy opportunity are needed for immoderation MDD and GAD because right now accessible antidepressants pull off not achieve symptom remission in a great percentage of patients. Over the coming months and years we will swot more something like how far an antipsychotic close to SEROQUEL XR may provide a new option for these patients. AstraZeneca strategy regulatory submission in 2008." Recently presented data may abet to hone the study data in MDD and GAD alongside SEROQUEL's pushy efficacy in bipolar depression. A pre-clinical study previously own intelligence imaging with positron secretion tomography (PET) to investigate the machinery of besiege of SEROQUELÂ in non-human primates.4 SEROQUEL (quetiapine fumarate), both head-on and askance (via its major helpful metabolite norquetiapine), was found to target the dopamine D2 and the serotonin 5-HT2A receptors in the brain at blood concentration akin to those during treatment with clinically recommended doses of SEROQUEL in human. Additionally, SEROQUEL's major active metabolite norquetiapine was shown to target NET - the carter for norepinephrine (noradrenaline).

Inhibition of NET elevate norepinephrine (noradrenaline) level in specific area of the brain, an effect that be associated with antidepressant action.

Launched in 1997, it is ballpark that SEROQUEL has be prescribed to better than 25 million* patients international. It is approved in 88 country for the treatment of schizophrenia, in 77 countries for the treatment of bipolar thing, and in 11 countries together with the USA for the treatment of bipolar depression. SEROQUEL XR was launch for the treatment of schizophrenia in the US in 2007, and its clinical development program and premeditated regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalised anxiety disorder (GAD).

AstraZeneca is a major multinational healthcare conglomerate busy in the research, development, meeting and marketing of prescription pharmaceuticals and the deliver of healthcare services. It is one of the world's supreme pharmaceutical company with healthcare dutch auction of $26.47 billion and leading situation in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and pollution products. AstraZeneca is nominated in the Dow Jones Sustainability Index (Global) moreover as the FTSE4Good Index.

SEROQUEL XRâ and SEROQUELÂ are trademark of the AstraZeneca show of companies.

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Presented at the International Forum on Mood and Anxiety Disorders, Budapest, Hungary, 5-7 December, 2007 4. Nyberg S et al. PET-measured D2, 5-HT2, and NET leasing by quetiapine and N-desalkyl-quetiapine in non-human primates. Presented at the European Congress of Neuropsychopharmacology, Vienna, Austria, 13-17 October, 2007 *This rough calculation is base upon: (1) assumption as to pushiness (the digit of prescription per patient) based upon 2002 open market research; and (2) projection of prescriptions since launch based upon numbers available in the US and 13 of the 50 other countries where SEROQUEL is market.

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