AstraZeneca Announces First Presentation Of Pivotal SEROQUEL XR(TM) Bipolar Studies

Main Category: Bipolar
Also Included In: Psychology / Psychiatry;  Mental Health;  Depression
Article Date: 15 Apr 2008 - 1:00 PDT

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New pivotal trial data from two clinical studies with SEROQUEL XR™ (quetiapine fumarate) once daily Extended Release Tablets were presented today at the Eighth International Review of Bipolar Disorder (IRBD) Conference in Copenhagen, Denmark. The data demonstrated that patients suffering from either bipolar depression1 or bipolar mania2 treated with once-daily quetiapine monotherapy experienced significant symptom reduction as early as the first week of treatment, compared to placebo, and that significant reductions were maintained for the duration of both studies.

Described by experts as one of the most severe forms of mental illness, bipolar disorder is relatively common with a lifetime prevalence of between 3 and 5% worldwide.3 Sufferers experience episodes of mania and depression alongside periods of normal mood, with symptoms ranging from trouble concentrating and sleep disturbance to high-risk behaviour and thoughts of suicide.

Two randomised, double-blind, placebo-controlled studies assessed the efficacy of quetiapine fumarate extended release in patients with bipolar disorder: the first (Study 002) examined acute depressive symptoms in patients with bipolar I or bipolar II disorder1, while the other (Study 004) examined acute manic symptoms in patients with bipolar I disorder2.

Study 002 enrolled 280 acutely depressed adult patients with either bipolar I or II disorder. In patients receiving quetiapine fumarate extended release 300 mg once daily, MADRS (Montgomery-Åsberg Depression Rating Scale) score was significantly reduced from baseline after eight weeks of treatment compared with placebo (-17.4 vs. -11.9, P<0.001). The reduction in MADRS was significant compared to placebo at week 1.

Study 004 enrolled 316 adult bipolar I patients who were currently experiencing a manic or mixed episode. In patients randomised to quetiapine fumarate extended release once daily (300 mg on day 1, followed by 600 mg on day 2 and flexible dosing between 400 and 800 mg for the remainder of the three week study), Young Mania Rating Scale (YMRS) score was significantly reduced from baseline after three weeks of treatment compared with placebo (-14.3 vs. -10.5, P<0.001). The reduction in YMRS was significant compared to placebo at day 4. "In these two studies quetiapine XR provided a reduction in symptoms for patients with bipolar disorder across mixed, manic and depressive episodes," said Professor Patricia Suppes, Southwestern Medical School, Houston, Texas, USA. "That is encouraging for patients and physicians alike as a single medication that if approved can address the spectrum of mood episodes in bipolar disorder as a once-daily monotherapy is an attractive idea."

Treatment with quetiapine fumarate extended release was shown to be generally well tolerated in both acute studies and was consistent with the known safety profile of quetiapine. The most common adverse events in both studies were sedation, dry mouth and somnolence.

SEROQUEL XR™ is approved in the US and 25 further countries for the treatment of schizophrenia in adult patients and for maintenance treatment of schizophrenia in adult patients. It was launched in the US in 2007 and earlier this year AstraZeneca announced the submission of regulatory applications in both the US and European Union for SEROQUEL XR in the treatment of manic episodes associated with bipolar disorder, and the treatment of depressive episodes associated with bipolar disorder. An sNDA for SEROQUEL XR seeking approval for the treatment of Major Depressive Disorder in the US was also announced in February. SEROQUEL XR is not approved for these indications at this time and the applications remain under review by the regulatory authorities.

Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than 22 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 US for the treatment of bipolar depression.

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

*Based on assumptions: (1) estimated number of prescriptions per patient based upon IMS APLD data; and (2) IMS Prescription data for SEROQUEL covering 13 major markets in which this data is available since the time of launch.

SEROQUEL XR is a trademark of the AstraZeneca group of companies.

For more information about AstraZeneca, please visit: http://www.astrazeneca.com

References

1. Suppes T, et al. Effectiveness of the new extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression (trial D144CC00002). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008.

2. Cutler A, et al. Effectiveness of extended release formulation of quetiapine as montherapy for the treatment of acute bipolar mania (trial D144CC00004). Presented at the Eighth International Review of Bipolar Disorder Conference, Copenhagen, Denmark, 14-16 April, 2008.

3. Shastry BS. Bipolar disorder: an update. Neurochem Int 2005;46:273-9.

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