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Home Industry News AstraZeneca submits Seroquel XR in Europe for MDD

AstraZeneca submits Seroquel XR in Europe for MDD

11th June 2008

AstraZeneca has announced the submission in Europe of Seroquel XR (quetiapine fumarate) extended-release tablets as a treatment for major depressive disorder (MDD) including maintenance therapy,.

The compound has been submitted using the mutual recognition procedure and follows a a supplementary new drug application for the drug in this indication in the US in February.

Seroquel XR is the first atypical antipsychotic to be submitted in the EU for this indication and has been investigated as a potentially new therapy option for patients who are not responding sufficiently to existing medication.

The submission of the drug to the regulatory authorities is supported by the results of a number of short and long-term clinical studies.

“The short-term studies demonstrated that quetiapine XR reduced depressive symptoms by week one whilst the long-term study demonstrated that efficacy was maintained,” the company said.

“The safety and tolerability of quetiapine XR was consistent with the known safety profile of quetiapine.”

AstraZeneca added that it also plans a submission for the drug in Europe for generalised anxiety disorder (GAD) during the second half of the year.

Last month, the company noted that around 30 per cent of GAD patients have an inadequate response to current short-term treatments.

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