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AZ seeks Seroquel anxiety approval in Europe
21 Oct 2008
Regulatory Affairs
AstraZeneca (AZ) has applied for European approval for the use of Seroquel XR (quetiapine) in the treatment of generalised anxiety disorder (GAD).
The application relates to the use of Seroquel XR both for short-term and maintenance treatment of the condition.
According to the company, it is the first time that approval has been sought in Europe for the use of an atypical antipsychotic in the treatment of GAD.
Data from a clinical trial programme which involved more than 3,500 patients form the basis of the submission.
AZ stated "significantly greater symptom improvements were seen in patients treated with quetiapine XR compared to those treated with placebo in short-term treatment".
Furthermore, the firm said that the treatment demonstrated a rapid onset of activity - "with improvement observed as early as day four" - with that level said to have been maintained throughout the maintenance treatment.
AZ recently announced that once-daily Seroquel XR extended-release tablets had received approval in the US for the treatment of symptoms associated with bipolar disorder.
