AstraZeneca announces European Seroquel XR submission

AstraZeneca has announced its submission of Seroquel XR (fumarate extended release tablets) to regulatory authorities in Europe as it seeks approval for short-term and maintenance treatment of generalised anxiety disorder (GAD).

The company states this represents the first time European approval has been sought for an atypical antipsychotic medicine for GAD treatment.

AstraZeneca continues to note the submission is based on a clinical development programme which involved more than 3,500 patients in five phase III safety and efficacy studies.

The findings of the trials, presented earlier this year in Washington DC, showed “significantly” greater symptom improvements in patients treated with quetiapine XR in comparison to those given a placebo in short-term treatment.

AstraZeneca continues: “This improvement was shown to be upheld during maintenance therapy. Quetiapine XR was generally well tolerated and the safety and tolerability were consistent with the known safety profile of quetiapine.”

The company notes it is estimated between 2.7 per cent and 5.4 per cent of people in Europe will suffer from GAD over the course of their lifetime, with symptoms including exaggerated worry, tension and persistent anxiety.

Seroquel XR extended release tablets were recently approved by the US Food and Drug Administration for acute treatment of bipolar depression and mania in the USA.