AstraZeneca Announces European Seroquel XR Submission for the Treatment of Generalised Anxiety Disorder
LONDON Oct. 21, 2008- AstraZeneca today announced its submission of SEROQUEL XR (quetiapine fumarate extended release tablets) to European regulatory authorities seeking approval for both short-term and maintenance treatment of Generalised Anxiety Disorder (GAD). This is the first time approval has been sought in Europe for an atypical antipsychotic medicine for the treatment of GAD.
The submission is based on a robust clinical development programme involving more than 3,500 patients in five Phase III efficacy and safety studies. Data from the programme were presented earlier this year at the 21st ECNP Congress in Barcelona in September and at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C. in May. In the data presented, significantly greater symptom improvements were seen in patients treated with quetiapine XR compared to those treated with placebo in short-term treatment, and quetiapine XR demonstrated a fast onset of action with improvement observed as early as day 4. 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.
During their lifetimes, it is estimated between 2.7% and 5.4% of people in Europe will suffer from GAD. Characteristic symptoms include persistent anxiety, exaggerated worry and tension, and GAD is often accompanied by depression or other anxiety disorders. It also has a substantial negative impact on Health-Related Quality of Life (HRQoL), productivity at work (including absenteeism) and healthcare costs.
Antidepressants (SSRIs - selective-serotonin reuptake inhibitors and SNRIs - serotonin and norepinephrine reuptake inhibitors) are standard treatments for GAD that are generally effective, but approximately 30 percent of patients treated with SSRIs or SNRIs will have an inadequate response to short term treatment. Additionally, antidepressants may have a relatively slow onset of action (2-4 weeks), sometimes requiring combination with a short course of benzodiazepines (BZDs) to achieve initial symptom control; however, long term treatment with these agents is generally not recommended.