Pharmaprojects R&D Pipeline News Feed
AstraZeneca submits sNDA for Seroquel XR for generalized anxiety disorder
12 May 2008
AstraZeneca's sustained release formulation of quetiapine fumarate (Seroquel XR) is now awaiting approval in the US for the treatment of generalised anxiety disorder (GAD), as well as for maintenance of antianxiety effect. It is the first filing for an atypical antipsychotic medicine in this indication. The submission is based on a data from a Phase III trial involving more than 3,000 patients, which showed significant symptom improvements in patients treated with Seroquel XR compared to placebo.
Seroquel XR was first launched in the US last December for the treatment of schizophrenia, and subsequently approved for the maintenance and prevention of relapse in patients already benefiting from treatment. It is currently approved in 23 countries and awaiting approval in Europe and the US for the treatment of manic and depressive episodes associated with bipolar disorder.
GAD affects around 6.8 million adults in the US and is characterized by chronic anxiety, exaggerated worry and tension. Treatment typically includes serotonin norepinephrine reuptake inhibitors (SNRIs) or selective-serotonin reuptake inhibitors (SSRIs); however, 30% do not achieve an adequate response to short-term treatment. Benzodiazepines, commonly prescribed, are used for the rapid relief of anxiety symptoms, but long-term use is not recommended.
