AstraZeneca's Seroquel XR receives complete response letter for GAD
This article was originally published in Scrip
The US FDA has issued AstraZeneca with a complete response letter for its antipsychotic Seroquel XR (quetiapine fumarate) extended-release tablets for the treatment of generalised anxiety disorder (GAD) in adults.
The company would not disclose the nature of the letter, but said that it is evaluating its contents and some proposed labelling revisions.
It follows an FDA complete response letter for Seroquel XR in major depressive disorder issued in December (www.scripnews.com, December 30th, 2008).
The FDA's psychopharmacologic drugs committee has tentatively scheduled to meet on April 8th to discuss the safety and efficacy for Seroquel XR for the treatment of major depressive disorder and generalised anxiety disorder.
Seroquel XR, the extended-release formulation of Seroquel, is approved in the US for the treatment of schizophrenia in adults, and for the acute treatment of both depressive and manic episodes associated with bipolar disorder.
The filing for GAD is based on data from two Phase III studies. In the first study, Seroquel XR demonstrated a significant reduction in anxiety symptoms over eight weeks, as assessed by the Hamilton rating scale for anxiety. The second trial showed that Seroquel XR significantly reduced the frequency of anxiety events (www.scripnews.com, May 16th, 2008).