AstraZeneca submits sNDA for Seroquel XR
9 May 2008 00:00 in Pharmaceutical Company Product News
AstraZeneca has submitted a supplemental New Drug Application (sNDA) for the approval of its Seroquel XR treatment for generalised anxiety disorder (GAD).
The company said it is seeking approval for an extended release tablet of the drug based on a "robust clinical development programme" that involved over 3,000 patients in a number of clinical trials.
GAD is characterised by chronic, persistent and often irrational worry, anxiety and stress. It is diagnosed when a person "excessively worries about a number of everyday problems" for a period of at least six months.
According to AstraZeneca, studies showed "significantly greater" improvements in symptoms among GAD patients using Seroquel XR compared to placebo in both short-term and maintenance treatments.
A number of GAD treatments are currently available, although around 30 per cent of GAD patients have an inadequate response to short-term treatments. Other forms of treatment, such as benzodiazepines, are not recommended for long-term use, AztraZeneca said.
The National Mental Health Association says physical symptoms of GAD can include fatigue, headaches, insomnia or muscle tension. The disorder affects more women than men.
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