AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of...(nherent in schizophrenia and close super...),Health

The most commonly observed adverse events associated with the use of SEROQUEL XR versus placebo in clinical trials for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% vs 4%), and orthostatic hypotension (7% vs 5%).

In long-term clinical trials of quetiapine, hyperglycemia (fasting glucose greater than or equal to 126 mg/dL) was observed in 10.7% of patients receiving quetiapine (mean exposure 213 days) vs 4.6% in patients receiving placebo (mean exposure 152 days).

Please see Prescribing Information, including Boxed Warnings, for SEROQUEL XR.

About Generalized Anxiety Disorder (GAD)

GAD is characterized by chronic anxiety, exaggerated worry, and tension, even when there is little or nothing to provoke it.(1,2) People with GAD anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work.

People with GAD can't seem to get rid of their concerns, even though they usually realize that their anxiety is more intense than the situation warrants.(1,2) They can't relax, startle easily, and have difficulty concentrating. Often they have trouble falling asleep or staying asleep. Physical symptoms that often accompany the anxiety include fatigue, headaches, muscle tension, muscle aches, difficulty swallowing, trembling, twitching, irritability, sweating, nausea, lightheadedness, having to go to the bathroom frequently, feeling out of breath, and hot flashes. GAD is diagnosed when someone excessively worries about a number of everyday problems for at least 6 months.

In the U.S. GAD affects about 6.8 million adults, with women twice as likely to develop GAD as men.(1,2) The disorder comes on gradually and can begin across the life cycle. GAD rarely occurs alone and is often accompa
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