APA: Paxil (Paroxetine) Effective in Treating Generalized Anxiety Disorder

CHICAGO, IL -- May 15, 2000 --

Paxil(R) (paroxetine HCl) significantly reduced anxiety in patients with generalized anxiety disorder, as demonstrated by data presented at the American Psychiatric Association annual meeting.

Generalized anxiety disorder (GAD) is a condition characterized by excessive anxiety and worry about a number of events or activities; it is debilitating to those who suffer from it. Paxil, a selective serotonin reuptake inhibitor (SSRI), is currently indicated by the U.S. Food and Drug Administration (FDA) for the treatment of depression, panic disorder, obsessive compulsive disorder and social anxiety disorder.

"The data presented today suggest that Paxil may be a new alternative for patients suffering from generalized anxiety disorder," said Jack Gorman, M.D., Professor and Vice Chair of Research, Department of Psychiatry, Columbia University. "With few treatments currently available to treat generalized anxiety disorder, new treatments will help in the fight against this debilitating disorder."

Results from a double-blind placebo-controlled multi-center study of 566 patients with GAD indicate that patients taking Paxil experienced nearly a 60 percent reduction in anxiety symptoms as measured by the Hamilton Anxiety Scale (HAM-A). HAM-A is regarded as an established standard for evaluating patients' anxiety.

In addition, Paxil was significantly superior to placebo in reducing tension (item two on HAM-A) and severity of illness (global assessment by clinician) and disability (as measured by the Sheehan Disability Scale). Patients in the study were between 18-80 years old, with the average age being 40. Results from this study were included in a supplemental New Drug Application recently submitted to the FDA in April.

GAD affects as many as 14 million Americans and 1.5 million Canadians at some point during their lives. The condition is characterized by chronic, exaggerated tension and worry that interferes with daily functioning for at least six months. Individuals with GAD worry constantly, even when there is no apparent reason for doing so, and experience difficulties controlling the worry. The intensity, duration, or frequency of the worry is far out of proportion to the actual likelihood or impact of the feared event. The focus of their worries can be surrounding work, health, family, money, or even minor matters, such as household chores or being late for appointments.

Those with GAD suffer from at least three of the following symptoms: restlessness, fatigue, difficulty concentrating, irritability, muscle tension or sleep disturbances. Research shows that GAD sufferers frequently suffer from additional mood and anxiety disorders including major depression, panic disorder and social anxiety disorder.

More women than men are diagnosed with the condition, with approximately 60 percent of sufferers being female. Symptoms of GAD can begin at any time in a sufferer's life. People who suffer from GAD often report feeling nervous and anxious throughout their entire lives, which can severely impact one's work, social life and family relationships.

"Generalized anxiety disorder severely impacts sufferers' abilities to maintain personal relationships, careers and living the life they want," said David Sheehan, M.D., Professor of Psychiatry and Director of the Office of Research, Department of Psychiatry and Behavioral Medicine at University of South Florida College of Medicine. "This research shows how an effective treatment may help people overcome the impact of the disorder."

Paxil is not currently approved to treat GAD. Paxil is generally well tolerated. As with many medications, there can be side effects. The most common side effects reported in depression, OCD, panic disorder or social anxiety disorder studies include asthenia, sweating, nausea, dry mouth, constipation, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, yawn and sexual side effects in men and women. People taking MAO inhibitors should not take Paxil. Most people who experience side effects are not bothered enough to stop taking Paxil.

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