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| |  FDA Approves Paxil (Paroxetine) For Treatment Of Generalized Anxiety Disorder PHILADELPHIA, PA -- April 17, 2001 -- GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) approved Paxil® (paroxetine HCl) for the treatment of generalized anxiety disorder (GAD), making it the first and only selective serotonin reuptake inhibitor (SSRI) approved for this disorder in the U.S. Affecting more than 10 million Americans, 60 percent of whom are women, GAD is a debilitating, chronic condition characterized by excessive anxiety and worry about a number of events or activities. Despite its prevalence and severity, only one third of sufferers receive treatment. Paxil is currently indicated for the treatment of depression, panic disorder, obsessive compulsive disorder and social anxiety disorder and is the number one prescribed SSRI in terms of new prescriptions. "The FDA approval of Paxil for the treatment of GAD is promising news for healthcare professionals and the millions of Americans suffering from this paralyzing mental illness," stated Dr. Jack Gorman, Professor and Vice Chair of Research, Department of Psychiatry, Columbia University. "Paxil provides a new alternative to help GAD sufferers regain control over their lives so often impeded by uncontrollable worry and anxiety." The effectiveness of Paxil for GAD was demonstrated in two double-blind placebo-controlled multicenter studies of 897 patients with GAD, 551 of whom received Paxil at doses of 20 to 50 mg/day. Study results demonstrated that patients taking Paxil experienced a nearly 60 percent reduction in anxiety symptoms as measured by the Hamilton Anxiety Scale (HAM-A), an established standard for evaluating patients' anxiety. Patients in this study were 18 to 80 years old, with the average age being 40. "These new data show that Paxil can help patients significantly reduce their anxiety and worry that would normally interfere with daily living," said Dr. David Sheehan, Professor of Psychiatry and Director of the Office of Research, Department of Psychiatry and Behavioral Medicine at University of South Florida College of Medicine. "Now, with the help of Paxil, patients can focus on regaining control of their personal relationships, careers and overall lifestyle." People with GAD have persistent and exaggerated worry, anxiety and tension over routine and life circumstances, which can severely impact their work, social life and family relationships. They often report feeling anxious their entire lives, worry constantly (without apparent reason) and experience difficulty in controlling the worry. The worry can be about work, health, family, money or even minor matters, such as household chores or being late for appointments. Furthermore, the intensity, duration and frequency of the worry is out of proportion to the actual likelihood or impact of the feared event. "People with GAD are caught in a cycle of worry," stated Dr. Sheehan. "For example, I have seen patients who call their spouse's work and children's school daily to ensure they arrived without incident." Everyone can experience periods of anxiety and worry. However, the anxiety and worry associated with GAD is chronic and uncontrollable. Furthermore, it must be accompanied by at least three of the following symptoms, for more days than not, for at least six months: restlessness, fatigue, difficulty concentrating, irritability, muscle tension or sleep disturbance. GAD sufferers often experience somatic symptoms such as nausea, diarrhea, difficulty swallowing, sweating or dry mouth. Irritable bowel syndrome or headaches, conditions that may be associated with stress, frequently accompany GAD. In up to 90 percent of cases, GAD coexists with other psychiatric disorders, most notably social anxiety disorder, which affects up to 59 percent of GAD patients. Individuals with GAD also frequently suffer from depression and panic disorder. "We are pleased that Paxil is now approved to treat an even broader range of anxiety disorders," said David Stout, President of Pharmaceuticals -- North America, GlaxoSmithKline. "With the most indications in its class, Paxil has the potential to improve the mental health of patients who suffer from mood and anxiety disorders, many of whom experience comorbid psychiatric conditions." Paxil has been on the market for nearly 10 years and has been used to treat depression and a wide range of anxiety disorders, with more than 70 million patient treatments worldwide. In addition to being approved to treat depression, obsessive compulsive disorder, panic disorder, social anxiety disorder and generalized anxiety disorder, Paxil is currently under FDA review for the treatment of posttraumatic stress disorder (PTSD). 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, social anxiety disorder or generalized anxiety disorder studies include asthenia, infection, 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 or thioridazine should not take Paxil. Most people who experience side effects are not bothered enough to stop taking Paxil. SOURCE GlaxoSmithKline
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