FDA Approves Paxil(R) for the Treatment of Generalized Anxiety Disorder

Paxil(R) Now the First and Only SSRI Approved

For Highly Debilitating Condition



Apr 16, 2001, 01:00 ET from GlaxoSmithKline

    PHILADELPHIA, April 16 /PRNewswire/ -- GlaxoSmithKline today announced
 that the U.S. Food and Drug Administration (FDA) approved Paxil(R) (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% 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."
 
     Paxil Effective for the Treatment of Generalized Anxiety Disorder
     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% 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."
 
     Worry, Anxiety and Tension: Living with GAD
     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.
 
     Cormorbidity and GAD
     In up to 90% of cases, GAD coexists with other psychiatric disorders, most
 notably social anxiety disorder, which affects up to 59% 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.
 
     About GlaxoSmithKline
     GlaxoSmithKline -- one of the world's leading research-based
 pharmaceutical and healthcare companies -- is committed to improving the
 quality of human life by enabling people to do more, feel better and live
 longer.
 
     Customer information line: 1-888-825-5249
     Web site address: http://www.gsk.com
 
 

SOURCE GlaxoSmithKline
    PHILADELPHIA, April 16 /PRNewswire/ -- GlaxoSmithKline today announced
 that the U.S. Food and Drug Administration (FDA) approved Paxil(R) (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% 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."
 
     Paxil Effective for the Treatment of Generalized Anxiety Disorder
     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% 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."
 
     Worry, Anxiety and Tension: Living with GAD
     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.
 
     Cormorbidity and GAD
     In up to 90% of cases, GAD coexists with other psychiatric disorders, most
 notably social anxiety disorder, which affects up to 59% 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.
 
     About GlaxoSmithKline
     GlaxoSmithKline -- one of the world's leading research-based
 pharmaceutical and healthcare companies -- is committed to improving the
 quality of human life by enabling people to do more, feel better and live
 longer.
 
     Customer information line: 1-888-825-5249
     Web site address: http://www.gsk.com
 
 SOURCE  GlaxoSmithKline