FOR IMMEDIATE RELEASE

FIRST AND ONLY MEDICATION FOR PATIENTS SUFFERING FROM POSTTRAUMATIC STRESS DISORDER RECEIVES APPROVAL

Paxil® approved in Canada for crippling psychiatric disorder

Mississauga, Ontario - May 15, 2002 - The Therapeutic Products Directorate (TPD) of Health Canada has approved Paxil® (paroxetine hydrochloride) for the treatment of Posttraumatic Stress Disorder (PTSD), making it the first and only medication approved to treat this debilitating condition in Canada.

Posttraumatic Stress Disorder is a chronic, common and highly disabling psychiatric disorder characterized by an impending sense of intense fear or hopelessness. It often results from experiencing or witnessing a traumatic event such as a car accident, natural disaster, physical attack or abuse, robbery, kidnapping, sexual assault or military combat. It is estimated that almost two and a half million Canadians will suffer from PTSD in their lifetime.

"Without effective treatment, PTSD can undermine a person's ability to cope with every day interactions with their family, friends and colleagues," said Dr. Martin Katzman, Assistant Professor in the Department of Psychiatry at the University of Toronto and Staff Psychiatrist in the Anxiety Disorders Clinic at the Centre for Addiction and Mental Health. "It is important for those suffering with PTSD, and those who suspect they may have it to speak to their physicians. PTSD can have devastating consequences for months or even years after experiencing or witnessing a traumatic event. With Paxil's approval, we have a much greater chance of successfully treating PTSD."

A Patient's Perspective

Phillip Nolan experienced two horrendous traumas, the most recent one is a result of the September 11th terrorist attacks. His life changed dramatically after he returned home from New York where he was working as a television cameraman. Mr. Nolan was later diagnosed with PTSD by a psychiatrist in Ottawa. "After my experience at Ground Zero, I was left with an emotional aftermath of numbness and irritability. Every day, I experienced disturbing memories, fear or a sense of terror. I felt relieved to know there was a name for my symptoms and that my doctor could help me out of this horrible state by providing medication and therapy."

The Symptoms of PTSD

People with PTSD experience three "clusters" of symptoms that often last for more than one month.¹

The three clusters are characterized by the following:

• Re-experiencing or flashbacks: Symptoms include flashbacks of the trauma, nightmares or other intrusive thoughts.
• Avoidance: Symptoms include avoidance of activities, places, people or topics associated with the trauma. Loss of interest in and withdrawal from everyday activities is also common.
• Hyperarousal (increased startle response): Symptoms include irritability, jumpiness, outbursts of anger, an extreme sense of being "on guard," problems concentrating and insomnia.

"In my practice, I often combine Paxil with psychotherapy to help relieve the devastation that patients face because of uncontrolled symptoms," said Dr. Katzman. "Paxil clearly shows efficacy in relieving the symptoms of PTSD that my patients find so disabling. If symptoms persist for any longer than a month, professional help should be sought."

Clinical trial data show that patients taking Paxil experienced as much as a 50 per cent reduction in PTSD symptom severity when they were treated with Paxil versus placebo over a twelve-week period.² They reported a significant improvement in the their ability to function in everyday work, social and family life. In the same study, 22 per cent of patients taking Paxil reported feeling very much or much improved after only two weeks of treatment.

PTSD symptoms usually develop within the first three months after the trauma but may not appear until months or years have passed. Currently, the vast majority of PTSD sufferers do not receive treatment because they do not associate their symptoms with a past traumatic experience. If PTSD sufferers are not treated, the disease can have a major impact on an individual's life and the symptoms can last for more than 20 years.

Research shows that if PTSD is left untreated, sufferers are six times more likely to attempt suicide³ and two to three times more likely to have drug or alcohol abuse problems than people without PTSD.⁴

PTSD and Other Related Anxiety Disorders

PTSD often occurs with other serious psychiatric disorders including depression, Panic Disorder and Obsessive-Compulsive Disorder. Up to 80 per cent of people with PTSD also simultaneously experience one or more of these disorders.⁴ Paxil has been indicated to treat more conditions across the range of depression and anxiety disorders than any other antidepressant.

In Canada, Paxil has been on the market since 1993 and has been used to treat more than 100 million patients worldwide. Paxil is generally well-tolerated. The most common side effects reported in clinical studies include headache, nausea and, somnolence (sleepiness). These effects are generally mild, self-limiting and go away on their own. People taking monoamine oxidase inhibitors or thioridazine should not take 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. In Canada, GlaxoSmithKline employs more than 1,800 people and is a top 20 investor in Canadian research and development, contributing more than $100 million annually. The company is also one of the top 10 corporate charitable donors, investing more than $6.5 million annually and is recognized as one of the 50 best companies to work for in Canada.

FOR MORE INFORMATION, PLEASE CONTACT:

Carlo Mastrangelo / Jill McKinlay

GlaxoSmithKline

(905) 819-3000

Cindy Woodcock / Alison Pozzobon

NATIONAL PharmaCom

(416) 586-0180

Paxil ® is a registered trademark, used under license by GlaxoSmithKline Inc.

Reference

1. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 4th ed. (DSM-IV), Am Psych Assoc, Washington DC, American Psychiatric Association, 2000
2. Tucker P et al. Paroxetine in the treatment of chronic PTSD: Results of a placebo-controlled flexible dosage trial. J Clin Psych 2001; 62:860-868
3. Kessler RC, Borges G, Walters EE. Prevalence of and risk factors for lifetime suicide attempts in the National Comorbidity Survey. Arch Gen Psychiatry. 1999; 56:617-626
4. Kessler RC, Sonnega A, Bromet E, et al. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry 1995; 52:1048-1060