NEWLY APPROVED TREATMENT TO PROVIDE RELIEF TO CANADIANS SUFFERING FROM GENERALIZED ANXIETY DISORDER

Paxil® is the first and only SSRI approved for highly debilitating condition

Mississauga, Ontario - October 3, 2001 - GlaxoSmithKline today announced that the Therapeutic Products Directorate of Health Canada has approved Paxil® (paroxetine hydrocholoride) for the treatment of Generalized Anxiety Disorder (GAD), making it the first and only selective serotonin reuptake inhibitor (SSRI) approved to treat this condition in Canada.

Generalized Anxiety Disorder (GAD) is a chronic, common and highly disabling psychiatric disorder, characterized by excessive and uncontrollable anxiety and worry about a number of events or activities. It is estimated that five per cent of Canadians suffer from GAD, and twice as many women as men are affected. Despite its prevalence and severity, only one third of sufferers receive treatment.

"The approval of Paxil for the treatment of GAD is very welcome news for the many Canadians suffering from this debilitating disorder," stated 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. "GAD sufferers experience significant disability in their work, family and social lives. Paxil now provides a powerful new alternative to help victims of GAD alleviate their uncontrollable worry and anxiety."

Uncontrollable 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 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. Furthermore, the intensity, duration or frequency of the worry is far out of proportion to the actual likelihood or impact of the feared event.

Everyone can experience periods of anxiety and worry. However, the anxiety and worry associated with GAD is chronic and uncontrollable. It must also be accompanied by at least three of the following symptoms for more than six months: restlessness, fatigue, poor concentration, irritability, muscle tension or sleep disturbance. In addition, 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.

Other Psychiatric Disorders and GAD

In up to 90 per cent of cases, GAD coexists with other psychiatric disorders, most notably Depression, which affects up to 62 per cent of GAD patients. Individuals with GAD also frequently suffer from Generalized Social Anxiety Disorder (SAD) and Panic Disorder.

"The approval of Paxil as the first and only SSRI used to treat GAD will be welcomed by clinicians and patients alike," said Dr. Anne Phillips, Vice President of Research & Development, GlaxoSmithKline. "By treating the broadest range of psychiatric disorders, Paxil has the potential to improve the quality of life of patients who suffer from one or more of these disabling conditions," she added.

Paxil is a broad-spectrum medication that is already approved to treat depression and a variety of anxiety disorders, the symptoms of which show extensive overlap with GAD, such as SAD, Panic Disorder and Obsessive-Compulsive Disorder (OCD). In Canada, Paxil has been on the market since 1993 and has been used to treat more than 70 million patients worldwide.

Paxil is generally well tolerated. As with many medications, there can be side effects. The most common side effects reported in depression, SAD, OCD, Panic Disorder or GAD studies include nausea, somnolence and asthenia. 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. 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.

FOR MORE INFORMATION, PLEASE CONTACT:

Carlo Mastrangelo

GlaxoSmithKline

(905) 819-7129

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