Paxil Approved In Canada For Social Anxiety Disorder

OAKVILLE, ON -- May 6, 1999 --

Health Canada has approved SmithKline Beecham Pharma’s Paxil(R) (paroxetine hydrochloride) for the treatment of generalised social anxiety disorder (social phobia), making it the first and only medication approved for this indication in Canada.

Social anxiety disorder affects approximately 10 per cent of all Canadians during their lifetime.

In recent years, numerous large-scale, multi-centre clinical trials have demonstrated the ability of Paxil to significantly alleviate the symptoms of social anxiety disorder. The majority of patients treated with Paxil were rated as very much improved or much improved throughout the trials. In addition, treatment was well-tolerated.

"Social anxiety disorder is the third most common psychiatric disorder after depression and alcohol dependence and is also the most common of the anxiety disorders," said Dr. Stanley Kutcher, professor and head, department of psychiatry, Dalhousie University and trial investigator. "News of an effective, safe and well-tolerated treatment for this disabling condition is very welcome indeed. It is my hope that we will now be able to reach out to help a greater number of patients who, all-too-frequently, suffer in silence."

Social anxiety disorder is characterised by an excessive and unrealistic fear of being observed or evaluated by others. People with social anxiety disorder report an overwhelming fear of embarrassment in social or performance situations such as being introduced to people, public speaking or being watched while eating. Those with the disorder will frequently seek to avoid everyday, commonplace situations. Exposure to the situation can cause intense emotional distress. Most people with social anxiety disorder are afraid that others will judge them to be anxious, weak or unintelligent.

The onset of social anxiety disorder often occurs in adolescence, with 90 per cent of people affected by the disorder presenting before the age of 25. The earlier the onset, the more severe and disabling the disorder can become to personal development, educational achievement, career progression and ultimately, long-term well being. In up to 80 per cent of cases, social anxiety disorder is accompanied by other psychiatric disorders such as depression (50 per cent of cases), agoraphobia, panic disorder or alcohol/substance abuse. More than one-third of people will become depressed during their lifetime and one-fifth will develop dependency on alcohol and/or experience panic attacks.

Generally, people with social anxiety disorder experience difficulty in forming long-standing relationships -- 40 per cent never marry -- while a significant number are more likely to drop out of school, experience reduced work performance and may also be substance abusers, particularly alcohol.

In addition, people with social anxiety disorder often experience physical symptoms that they associate with a feared situation. Increased heart rate, sweating, trembling, panicky feelings and blocked speech are the most common physical symptoms. Others include muscle tension, blushing, nausea and diarrhea.

"Until now the treatments for social anxiety disorder have been less than adequate. Psychotherapy including cognitive behavioural therapy, while effective, has not been shown to be suitable for everyone," said Dr. Martin Katzman, staff psychiatrist at the Anxiety Disorders Clinic, Centre for Addiction and Mental Health, Clarke Division and a Lecturer for University of Toronto. "Benzodiazepines have been shown to have a potential for abuse and the development of dependence and earlier antidepressants have been shown to have a multitude of adverse effects.

"With the approval of Paxil, we can now safely prescribe treatments for social anxiety disorder for longer periods of time that are safe, tolerable and effective."

In one of the largest studies on social anxiety disorder published in the Journal of the American Medical Association, 55 per cent of patients treated with Paxil were rated as very much improved or much improved compared with 24 per cent of those receiving placebo.

The efficacy of PAXIL in the treatment of social anxiety disorder has been established in three placebo-controlled studies of 12-weeks in duration with a total of 861 patients. Paxil has been shown to be twice as effective as placebo at reducing anxiety symptoms in treating Social Anxiety Disorder. The trials have shown that treatment with Paxil is well-tolerated.

Paxil has been available in Canada since 1993 and has already successfully treated millions of patients world-wide with depression, panic disorder and obsessive-compulsive disorder. It is currently the most prescribed selective serotonin reuptake inhibitor (SSRI) in Canada. Paxil has been used in more than 37 million patients world-wide.