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FDA Approves Paxil CR™ For The Treatment Of Social Anxiety Disorder

In October 2003, the US Food and Drug Administration (FDA) approved Paxil CR (paroxetine HCl) Controlled-Release Tablets for the treatment of social anxiety disorder.  Paxil CR is the first and only controlled-release SSRI (selective serotonin reuptake inhibitor) approved for social anxiety disorder, a potentially debilitating condition that affects more than 10 million Americans.  In clinical trials, Paxil CR was generally well tolerated, with a low patient drop out rate due to adverse events compared to placebo (3% vs. 2% respectively). Paxil CR is also indicated for the treatment of depression, panic disorder and premenstrual dysphoric disorder (PMDD).

"Adverse events and poor compliance are often stumbling blocks in treating disorders like social anxiety disorder.   As a result, many patients continue to suffer the debilitating symptoms of their condition, which often severely limits their social, home and work relationships," said Dr. Murray Stein, Professor of Psychiatry, University of California San Diego.  "The low rate of drop outs due to adverse events seen with the Paxil CR social anxiety disorder study may offer new hope to patients."

The tolerability and efficacy of Paxil CR (paroxetine HCl) Controlled-Release Tablets in the treatment of social anxiety disorder were established in a 12-week, multi-center, placebo-controlled study of 370 patients. Patients were randomized to receive either a flexible dose regimen of Paxil CR (12.5 mg - 37.5 mg per day) or placebo.  Patients given Paxil CR showed statistically significant and clinically meaningful differences versus placebo in the two primary efficacy variables: mean change from baseline in the Liebowitz Social Anxiety Scale (LSAS) and percent of responders defined by a CGI-Global Improvement score of one (very much improved) or two (much improved).

Social anxiety disorder, also known as social phobia, is the most common type of anxiety disorder.  It affects more Americans than general anxiety disorder, which is the second most common type of anxiety disorder.  People with social anxiety disorder have an intense fear of being scrutinized by other people in social or performance situations. When exposed to "everyday" social situations such as meetings, classes, parties, speaking in public and talking to strangers or authority figures, people with social anxiety disorder may literally become "sick with fear" and often develop symptoms including rapid heartbeat, sweating, shaking and upset stomach.  Some people with social anxiety disorder avoid these situations altogether, severely limiting their life, work and social relationships.

Social anxiety disorder is considered one of the most under-diagnosed anxiety disorders with only a small percentage of patients receiving treatment.  Often people recognize that they have a life-impairing condition, but do not realize they suffer from an actual medical disorder that can be treated. Ricky Williams, star running back for the Miami Dolphins, was one of those people.  After being diagnosed with social anxiety disorder and getting treatment and therapy, Williams has now taken his struggle to the public hoping to motivate other sufferers, who may be scared or embarrassed, to seek help.  Too often, sufferers of this condition are not even aware that it is a medical condition or that medical treatment is available to them.

For more information on social anxiety disorder, click here.

Created: 12/5/2003  -  Donnica Moore, M.D.

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