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FDA Approves Paxil CR (Paroxetine HCl) for Treatment of Social Anxiety Disorder

PHILADELPHIA, PA -- October 17, 2003 -- GlaxoSmithKline today announced the U.S. 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 highly debilitating condition that affects more than 10 million Americans.

Furthermore, Paxil CR was generally well tolerated, with a low patient drop out rate due to adverse events that was comparable 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."

Treatment with Paxil CR
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 with social anxiety disorder. 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).

"We are pleased to offer physicians and patients a new option in the treatment of social anxiety disorder," said Bonnie Rossello, Vice President, Cardiovascular/Neuroscience, GlaxoSmithKline. "As one of the most popular treatments for depression and anxiety disorders, Paxil has been successful in helping people treat their condition, and now, as the first controlled-release SSRI approved to treat social anxiety disorder, Paxil CR builds on the heritage of Paxil and has a favorable tolerability profile."

Social Anxiety Disorder
Social anxiety disorder, also known as social phobia, is the most common type of anxiety disorder, with more sufferers than general anxiety disorder, which currently ranks second. 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 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.

NFL Star Ricky Williams Urges Others to Seek Help
Social anxiety disorder is considered one of the most underdiagnosed 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 is now public with his battle in hopes of motivating other sufferers, who may be scared or embarrassed, to seek help.

"I didn't know what was wrong with me, but I got to the point where I didn't want to leave my house, not even to get the mail," said Williams. "But once I learned that I had a real medical condition that could be treated, everything began to change. As someone who has suffered from social anxiety disorder, I am so happy that new treatment options, like Paxil CR, are available today to help people with the condition."

Controlled-Release Paxil Tablets
Paxil CR offers the proven efficacy of paroxetine in a Geomatrix oral drug delivery system. The tablet is a multi-layered formulation that controls dissolution and absorption of the drug in the body. Paxil CR offers flexible dosing with three dosing strengths: 12.5 mg, 25 mg, and 37.5 mg. Geomatrix technology is licensed from SkyePharma PLC. Most common adverse events (incidence of 5% or greater and incidence for Paxil CR and at least twice that for placebo) in studies for major depressive disorder, panic disorder, PMDD and social anxiety disorder include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawn, sweating, abnormal vision, asthenia, insomnia, abnormal ejaculation, female genital disorders and impotence. Patients should not be abruptly discontinued from antidepressant medication, including Paxil CR. Concomitant use of Paxil CR in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated.


SOURCE: GlaxoSmithKline

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