Study Shows Paxil CR(TM) Is Effective and Generally Well-Tolerated For Patients With Social Anxiety Disorder Paxil CR, the First and Only Controlled-Release SSRI Approved for Social Anxiety Disorder, Demonstrated a Low Rate of Patient Dropouts in the Study PHILADELPHIA, Feb. 17 /PRNewswire-FirstCall/ -- GlaxoSmithKline's Paxil CR(TM) (paroxetine HCl) Controlled-Release Tablets is a generally well-tolerated treatment for social anxiety disorder, according to a study published in the February issue of the Journal of Clinical Psychiatry. In the study, approximately three times as many patients taking Paxil CR achieved remission compared to placebo. In addition, dropout rates due to adverse events such as sexual dysfunction were low and comparablefor both treatment groups. These findings are important since discontinuation of treatment is a well-recognized issue in managing social anxiety disorder. Recently approved for the treatment of social anxiety disorder, Paxil CR is the first and only controlled-release SSRI (selective serotonin reuptake inhibitor) indicated for this condition. Paxil CR is also indicated for the treatment of depression, panic disorder and premenstrual dysphoric disorder (PMDD). "This data are significant because itshows that patients with social anxiety disorder, which is the most common anxiety disorder, who take Paxil CR can effectively manage their symptoms with a low rate of patient dropouts due to adverse events that are commonly associated with SSRIs," said Dr. Murray Stein, Professor of Psychiatry, University of California San Diego. "Our hope is that patients will be better able to maintain a drug treatment regimen, thus increasing the likelihood of remission and improved outcomes." Social anxiety disorder, also known as social phobia, is the most common type of anxiety disorder, affecting millions of Americans. People with social anxiety disorder have an intense fear of being scrutinized by other people in social or performance situations. When exposed to "common" social situations such as meetings, classes, parties, speaking in public and talking to strangers or authority figures, people with social anxiety disorder have literally become marked, "sick with fear," and often develop symptoms including rapid heartbeat, sweating, shaking and upset stomach. Some people with social anxiety disorder avoid these situations all together, severely limiting their life, work and social relationships. Additionally, in 70 to 80 percent of cases, social anxiety disorder is complicated by the presence of additional psychiatric conditions such as depression or panic disorder, which add to the burden of the condition. Paxil CR Significantly Improved Symptoms of Social Anxiety Disorder In this multi-center, randomized, double-blind, placebo-controlled, flexible-dose study, patients with social anxiety disorder were randomly assigned to receive Paxil CR(TM) (paroxetine HCl) Controlled-Release Tablets (flexible dose: 12.5 mg to 37.5 mg/day) (n=186) or placebo (n=184) for 12 weeks of treatment following a one-week, single-blind, placebo run-in period. The primary efficacy measures were the change from baseline in the Liebowitz Social Anxiety Scale (LSAS) and proportion of responders based on the Clinical Global Impression (CGI), Global Improvement score. Patients who received Paxil CR experienced a statistically significant reduction in the LSAS total score and in both the Fear or Anxiety and Avoidance subscales compared to those patients randomizedto placebo. In the CGI Global Improvement responder analysis, nearly twice as many patients treated with Paxil CR achieved a score of "very much improved" or "much improved," compared to patients treated with placebo. Furthermore, approximately threetimes as many patients treated with Paxil CR achieved clinical remission, compared to patients treated with placebo. The American Psychiatric Association (APA) recognizes discontinuation of treatment as an issue to managing anxiety and depression. Studies show that more than 40 percent of patients drop out of treatment within the first 90 days. To achieve full remission, the APA recommends continued treatment for four to five months. Controlled-Release Paxil CR Tablets Paxil CR(TM) (paroxetine HCl) Controlled-Release Tablets offers the proven efficacy of paroxetine in a Geomatrix oral drug delivery system. The tablet is a multi-layered formulation that controls dissolution and allows absorption of the drug further down in the small intestine.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 (NASDAQ:SKYE/LSE:SKP). Most common adverse events (incidence of 5 percent or greater 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, yawning, sweating, abnormal vision, asthenia, insomnia, abnormal ejaculation, female genital disorders and impotence. Patients should not be abruptly discontinued from antidepressant medication, including Paxil CR. Concommitant use of Paxil CR in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated. For more information on Paxil CR log on to http://www.paxilcr.com/, or for patients who are being treated with Paxil CR, visit CRBalance.com. 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. Company information line: 1-888-825-5249. Web site address: http://www.gsk.com/. DATASOURCE: GlaxoSmithKline CONTACT: Nancy Leone of GlaxoSmithKline, +1-919-483-2839; or Amy Takis of Cohn & Wolfe, +1-212-798-9521, for GlaxoSmithKline Web site: http://www.paxilcr.com/ http://www.gsk.com/

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