GlaxoSmithKline 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."

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).