Zoloft social anxiety indication
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA approves Pfizer's Zoloft (sertraline) for acute and long-term treatment of social anxiety disorder Feb. 7. Zoloft is the first selective serotonin reuptake inhibitor to gain a long-term social anxiety indication. Efficacy was shown in two double-blind, placebo-controlled trials in approximately 600 patients. In one study 53% of Zoloft patients had a response compared to 29% of placebo patients. In a continuation of another 20-week study, Zoloft responders were re-randomized for 24 more weeks: 96% of these responders maintained an effective treatment response for 24 weeks vs. 64% with placebo. GlaxoSmithKline's Paxil (paroxetine), which carried the broadest label of the SSRIs, has been approved for acute social anxiety for over three years. Labeling states that efficacy past 12 weeks "has not been systematically evaluated in adequate and well-controlled clinical trials