Paxil CR for fibromyalgia
This article was originally published in Pharmaceutical Approvals Monthly
GlaxoSmithKline's Paxil CR produces a significant reduction in symptoms in patients with fibromyalgia, according to a placebo-controlled study presented May 4 at the American Psychiatric Association annual meeting. In the 12-week Phase III study, 116 patients were randomized to controlled-release paroxetine (mean dose 39.1 mg daily) or placebo; 57% of Paxil CR patients reached the primary efficacy measure of a 25% reduction in the Fibromyalgia Impact Questionnaire compared to 33% of placebo patients. No significant difference was seen on the Visual Analogue Scale for pain. GSK says it currently does not plan to file for the indication...
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