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news.Pipex Pharmaceuticals has announced that the FDA has opened an investigational new drug application to conduct a double-blind, randomized, placebo-controlled Phase II clinical trial of oral flupirtine for the treatment of fibromyalgia, a rheumatic pain disease.
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This Phase II clinical trial is designed as a double-blind, placebo controlled trial that would evaluate safety and efficacy of oral flupirtine versus placebo in fibromyalgia patients. The trial is intended to enroll up to 90 subjects and treat subjects for up to 90 days and the primary endpoint will be a reduction in musculoskeletal pain and the overall symptoms of fibromyalgia.
Secondary outcomes of the study will be a reduction in the severity of mood, fatigue, cognitive symptoms, and sleep disturbance, as well as improve the overall level of functioning.
Steve Kanzer, Pipex’s chairman and CEO, said: “As we enter this Phase II clinical trial of oral flupirtine for treatment of fibromyalgia, the product’s substantial human experience coupled with the promising human data already generated in refractory fibromyalgia patients, represents an exciting new approach to treating this widespread often debilitating disease.”