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news.Pipex Pharmaceuticals, a specialty pharmaceutical company, has received ethics committee approval to initiate its double-blind, randomized, placebo-controlled Phase II clinical trial of oral flupirtine for the treatment of fibromyalgia.
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This Phase II clinical trial is designed as a double-blind, placebo-controlled Phase II trial which would evaluate safety and efficacy of oral flupirtine versus placebo in fibromyalgia patients. This Phase II clinical trial is intended to enroll up to 90 subjects and treat subjects for up to 90 days.
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 improvement in overall level of functioning.
Pipex has an exclusive worldwide license to the issued US patent and pending international patents from McLean Hospital, a Harvard University-affiliated teaching hospital, relating to flupirtine’s use to treat fibromyalgia syndrome.