Pfizer’s Lyrica Not Effective to Treat Juvenile Fibromyalgia

Pfizer’s Lyrica Not Effective to Treat Juvenile Fibromyalgia
pfizerPfizer recently failed to meet the primary endpoint of its phase 4 study to evaluate a treatment for fibromyalgia in adolescents, called Lyrica (pregabalin) Capsules CV. The company announced in a press release the top-line findings from the clinical trial, revealing that the goal was not achieved, since there was no observable superiority of pregabalin compared to placebo. The double-blind, randomized, placebo-controlled study was designed to assess the safety and efficacy of Lyrica and included 107 adolescent patients between the ages of 12 and 17 years old, which were examined for 15 weeks. However, the investigators concluded that there was no statistically revelant difference regarding the impacts of Lyrica on the mean pain score in comparison with placebo. The difference reported between patients treated with Lyrica and with placebo was only 0.66 points, equivalent to 1.60 points improvement of the baseline for pregabalin-treated patients and 0.94 points for placebo. Therefore, Pfizer was unable to establish the safety and efficacy of Lyrica as a treatment for pediatric fibromyalgia patients. "Pfizer is committed to better unders
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