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Daiichi Sankyo Pain Drug Meets Endpoint in One Phase III Trial, and Fails Another

06:13 EDT 30 Jun 2017 | Genetic Engineering News

Daiichi Sankyo reported mixed results from the Phase III NEUCOURSE and ALDAY clinical trials with its oral pain management candidate, mirogabalin. The 14-week placebo-controlled NEUCOURSE study in Asian patients with post-herpetic neuralgia met its primary endpoint, and demonstrated that treatment using one of two doses of mirogabalin twice daily resulted in statistically  significant reductions in the weekly average daily pain score (ADPS). The NEUCOURSE study involved 765 patients aged 20 years and older in Japan, Taiwan, Korea, Singapore, Malaysia and Thailand. The double-blind phase of the study was followed by a one-year, open-label extension. In contrast, three 13-week ALDAY trials assessing mirogabalin in the treatment of pain associated with fibromyalgia failed to meet their primary efficacy endpoint of statistically significant reductions from baseline in the weekly average of worst daily pain score. The three identical global ALDAY studies evaluated mirogabalin in over 3,600 patients aged 18 years and ...

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