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NPS isovaleramide migraine study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

NPS' alifatic amide neuromodulator isovaleramide (NPS 1776) fails to show significance in a proof-of-concept study in moderate to severe migraine "due to a higher than expected placebo response," NPS says Oct. 11. A positive response was seen in 60% of patients receiving a high dose (800 mg), 64% receiving a low dose (400 mg), and 56% of placebo patients in the 189-patient Phase IIa trial. NPS "will complete its evaluation of data from this study, and plans to continue to explore the development of NPS 1776 in other indications." Other potential indications for isovaleramide include bipolar disorder and epilepsy...

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