ARTICLE | Clinical News
Jazz planning NDA for narcolepsy therapy JZP-258
April 5, 2019 6:19 PM UTC
Jazz said JZP-258 met the primary endpoint in a Phase III trial to treat cataplexy and excessive daytime sleepiness in adults with narcolepsy. Jazz Pharmaceuticals plc (NASDAQ:JAZZ) will meet with FDA to discuss the data and plans for an NDA submission.
Among 134 evaluable patients in the double-blind, international trial, JZP-258 significantly decreased the weekly number of cataplexy attacks over the 2-week randomized-withdrawal period vs. placebo. JZP-258 also met the secondary endpoint of improving Epworth Sleepiness Scale (ESS) score vs. placebo...
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