Zevra announces data from the Phase 2 clinical trial of KP1077or SDX for IH

Hypersomnia Zevra Therapeutics announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial evaluating the safety and tolerability of KP1077, serdexmethylphenidate, or SDX , in patients with idiopathic hypersomnia IH . This proof-of-concept study was not powered to demonstrate statistical significance. The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale ESS, Idiopathic Hypersomnia Severity Scale IHSS and Sleep Inertia Visual Analog Scale SIVAS will inform the Phase 3 study design….The results from the completed Phase 2 trial provide key information for the design of a potentially pivotal Phase 3 trial of KP1077 in patients with IH….The Company plans to request an end-of-Phase 2 meeting with the U.S. Food and Drug Administration to seek guidance on the Phase 3 clinical trial design.