Cara Therapeutics Announces Outcome of Part A of KOURAGE-1 Study Evaluating Oral Difelikefalin in Notalgia Paresthetica

KOURAGE-1 Part A was a multicenter, randomized, double-blind, placebo-controlled study designed to inform the dose and sample size for the pivotal portions of the Phase 2/3 clinical program. In Part A, 214 patients were randomized to one of four arms: oral difelikefalin 2 mg twice a day (BID), 1 mg BID, 0.25 mg BID or placebo BID for 8 weeks. The primary endpoint was the proportion of patients achieving a ≥4-point improvement from baseline in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I ...