Cara Therapeutics Reports P-II Trial (KOMFORT) of Difelikefalin for Pruritus in Notalgia Paresthetica Published in the NEJM
Shots:
- The P-II trial (KOMFORT) evaluating difelikefalin (2mg, BID) vs PBO in 126 patients with mod. to sev. pruritus from notalgia paresthetica for 8wks.
- The trial achieved the primary efficacy EPs of change from baseline in the weekly mean of the daily 24hr. WI-NRS score @8wk., the proportion of patients achieved a ≥4-point improvement in WI-NRS score @8wk. (41% vs 18%), CR (22% vs 5%). The secondary outcomes incl. itch-related QoL and itch-related sleep measures, was generally well tolerated
- The company has completed a P-II PoC trial of difelikefalin for mod. to sev. pruritus in patients with notalgia paresthetica and plans to initiate a P-II/III clinical trial program in Q1’23
Ref: Globenewswire | Image: Cara Therapeutics
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