Cara Therapeutics Presents Results of Oral Difelikefalin In Painful Itching Disorder

Cara Therapeutics Inc CARA announced results from the KOMFORT Phase 2 clinical trial of oral difelikefalin for moderate-to-severe pruritus in notalgia paresthetica (NP).
Notalgia paresthetica (NP) is a nerve disorder that causes intense and sometimes painful itching in the back impacting quality of life.
The data will be presented at the European Academy of Dermatology and Venereology (EADV) Congress.
The presentation includes data from 125 patients with NP and moderate-to-severe pruritus who were randomized to receive oral difelikefalin 2 mg twice daily or a placebo over an 8-week treatment period.
The primary efficacy endpoint of change from baseline in the weekly mean of the itch score was achieved (-4.0 difelikefalin vs. -2.4 placebo). A statistically significant reduction in itch intensity was observed with oral difelikefalin at Day 1 compared to placebo, and the effect was maintained through Week 8.
A significantly greater proportion of patients achieved a ≥4-point improvement in the itch score at Week 8 with oral difelikefalin vs. placebo (41% difelikefalin vs. 18% placebo, p=0.007).
A higher proportion of patients receiving oral difelikefalin vs. placebo achieved a complete response (22% difelikefalin vs. 5% placebo)
Oral difelikefalin was generally well tolerated, with all adverse events in difelikefalin-treated patients reported as mild or moderate in severity.
Price Action: CARA shares are down 0.27% at $10.93 on the last check Thursday.