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