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Cara Therapeutics Announces Results from the KOMFORT Phase 2 Trial of Oral Difelikefalin for the Treatment of Pruritus in Notalgia Paresthetica Published in the New England Journal of Medicine
Publication underscores the importance of data in underrecognized neuropathic itch disorder which lacks an approved treatment STAMFORD, Conn., Feb. 08, 2023
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[{"type":"text","content":"Publication underscores the importance of data in underrecognized neuropathic itch disorder which lacks an approved treatment\nSTAMFORD, Conn., Feb. 08, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the New England Journal of Medicine (NEJM) has published results from the KOMFORT Phase 2 clinical trial of oral difelikefalin in patients with moderate-to-severe pruritus from notalgia paresthetica. The manuscript, titled “Phase 2 Trial of Difelikefalin in Notalgia Paresthetica,” includes data from 126 patients randomized to receive oral difelikefalin 2 mg or placebo twice daily for 8 weeks. “Notalgia paresthetica is an underrecognized neuropathic itch disorder characterized by pruritus of the upper back for which there is no approved treatment,” said Brian Kim, M.D., MTR, lead author of the paper and Vice Chair of Research for the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, NY. “In the KOMFORT Phase 2 trial, oral difelikefalin demonstrated encouraging potential to address the significant unmet need for an effective treatment option for this burdensome condition. I look forward to the continued evaluation of oral difelikefalin in a clinical trial program for the treatment of pruritus in patients with notalgia paresthetica.” The registrational Phase 2/3 program of oral difelikefalin will be enrolling notalgia paresthetica (NP) patients with moderate-to-severe pruritus. The program will be comprised of an 8-week Phase 2 dose-finding portion followed by two identical Phase 3 studies. Following selection of the optimal dose based on the Phase 2 portion of the study, that dose will be evaluated for safety and efficacy in the Phase 3 portion. Further details about the program will be released during a Capital Markets Day on February 16, 2023. KOMFORT Phase 2 Trial Results As previously announced and presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress, the KOMFORT Phase 2 trial evaluating oral difelikefalin in patients with moderate-to-severe pruritus from notalgia paresthetica achieved the primary efficacy endpoint of change from baseline in the weekly mean of the daily 24-hour Worst I...