Publications - Cara Therapeutics

Until a relevant regulatory agency has approved a Cara Therapeutics product for a specific disease or population, any scientific publication or presentation regarding such disease or population is not to be considered instructions on the use of the Cara Therapeutics product or clinical development candidate.

If you have any questions about our papers, please contact us.

Pruritus in Dialysis Dependent Chronic Kidney Disease

Pharmacokinetics, Metabolism, and Excretion of Intravenous [14C]Difelikefalin in Healthy Subjects and Subjects on Hemodialysis

Stark JG, et al. Clinical Pharmacokinetics. 2023; pre-publication

Assessment of the physical dependence potential of difelikefalin: Randomized placebo-controlled study in patients receiving hemodialysis

Spencer RH, et al. Clinical and Translational Science. 2023; pre-publication

Efficacy of Difelikefalin for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies

Topf J, et al. Kidney Medicine. 2022;4(8): 100512.

Safety and Tolerability of Difelikefalin for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program

Fishbane S, et al. Kidney Medicine. 2022;4(8): 100513.

Reduction of Pruritus by Difelikefalin Correlates with Reductions in Markers for Pruritus and Inflammation in Subjects Undergoing Hemodialysis

Shirazian S, et al. Presented at the National Kidney Foundation Spring Clinical Meetings, 2022.

An Open-label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous Difelikefalin in Patients with Moderate-to-Severe Pruritus Undergoing Hemodialysis

Weiner D, et al. Presented at the European Renal Association – European Dialysis and Transplant Association Congress, 2021.

A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus

Fishbane S, et al. New England Journal of Medicine. 2020;382: 222-232

Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients

Fishbane S, et al. Kidney International Reports. 2020;5: 600-610

Pruritus in Non-Dialysis Dependent Chronic Kidney Disease

A Phase 2 Study of Oral Difelikefalin in Subjects with Chronic Kidney Disease and Moderate-to-Severe Pruritus

Yosipovitch G, et al. Journal of the American Academy of Dermatology. (2023), doi: https://doi.org/10.1016/ j.jaad.2023.03.051

Pruritus in Atopic Dermatitis

Difelikefalin Suppresses Itch and Reduces Scratching Independent of Inflammation in a Murine Model of Atopic Dermatitis

Tamari M, et al. Journal of Allergy and Clinical Immunology. 2023; pre-publication

Oral Difelikefalin Reduces Moderate-to-Severe Pruritus and Expression of Pruritic and Inflammatory Biomarkers in Subjects With Atopic Dermatitis

Guttman-Yassky E, et al. Journal of Allergy and Clinical Immunology. 2023; pre-publication

Oral Difelikefalin Improves Itch and Inflammatory Biomarkers in Atopic Dermatitis Subject With Moderate-to-Severe Pruritus

Guttman-Yassky E, et al. Presented at the American Academy of Dermatology Annual Meeting, 2022

Oral Difelikefalin Reduces Pruritus in Atopic Dermatitis

Kim B, et al. Presented at the European Academy of Dermatology and Venereology Congress, 2021

Pruritus in Notalgia Paresthetica

Rapid Reduction and Free or Almost Free of Itch Response with Oral Difelikefalin in Subjects with Notalgia Paresthetica and Moderate-to-Severe Pruritus

Lebwohl M, et al. Presented at the American Academy of Dermatology Annual Meeting, 2023

Phase 2 Trial of Difelikefalin in Notalgia Paresthetica

Kim B, et al. New England Journal of Medicine. 2023; 388:511-517.

A Phase 2 Study of Oral Difelikefalin for Moderate-to-Severe Pruritus in Subjects with Notalgia Paresthetica (KOMFORT)

Kim B, et al. Presented at the European Academy of Dermatology and Venereology Congress, 2022.

Understanding the patient experience of living with notalgia paresthetica: A qualitative interview study

Bacci E, et al. Journal of the American Academy of Dermatology International. 2022;8: 94-101

Kappa Opioid Receptor Agonism with Difelikefalin

Evaluation of the abuse potential of difelikefalin, a selective kappa-opioid receptor agonist, in recreational polydrug users

Shram M, et al. Clinical and Translational Science. 2022;15: 535-547

Effect of difelikefalin, a selective kappa-opioid receptor agonist, on respiratory depression: A randomized, double-blind, placebo-controlled trial

Viscusi E, et al. Clinical and Translational Science. 2021;14: 1886-1893

Validation of Patient-Reported Outcomes

Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus

Vernon M, et al. Journal of Patient-Reported Outcomes. 2021;5: 1-12

Clinically meaningful change in itch intensity scores: An evaluation in patients with chronic kidney disease-associated pruritus

Vernon M, et al. Journal of the American Academy of Dermatology. 2021;84: 1132-1134