22 Jun Study Finds Novel Difelikefalin (Korsuva) Stops the Itch of Chronic Kidney Disease

MedicalResearch.com Interview with:

Dr. Yosipovitch

Gil Yosipovitch, MD, Professor
Miami Itch Center
Lennar Medical Foundation
South Miami Clinic in Coral Gables
University of Miami Health System

MedicalResearch.com: What is the background for this study?

Response: Chronic Pruritus is a common and burdensome condition in patients with end stage chronic kidney disease (CKD). It is Present at all stages of CKD, not only in patients undergoing hemodialysis (including stage 3-5 CKD). There are no approved treatments for this condition in US and Europe. CKD pruritus   has significant impact on quality of life of patients with higher mortality rates due to its effect on sleep.

Studies in the last 2 decades have shown that in patients with CKD pruritus there is an imbalance between endogenous mu opioids that are over expressed to Kappa Opioids that are down regulated.  

Difelikefalin (DFK) is a novel peripherally selective kappa opioid receptor (KOR) agonist.   Study of IV DFK administration  in hemodialysis patients has  recently  been published and showed significant anti Pruritic effect ( NEJM Fishbane et al. 382: 289-290, 2020).

MedicalResearch.com: What are the main findings?

Response: In the current study oral formulations were  tested  in a randomized phase 2 study in  pruritic patients with CKD ( 3-5)  the majority were not on hemodialysis.

DFK 1.0 mg met the primary endpoint, demonstrating significantly greater improvement in Worst Itch (WI)-NRS vs placebo in patients with CKD Treatment effect emerged at week 2 and persisted through 12 weeks the end of the study.

A significantly greater proportion of patients achieved complete response with DFK vs placebo the drug was well tolerated with an excellent safety profile.

MedicalResearch.com: What should readers take away from your report?

Response: That there is hope for our CKD patients who suffer from chronic pruritus.  Kappa Opioid such as DFK seems very promising due to its high efficacy and safety profile.

This treatment would not just be exclusively for HD patients but for other  CKD patients who have moderate to severe itch ( this  unmet population of CKD patients has never been = be treated in clinical trials )  

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: To conduct trials with this drug for other chronic itch conditions with severe itch as the imbalance of mu and kappa opioids is known to occur in chronic itch in multiple diseases. For example in chronic liver disease itch. There is also a possibility that it could be helpful for patients with skin diseases with chronic itch and in itchy conditions like Chronic itch of unknown origin.

 Disclosures: I  received consulting fees and  served as an investigator for Trevi Therapeutics and CARA  both  develop Kappa Opioids.

Citation:

AAD Virtual Meeting 2020

• Efficacy and Safety of Oral Difelikefalin in Chronic Kidney Disease Patients with Moderate-to-Severe Pruritus: A Randomised, Placebo-Controlled, Phase 2 Trial: Gil Yosipovitch, MD

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Last Updated on June 22, 2020 by Marie Benz MD FAAD