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Chronic renal disease-related itching (CKD-aP) is a stubborn, systemic itching disorder that occurs mostly in CKD patients receiving hemodialysis and peritina dialysis.
stage III-V CKD patients who have not received dialysis treatment also have itching.
comprehensive longitudinal multi-country study, it is estimated that about 60%-70% of dialysis patients will develop itching, of which 30% to 40% are moderate to severe itching.
itch treatments, such as antihistamines and corticosteroids, are currently used for these patients, but they do not provide consistent and adequate relief.
severe chronic itching can have a direct impact on the quality of life of patients, such as poor sleep quality, and may even lead to depression.
Korsuva is a highly selective exosome opioid-sensitive excitant.
it has strong analgesic, anti-inflammatory and anti-itching effects in both humans and animals.
Because Korsuva performs poorly in penetrating the blood-brain barrier, it has little or no central nervous system (CNS)-mediated side effects such as nausea, vomiting, sedation, respiratory suppression, abuse, addiction, or euphoria.
Difelikefalin Molecular Structure (Photo: Edgar 181), Public domain, via Wikimedia Commons, this NDA submission is supported by positive data from two key Phase 3 clinical trials, including the KALM-1 trial in the United States and the global KALM-2 trial, as well as support data from 32 other clinical studies.
In the randomized double-blind, placebo-containing control group of Phase 3 clinical trial KALM-2, 54 percent of patients in the treatment group had a 24-hour daily itching intensity numeric scale (WI-NRS) score reduced by 3 points or more in the 12th week of treatment, compared with 42 percent of patients in the placebo group who reached this level, reaching the primary endpoint of the trial.
in addition, 41 percent of patients in the treatment group had WI-NRS scores that improved by 4 points or more compared to the baseline, and only 28 percent of patients in the placebo group achieved this level, reaching a critical secondary endpoint of the trial.
submission of the NDA for the Korsuva injection is an important milestone for hemodialysis patients with persistent itching.
Derek Chalmers, President and CEO of Cara Therapeutics, said, "We look forward to continuing to work with the FDA during the review process."
if approved, we will continue to focus on preparing for the launch of Korsuva injections with our commercial partner Vifor Pharma.
: This article is intended to introduce medical and health research, not treatment options recommended.
if you need guidance on treatment options, visit a regular hospital.
: s1. Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus. Retrieved December 28, 2020, from