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The research progress of opioid peptides from the approval of Difelikefalin

As early as 2021-08-24, Cara Therapeutics and its business partner Vifor Pharma announced that its first-in-class kappa opioid receptor agonist difelikefalin (KORSUVA™) was approved by the FDA for the treatment of chronic kidney disease (CKD) patients (positive Moderate/severe pruritus with hemodialysis treatment), it is expected to be launched in 2022Q1. Cara and Vifor signed an exclusive license agreement for the commercialization of KORSUVA™ in the United States and agreed to sell KORSUVA™ to Fresenius Medical. Among them, Cara and Vifor each have a 60% and 40% profit share in sales revenue other than Fresenius Medical; each has a 50% profit share in sales revenue from Fresenius Medical.

CKD-associated pruritus (CKD-aP) is a generalized pruritus that occurs with high frequency and intensity in CKD patients undergoing dialysis. Pruritus occurs in about 60%-70% of patients receiving dialysis, of which 30%-40% have moderate/severe pruritus, which seriously affects quality of life (eg, poor sleep quality) and is associated with depression. There is no effective treatment for CKD-related pruritus before, and the approval of Difelikefalin helps to address the huge medical need gap. This approval is based on two pivotal Phase III clinical trials in the NDA filing: positive data from the KALM-1 and KALM-2 trials in the U.S. and globally, and supportive data from 32 additional clinical studies, which demonstrate that KORSUVA ™ well tolerated.

Not long ago, good news came from the clinical study of difelikefalin in Japan: 2022-1-10, Cara announced that its partners Maruishi Pharma and Kissey Pharma confirmed that difelikefalin injection is used in Japan for the treatment of pruritus in hemodialysis patients. Phase III clinical trials The primary endpoint was met. 178 patients received 6 weeks of difelikefalin or placebo and participated in a 52-week open-label extension study. The primary endpoint (change in pruritus numerical rating scale score) and secondary endpoint (change in itch score on the Shiratori Severity Scale) were significantly improved from baseline in the difelikefalin group compared with the placebo group and were well tolerated.

Difelikefalin is a class of opioid peptides. Based on this, Peptide Research Institute has studied the literature on opioid peptides, and summarized the difficulties and strategies of opioid peptides in drug development, as well as the current drug development situation.


Post time: Feb-17-2022