Breakthrough itch therapy submits new drug applications for priority review

Cara Therapeutics today announced that it has submitted a new drug application (NDA) for Korsuva injections to the FDA to treat severe itching in patients with hemodialysis.
Korsuva is a small molecular inhibitor that selectively targets exosome opioids (KORs).
it has been recognized as a breakthrough therapy awarded by the FDA.
cara has requested a priority review of the NDA, which, if approved, could be shortened to six months.
associated with chronic kidney disease (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 do not receive 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.
currently used for these patients with major treatment options such as antihistamines and corticosteroids, 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-subjected exciterant.
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: Edgar181), Public domain, via Wikimedia Commons, an NDA submission 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 controlled group of phase 3 clinical trials KALM-2, 54 percent of patients in the treatment group had a 24-hour itching intensity numeric scale (WI-NRS) score reduced by 3 points or more during 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 "Korsuva injection" is an important milestone for hemodialysis patients with stubborn 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.
: 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