Cara’s Korsuva Impresses Against Pruritus In Hemodialysis Patients
Pivotal KALM-2 Study Meets Primary Endpoint
Cara Therapeutics and licensee Vifor Pharma have released positive topline data from the KALM-2 study in chronic kidney disease patients with moderate-to-severe pruritus undergoing hemodialysis, using a first-in-class selective kappa opioid receptor agonist which does not enter the CNS.
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The kappa opioid receptor agonist is not listed as a scheduled substance and labeling meets expectations. Cara and partner Vifor plan to launch the product in early 2022.
I.V. Korsuva now has an August FDA action date, which partner Vifor would commercialize in the ESRD dialysis setting while Cara works toward a broad anti-pruritus label for its oral tablet formulation.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.