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Cara’s Phase III Success In CKD-Pruritus Puts NDA Filing In Sight

 
• By Joseph Haas

Second Phase III study expected later this year, but Cara wants to discuss the possibility of accelerated filing with the US FDA. It also has an oral formulation in Phase II for less severe CKD patients.

Young woman suffering from itching on her skin and scratching an itchy place. Allergic reaction to insect bites, dermatitis, food, drugs. Health care concept. Allergy rash - Image
Itching related to CKD is an unmet medical need with no current approved drug therapy (Shutterstock)

Cara Therapeutics Inc. hit the primary endpoint and secondary endpoint along with multiple quality-of-life measures in the first of two Phase III trials for Korsuva, its intravenous therapy for moderate-to-severe pruritus in chronic kidney disease patients on dialysis. The company intends to discuss NDA filing plans with the US Food and Drug Administration later this year while awaiting data from a second pivotal trial.

Analysts called the top-line data from the 350-patient KALM-1 study unveiled on 29 May “a home run” and “significantly de-risking” for the first-in-class, selective kappa opioid receptor agonist

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