CARA - Cara Therapeutics submits new drug application for antipruritic therapy

Cara Therapeutics (CARA) has submitted a New Drug Application to the FDA for KORSUVA™ Injection (difelikefalin) for the treatment of moderate-to-severe pruritus in hemodialysis patients.KORSUVA has the FDA's Breakthrough Therapy Designation for the indication, and with Priority Review requested for the NDA, the review process will take six months, the company said. However, the regulator has a 60-day filing review period to determine if the submission is complete and acceptable for filing.The NDA request is supported by positive data from two pivotal Phase 3 trials: the KALM-1 trial conducted in the U.S. and the globally-run KALM-2 trial.Chronic Kidney Disease-Associated Pruritus is a systemic itch condition suffered by patients with chronic kidney disease undergoing dialysis. Many dialysis patients (60 - 70%) experience pruritus, with 30 - 40% cases reported as moderate or severe.“We look forward to working with the FDA through the review process and, along with our commercial partner, Vifor Pharma, remain

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Cara Therapeutics submits new drug application for antipruritic therapy