Cara Therapeutics Partner Maruishi Submits Difelikefalin NDA In Japan For Pruritus In Hemodialysis

Cara Therapeutics Inc. (CARA), an early commercial-stage biopharmaceutical company, announced Wednesday that its licensing partner Maruishi Pharmaceutical Co., Ltd. submitted a New Drug Application or NDA in Japan for approval of difelikefalin (KORSUVA) Injection to treat pruritus in hemodialysis patients.

KORSUVA is a kappa opioid receptor agonist developed in Cara laboratories and indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease or CKD-aP in adults undergoing hemodialysis or HD. KORSUVA Injection is not a federally controlled substance.

In was in April 2013 that Cara granted exclusive license to Maruishi to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitles Cara to receive sub-license fees, net of prior payments made by Maruishi to Cara.

Under the deal terms, Cara is eligible to receive milestone payments upon the achievement of defined clinical and regulatory events. It is also eligible for tiered, double-digit royalties with respect to any sales of the licensed product sold in Japan by Maruishi, if any, and share in any sub-license fees.

The NDA includes positive results of a Phase 3 study in Japan, jointly conducted by Maruishi and its sublicensee Kissei Pharmaceutical Co., Ltd. In the trial, 178 patients were administered difelikefalin or placebo for 6 weeks followed by an open-label extension period of difelikefalin administration for 52 weeks. Difelikefalin was well-tolerated in the trial. The primary and the secondary endpoints were significantly improved from baseline compared to the placebo group..

KORSUVA (difelikefalin) injection is approved by the U.S. Food and Drug Administration for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.

Cara's U.S. commercial partner CSL Vifor has launched KORSUVA injection in the U.S. In addition, KORSUVA is approved by Health Canada and the Health Sciences Authority in Singapore.

The drug is also approved by the European Medicines Agency, the UK and many other countries for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients.

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