Difelikefalin New Drug Application Submitted in Japan for Treatment of Pruritus in Hemodialysis Patients

Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa; "Kissei") and Maruishi Pharmaceutical Co., Ltd. (Head Office: Tsurumi, Osaka, Representative Director and President: Katsuhito Inoue; "Maruishi") today announced that Maruishi has submitted a new drug application for approval of manufacturing and marketing in Japan for Difelikefalin (generic name, Development Code: MR13A9) for the treatment of pruritus in hemodialysis patients.

Difelikefalin is a kappa opioid receptor agonist originated and developed by Cara Therapeutics, Inc. (Head Office: USA, President and CEO: Christopher Posner; "Cara"), and is the first intravenous formulation product in the world for the treatment of pruritus in hemodialysis patients. It was approved by the US Food and Drug Administration in August 2021 and European Commission in April 2022 for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. In April 2013, Maruishi acquired the development and commercialization rights for acute pain and uremic pruritus in Japan, and since March 2017, Maruishi and Kissei have been jointly developing difelikefalin for the indication of uremic pruritus in Japan.

Kissei and Maruishi strive to expand treatment options for uremic pruritus to contribute to improving QOL (Quality of Life) of patients on dialysis.

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About uremic pruritus in dialysis patients
Uremic pruritus is a common itching condition in spite of the absence of obvious skin lesion, which occurs in many patients with end-stage renal disease undergoing hemodialysis.
It is reported that long-lasting and intense distressing itching in these patients make their QOL very low and have negative impacts on psychological and physical health such as poor sleep quality, depression, and an increased risk of death.

About Difelikefalin (generic name, Development Code: MR13A9)
Difelikefalin is a new compound originated and developed by Cara Therapeutics, Inc. and is a selective kappa opioid receptor (KOR) agonist. It is considered that endogenous opioids are related to pruritus as one of the expression mechanisms of pruritus in dialysis patients. Difelikefalin selectively activates KOR which is one of the subtypes of opioid receptors, and is expected to suppress pruritus.

About Kissei Pharmaceutical Co., Ltd.
Kissei is a Japanese pharmaceutical company based on the management philosophy "contributing to society through high-quality, innovative pharmaceutical products" and "serving society through our employees." As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynecology and rare/intractable diseases.
For more details about Kissei Pharmaceutical Co., Ltd., please visit https://www.kissei.co.jp/

About Maruishi Pharmaceutical Co., Ltd.
Maruishi is a specialty pharma that has a strong presence in the perioperative and infection control area, and is known as a leading producer of Japanese Pharmacopoeia drugs. Making use of the technology, knowledge, and know-how that have been cultivated over 130 years of history, Maruishi continues to contribute to the healthcare and improvement of QOL of the patients.
For more details about Maruishi Pharmaceutical Co., Ltd., please visit https://www.maruishi-pharm.co.jp/

About Cara Therapeutics, Inc.
Cara Therapeutics (Nasdaq: CARA) is a commercial-stage biopharmaceutical company leading a new treatment to improve the lives of patients suffering from pruritus.
For more information, visit https://www.caratherapeutics.com and follow the company on Twitter, LinkedIn and Instagram.