STAMFORD, Conn., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd.

康涅狄格州斯坦福德，2023年9月25日（GLOBE NEWSWIRE）-Cara Therapeutics，Inc。（纳斯达克股票代码：Cara），一家商业阶段的生物制药公司，领导一种新的治疗模式，以改善患有瘙痒症的患者的生活，今天宣布其许可合作伙伴Maruishi Pharmaceutical Co.，Ltd。

received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA® IV Injection Syringe for the treatment of pruritus in hemodialysis patients. Cara earned a $1.5 million milestone payment upon approval, per the terms of the licensing agreement. “We are pleased that our first-in-class therapy KORSUVA injection will be available to hemodialysis patients in Japan who are suffering from pruritus,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics.

获得日本厚生劳动省的KORSUVA®IV注射注射器制造和销售批准，用于治疗血液透析患者的瘙痒。根据许可协议的条款，Cara经批准获得150万美元的里程碑付款。Cara Therapeutics总裁兼首席执行官克里斯托弗·波斯纳（Christopher Posner）说：“我们很高兴我们的一流疗法KORSUVA注射液可用于日本患有瘙痒的血液透析患者。

“As we work toward establishing Cara Therapeutics as the leader in the treatment of chronic pruritus, we will continue to collaborate with our partners to address the significant unmet need for an effective antipruritic treatment for chronic kidney disease patients undergoing hemodialysis worldwide.” The approval is based on positive results of a Phase 3 clinical trial in Japan, which was jointly conducted by Maruishi and its sublicensee Kissei Pharmaceutical Co., Ltd.

“当我们致力于建立Cara治疗药物作为治疗慢性瘙痒症的领导者时，我们将继续与我们的合作伙伴合作，解决全球血液透析慢性肾病患者有效止痒治疗的重大需求。”批准是基于日本3期临床试验的积极结果，由Maruishi及其子许可证Kissei制药有限公司联合进行。

In the trial, 178 patients were administered KORSUVA or placebo for 6 weeks followed by an open-label extension period of KORSUVA administration for 52 weeks. The primary endpoint, change in itch Numerical Rating Scale score, and the secondary endpoint, change in itching scores of Shiratori severity criteria, were significantly improved from baseline compared to the placebo group and KORSUVA was well-tolerated.

在该试验中，178名患者接受了KORSUVA或安慰剂治疗6周，随后进行了KORSUVA治疗的开放标签延长期52周。与安慰剂组相比，主要终点，瘙痒数字评定量表评分的变化和次要终点，Shiratori严重程度标准的瘙痒评分的变化从基线显着改善，并且KORSUVA耐受性良好。

KORSUVA is approved by the U.S. Food and Drug Administration for the treatmen.

KORSUVA被美国食品和药物管理局批准用于治疗。