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CCARA THERAPEUTICS Cara Therapeutics Reports Second Quarter 2021 Financial Results August 9 , 2021 - New Drug Application ( NDA ) Filing for KORSUVATM Injection in CKD - aP under Priority Review byU.S. Food and Drug Administration ( FDA ) ; PDUFA Target Action Date August 23 , 2021 - - Conference call today at 4:30 p.m. ET STAMFORD , Conn . , Aug. 09 , 2021 ( GLOBE NEWSWIRE ) -- Cara Therapeutics , Inc. ( Nasdaq : CARA ) , a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors ( KORS ) , today announced financial results and operational highlights for the second quarter ended June 30 , 2021 . " Having completed the late - cycle review of our NDA for our lead asset KORSUVAT Injection with the FDA during the second quarter of the year , we remain on track for an expected Prescription Drug User Fee Act ( PDUFA ) target action date of August 23 , 2021 and continue to be focused , along with our commercial partner , Vifor Pharma , on preparation for the U.S. launch of KORSUVA Injection in the second half of 2021 , if approved , " said Derek Chalmers , Ph.D. , D.Sc. , President and Chief Executive Officer of Cara Therapeutics . " We also continue to make good progress in our Oral KORSUVA programs across a range of patient populations where pruritus treatment remains a significant unmet need and , pending the outcome of our scheduled End - of - Phase 2 meeting with the FDA , aim to initiate our first Oral KORSUVA Phase 3 program in mild - to - moderate atopic dermatitis patients by year - end of 2021. " Second Quarter and Recent Developments : KORSUVA Injection : Chronic Kidney Disease - Associated Pruritus ( CKD - aP ) : Hemodialysis In February 2021 , the FDA accepted the filing of the NDA for KORSUVA Injection for the treatment of moderate - to - severe pruritus in hemodialysis patients . Shortly after this decision , the FDA granted Priority Review for the NDA filing of KORSUVA Injection in March 2021 with an expected PDUFA target action date of August 23 , 2021. Following these decisions , the potential FDA approval and subsequent U.S. commercial launch of KORSUVA Injection could take place in the second half of 2021. If approved , KORSUVA Injection would be the first treatment for CKD - aP in hemodialysis patients . In March 2021 , the Company and Vifor Fresenius Medical Care Renal Pharma Ltd. ( VFMCRP ) announced that the European Medicines Agency ( EMA ) accepted to review the Marketing Authorization Application ( MAA ) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients . The EMA will review the application under the centralized marketing authorization procedure . If approved , difelikefalin injection would receive marketing authorization in all member states of the European Union ( EU ) , as well as in Iceland , Liechtenstein , and Norway . The EMA is expected to render a decision on the EU MAA in the second quarter of 2022 . The Company is party to a license agreement with Vifor ( International ) Ltd. ( Vifor ) dated October 2020 under which it granted Vifor an exclusive license to commercialize KORSUVA Injection for the treatment of pruritus in hemodialysis patients in the United States under a Cara 60 % , Vifor 40 % profit - sharing arrangement . Under the terms of the agreement , upon U.S. regulatory approval of KORSUVA Injection , the Company will be eligible to receive a $ 50.0 million common stock investment at a 20 % premium to the 30 - day trailing average price of the Company's common stock as of such date . In addition , the Company is eligible to receive payments of up to $ 240.0 million upon the achievement of certain sales - based milestones . Oral KORSUVA : Atopic Dermatitis ( AD ) In April 2021 , the Company announced top - line results from its Phase 2 KARE dose - ranging clinical trial of Oral KORSUVA for the treatment of moderate - to - severe pruritus in mild - to - severe atopic dermatitis patients . The study did not meet its primary endpoint of Worst Itch - Numeric Rating Scale ( WI - NRS ) change from baseline at week 12 or secondary endpoint of 4 - point responder analysis in the intent to treat ( ITT ) patient population . However , in a pre - specifie analysis of mild - to - moderate ( BSA < 10 % ) AD patients ( 64 % of ITT patie opulation ) , the study met its primary endpoint of WI - NRS chang and secondary endpoint of 4 - point responder analysis in this patient population . Additionally , a statistically significant improvement was demonstrated in the 4 - point responder analysis , which we expect will be the Phase 3 registrational endpoint , in mild - to - moderate AD patients , with 32 % of KORSUVA - treated patients achieving a greater than 4 - point reduction vs. 19 % in placebo group ( p = 0.03 ) . Oral KORSUVA was generally well - tolerated across all doses . The Company is scheduled to conduct an End of Phase 2 Meeting with the FDA in the third quarter of 2021 and , subject to discussions with the FDA , plans to initiate a Phase 3 program in mild - to - moderate AD patients by year - end 2021 . Oral KORSUVA : Non - Dialysis Dependent ( NDD ) CKD - aP In April 2021 , the Company held an End of Phase 2 Meeting with the FDA to discuss the results of the Phase 2 trial of Oral KORSUVA in NDD CKD - aP and the potential Phase 3 program . The FDA indicated the acceptability of Stage 5 pre - dialysis CKD patients as a viable patient population for a Phase 3 trial . The FDA also indicated the potential to use data from the Company's previous trials of KORSUVA Injection in dialysis patients to support an approval based on a single Phase 3 clinical trial of Oral KORSUVA in the Stage 5 pre - dialysis population . The Company plans to meet with the FDA in the fourth quarter of 2021 , to discuss the potential inclusion of earlier stage CKD patients in a Phase 3 program . Oral KORSUVA : Chronic Liver Disease - Associated Pruritus ( CLD - aP ) : Primary Biliary Cholangitis ( PBC ) The Company is currently conducting a Phase 2 trial of Oral KORSUVA for the treatment of pruritus in patients with hepatic impairment due to PBC . The trial is evaluating the safety and efficacy of Oral KORSUVA ( 1.0 mg tablet , twice daily ) versus placebo for 16 weeks . The Company continues to screen patients in this ongoing Phase 2 trial , and primarily due to the ongoing effects of the COVID - 19 pandemic on patient enrollment , currently expects to report top - line data in the first half of 2022 . Oral KORSUVA : Notalgia Paresthetica ( NP ) The Company initiated a Phase 2 trial of Oral KORSUVA for the treatment of moderate - to - severe pruritus in patients suffering from NP , a nerve disorder characterized by chronic pruritus of the upper back , in early 2021. Currently , the Phase 2 trial has exceeded 50 % patient enrollment and is expected to be fully enrolled by year - end 2021 . The Phase 2 multicenter , randomized , double - blind , placebo - controlled 8 - week study is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate - to - severe pruritus in approximately 120 subjects with NP . Subjects will be randomized to receive Oral KORSUVA 2.0 mg twice daily versus placebo for 8 weeks , followed by a 4 - week active extension period . The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24 - hour WI - NRS score at week 8 of the treatment period . Secondary endpoints include change from baseline in itch - related quality of life scores and a change from baseline in itch - related sleep disturbance subscale at the end of week 8 . COVID - 19 Impacts and Business Operations Due to the ongoing COVID - 19 pandemic and in accordance with the FDA's updated guidance for conducting clinical trials , the Company has implemented numerous clinical and operational measures to prioritize the health and safety of patients , employees and study investigators and minimize potential disruptions to its ongoing clinical studies . The Company is working closely with its clinical and commercial manufacturing partners to continue to ensure sufficient supply of KORSUVA is available for its ongoing and planned clinical trials . Based on guidelines from the Centers for Disease Control and Prevention and the State of Connecticut , all Cara employees continue to work remotely , and business travel has been restricted . Upcoming Meeting Activities The Company expects to make presentations at the following upcoming conferences : • Cantor Fitzgerald Global Healthcare Conference , September 27-30 , 2021 . Stifel Healthcare Conference , November 16-17 , 2021 • Jefferies Global Healthcare Conference , November 16-18 , 2021