Cara Therapeutics Submits New Drug Application to U.S. FDA for KORSUVA™ Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus

• First NDA submission for Company’s lead program, KORSUVA™ Injection –
• NDA submission includes request for Priority Review under Breakthrough Therapy Designation for KORSUVA Injection –

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, or KORs, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for KORSUVA™ Injection (difelikefalin) for the treatment of moderate-to-severe pruritus in hemodialysis patients. KORSUVA Injection received Breakthrough Therapy Designation from the FDA for this indication. Cara has requested Priority Review for the NDA which, if granted, could result in a six-month review process. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.

The NDA submission is supported by positive data from two pivotal Phase 3 trials of KORSUVA Injection, including the KALM-1 trial conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232) and the global KALM-2 trial, as well as supportive data from an additional 32 clinical studies.

“The NDA submission for KORSUVA Injection marks a significant milestone for Cara and for hemodialysis patients who suffer from intractable pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “I’d like to thank the entire Cara team for working tirelessly to bring this first-in-class therapeutic from in-house discovery, through development to the completion of NDA submission, as well as the patients, investigators and site personnel who participated in the clinical trials. We look forward to working with the FDA through the review process and, along with our commercial partner, Vifor Pharma, remain focused on preparation for the U.S. launch of KORSUVA Injection, if approved.”

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