See Why Cara Therapeutics (CARA) Stock Is Moving Higher On Tuesday

The FDA has approved Cara Therapeutics Inc CARA and Vifor Pharma AG’s Korsuva (difelikefalin) injection for severe-to-moderate pruritis (itching) in patients with chronic kidney disease (CKD) undergoing dialysis.
Difelikefalin is an opioid agonist that targets the kappa opioid receptor in the peripheral nervous system.
The companies expect to launch Korsuva in Q1 of 2022 and hope to gain reimbursement and patient access through Medicare and Medicaid in 1H of 2022.
Related content: Benzinga's Full FDA Calendar
The nod was based on two Phase 3 studies of 1,300 CKD dialysis patients with moderate-to-severe pruritis, which showed that 40% and 37% of Korsuva recipients logged a four-point improvement from baseline on a measure of their most severe itch compared to 21% and 26% for those who received placebo.
The drug’s data package included results from an additional 32 trials.
Price Action: CARA shares are up 22.2% at $17.45 during the premarket session on the last check Tuesday.