Cara’s pruritus therapy headed for submission after second Phase III readout

New Phase III data for its lead program will be part of Cara’s planned NDA submission this year of Korsuva to treat pruritus associated with chronic kidney disease. President and CEO Derek Chalmers said on a conference call Tuesday that the company will seek Priority Review from FDA.

Cara Therapeutics Inc. (NASDAQ:CARA) said Tuesday that injectable Korsuva difelikefalin met the primary endpoint in KALM-2, a global Phase III trial in dialysis-dependent patients with moderate to severe CKD. The results follow last year’s readout from the U.S. Phase III KALM-1 trial, in which the KOR agonist also met the primary endpoint...