Cara modifying pain trial after FDA lifts clinical hold

Cara Therapeutics Inc. (NASDAQ:CARA) said it expects to resume enrollment next month in the Phase III CLIN3001 trial of IV CR845 to treat acute postoperative pain after FDA removed a clinical hold on the study. The company now plans to use lower doses of the long-acting peripheral kappa opioid receptor ( KOR; OPRK1) agonist.

FDA placed the hold in February after four of 22 patients treated with 5 ug/kg of CR845, the study's highest dose, had serum sodium levels of at least 150 mmol/L, triggering a protocol-specified stopping rule (see BioCentury Extra, Feb. 25). ...