- The FDA removes its clinical hold on Cara Therapeutics' (NASDAQ:CARA -5.5%) Phase 3 clinical trial assessing an intravenous formulation of lead product candidate CR845 for the treatment of postoperative pain. The agency instituted the hold last month after elevated serum sodium levels were observed in four patients who received the highest dose of 5 ug/kg.
- Cara's analysis confirmed that the excess sodium levels in the blood were dose-dependent and asymptomatic, with the lowest frequency of events found in the 1 ug/kg cohort. The trial will continue with three arms: 0.5 ug/kg, 1.0 ug/kg and placebo, eliminating the 5 ug/kg dose.
- The study, CLIN3001, will enroll up to 450 patients who have undergone abdominal surgery (e.g., hysterectomy, prostatectomy, hernia repair). The primary endpoint is the change in pain Intensity over 24 hours following surgery as measured by the patient-reported Numeric Rating Scale. Postoperative nausea and vomiting will be assessed as a secondary measure.
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IV CR845, a peripherally acting kappa opioid receptor agonist, is being developed for the treatment of acute and chronic pain. Its value proposition is opioid-like analgesia without the respiratory depression or intestinal tract inhibition (constipation). According to clinicaltrials.gov, the Phase 3's estimated final data collection date for the primary endpoint is this month. The estimated study completion date is June.
- The dose-dependent adverse effect of elevated serum sodium has cooled investors because it potentially constrains IV CR845's efficacy. Shares are off on a 4x surge in volume.
- Previously: FDA halts Cara Therapeutics' late-stage study of lead product candidate for safety review; shares plunge 39% premarket (Feb. 26)