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# Clinical Hold on Cara Therapeutics Pain Drug
- URL: https://www.fdaweb.com/clinical-hold-on-cara-therapeutics-pain-drug/
- Published: 2016-02-26T12:00:00.000Z
- Updated: 2026-09-15T02:38:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134899

> FDA has placed on clinical hold a Cara Therapeutics adaptive pivotal trial of I.V. CR845 for postoperative pain pending a pre-specified safety review. “A protocol-specified stopping rule, based on elevated serum sodium levels greater than 150 mmol/L, was met during the first phase of the study, and a review of unblinded safety data has been undertaken by both Cara and the Independent Data Monitoring Committee (IDMC) in accordance with the protocol,” the company says. It says the safety review’s initial results show:Out of 90 total patients dosed to date, four patients in the highest CR845 dose group (5 ug/kg) exhibited transient serum sodium levels equal to or greater than 150 mmol/L (mild-to-moderate hypernatremia). All four patients were asymptomatic and sodium levels resolved to normal levels (<146 mmol/L) within 24 hours post-dosing with standard fluid management. No patients in the other two dose groups — 2 ug/kg and 1 ug/kg — exhibited serum sodium levels greater than 150 mmol/L.The most common adverse events (> 5%) reported across treatment groups and placebo so far were nausea, hypernatremia, abdominal distension and procedural hypotension. All cases of abdominal distension and procedural hypotension were attributed to the surgical procedure and not to study drug. There were no cases of respiratory depression, no adverse events greater than Grade 1, and no CR845-associated serious adverse events have been reported.  
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> The CLIN3001 study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group adaptive design Phase 3 trial with repeated doses of I.V. CR845 or placebo administered both prior to and following abdominal surgery in male and female patients, according to Cara. The trial is enrolling up to 600 patients undergoing either hysterectomy, prostatectomy, hemi-colectomy or ventral hernia repair at 30 clinical sites within the U.S. Three doses of I.V. CR845 (1.0, 2.0 and 5.0 ug/kg I.V.) are being compared to placebo. The primary efficacy measure is the “change in pain intensity” over the 24-hour postoperative period (AUC-24) using the patient-reported Numeric Rating Scale score collected at pre-specified time points through 24 hours.