FDANews
FDAnews Drug Daily Bulletin

FDA Orders Halt of Cara’s Postoperative Pain Clinical Trial

March 4, 2016

The FDA has placed a clinical hold on Cara Therapeutics’ Phase 3 trial of I.V. CR845 for postoperative pain because elevated serum sodium levels were seen in some patients.

According to Cara, the decision was based on a protocol-specified stopping rule based on levels greater than 150 mmol/L. Four patients in the highest dose group showed transient serum sodium levels equal to or greater than 150 mmol/L. The drugmaker noted that the patients were asymptomatic and their sodium levels returned to normal.

Company CEO Derek Chalmers says Cara is working with the FDA to review patient safety data and resolve the issue. Cara added that the independent data monitoring committee also is reviewing the data.