Eagle to meet with FDA to discuss Ryanodex exertional heat stroke data

Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) said it plans to meet with FDA to discuss next steps for Ryanodex dantrolene to treat exertional heat stroke after the candidate improved neurologic function in three of four patients in a Phase III trial conducted in August.

In July 2017, Eagle received a complete response letter from FDA requesting an additional trial for Ryanodex in the indication. That submission was based on a Phase III trial conducted in September 2015 that enrolled 34 patients at emergency rooms in Saudi Arabia during the Hajj pilgrimage. The 2015 trial showed that Ryanodex plus standard of care (SOC) body cooling methods led to a Glasgow Coma Score (GCS) of at least 13 points in 29.4% of patients within 90 minutes after randomization and in 47.1% of patients within 24 hours vs. 11.8% and 23.5% of patients who received SOC alone, respectively (see “Eagle Gets CRL for Ryanodex”)...