Eagle Pharmaceuticals announces results from RYANODEX study
Eagle Pharmaceuticals announced positive results of its study to evaluate the neuroprotective effects of RYANODEX, or dantrolene sodium, secondary to nerve agent exposure, conducted with the U.S. Army Medical Research Institute of Chemical Defense, or USAMRICD. The study results show a p-value of 0.04 or less compared to the control group in six critical areas of the brain. We believe these results demonstrate the neuroprotective effects of RYANODEX. It has been hypothesized that nerve agent poisoning triggers intracellular calcium release in the body. The study data supports the proposed mechanism of action of RYANODEX, which modulates intracellular calcium in different organs including the brain. "We intend to meet with the FDA to discuss next steps as soon as possible. Given the life-threatening nature of NA exposure, we believe this indication would be evaluated under the FDA's Animal Rule. If approved, this would be an additional indication for RYANODEX, as we continue to develop additional potential indications and an intramuscular formulation of the drug," said the company.