Eagle Pharmaceuticals recently revealed positive results from its Ryanodex animal study, which was conducted in accordance to the Animal Rule.
The study evaluated Ryanodex for the treatment of Exertional Heat Stroke (EHS), which would be a new indication for the drug.
“We believe that Ryanodex has the potential to offer tremendous value to patients, caregivers and shareholders over a long horizon,” Eagle President and CEO Scott Tarriff said. “Eagle could be the first to market with a potentially life-saving treatment for EHS -- if approved by the FDA -- as early as mid-2017. We are committed to ensuring that the right resources are in place to support the success of the product.”
The results of the study showed that 58.3 percent of treated animals saw a reversal of induced heat stroke/hypermetabolic crisis (HS/HC).
“Positive data from our animal work further supports the efficacy data from our human clinical study, which we completed at the end of 2015,” Eagle Executive Vice President Adrian Hepner said. “The clinical and nonclinical components of our development program provide adequate safety and efficacy data to complete our NDA submission. We anticipate completing the NDA filing as soon as possible.”
