FDA Grants Priority Review Designation for Exertional Heat Stroke Drug

Amy Jacob

FDA gives priority review designation for exertional heat stroke drug.

The US Food and Drug Administration (FDA) today awarded priority review designation for the New Drug Application (NDA) for dantrolene sodium (Ryanodex/Eagle Pharmaceuticals) to treat exertional heat stroke (EHS), a condition associated with high core body temperatures (greater than 104°F).

There currently are no approved and/or available pharmacological treatments, as such, researchers advise treating EHS by cooling the body with physical methods: water immersion, ice-packs, and water misting.

Officials had already granted Ryanodex fast track designation in February, and if approved, Ryanodex, would be the first drug therapy for EHS.

Researchers reported that the high core temperatures of EHS could put the brain and other vital organs at risk for permanent damage or may even cause death. While the condition can impact anyone regardless of age or physical ability, athletes, firefighters, and members of the military are often considered particularly vulnerable.

The NDA was supported by safety and efficacy data about Ryanodex from a controlled clinical trial in EHS patients as well as preclinical data from animal studies. According to the results, compared to body cooling methods alone, combining Ryanodex to body cooling showed significant evidence of “clinically meaningful effectiveness in treating patients with EHS”.

Under the Prescription Drug User Fee Act (PDUFA), FDA officials aim to complete its review within 6 months of the NDA, which had been scheduled for July 23, 2017.