The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) of Ryanodex (dantrolene sodium; Eagle) for the treatment of exertional heat stroke (EHS).
The NDA submission for Ryanodex is based on preclinical data from animal studies and safety and efficacy data from a controlled clinical trial in patients with EHS. The studies supported its known and well-characterized safety profile and showed increased clinically meaningful effectiveness, when added to body cooling, in the treatment of EHS compared to body cooling alone.
Currently, there is no approved pharmacologic treatment for EHS; treatment is limited to body cooling by physical methods (eg, water immersion, ice-packs, water misting), and supportive measures including IV fluids and respiratory support. If approved, Ryanodex will become the first drug therapy for this life-threatening medical emergency. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of July 23, 2017 to complete the NDA review.
Ryanodex, a skeletal muscle relaxant, is a unique formulation of dantrolene and is currently indicated for the treatment of malignant hyperthermia (MH) in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.
For more information call (201) 326-5300 or visit Eagleus.com.