FDA to Review Drug for Exertional Heat Stroke
Eagle announced the complete submission to the Food and Drug Administration (FDA) of its New Drug Application (NDA) for Ryanodex for the treatment of exertional heat stroke (EHS).
EHS is a life threatening medical emergency, presenting as a sudden and unpredictable heat-related disorder with the potential for severe multi-organ dysfunction and death. It is commonly seen in young people undergoing exertional physical activity in a hot weather environment, including athletes, military personnel, and other active individuals. 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.
The NDA submission for Ryanodex is based on data from animal studies completed in December 2016 and a clinical trial in EHS patients completed after the Hajj pilgrimage in 2015. 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.
Eagle has requested Priority Review for the Ryanodex NDA. If granted, a Prescription Drug User Fee Act (PDUFA) date for a decision on the NDA would be July 2017; otherwise the Company anticipates approval later in 2017.
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.
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