An investigational therapy in development for the treatment of exertional heat stroke (EHS) has been placed on a fast-track development pathway by the US Food and Drug Administration, in the hope of accelerating access to the first drug for the potentially fatal condition.
EHS is a rare, sudden and unpredictable disorder that can result in severe multi-organ dysfunction and death, characterised by core body temperature of 104° F (40° C) or greater and significant neurological dysfunction.
The condition is more commonly seen in young people undergoing exertional physical activity in a hot weather environment, and is a leading cause of death in young athletes. However, there remains a very high level of unmet need given that there is no approved medicine available to treat EHS.
Eagle Pharmaceuticals is developing its injectable suspension Ryanodex (dantrolene sodium) - which is already on the market for malignant hyperthermia - for the treatment of EHS after it showed positive signs of safety and efficacy in clinical trials.
The firm says it is “encouraged” by the FDA’s fast-track designation, which “is an acknowledgement of the seriousness of EHS and the current lack of a drug treatment”.