Eagle Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Fast Track designation to its Ryanodex (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (“EHS”), an investigational new indication for the product.
The FDA’s Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need. A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval to get important new drugs to the patient earlier.
“We are very 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. EHS is a leading cause of death in young athletes and non-combat related fatalities in the military, yet no drug products exist on the market today to treat this devastating and potentially fatal condition. This Fast Track designation will enable us to work more closely w
ith the FDA and expedite our program to make RYANODEX available to medical practitioners, and potentially expand the product’s label to include EHS as an authorized second indication,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
About Exertional Heat Stroke
Exertional Heat Stroke is a rare, sudden and unpredictable disorder that constitutes a medical emergency which may result in severe multi-organ dysfunction and death. EHS is more commonly seen in young people undergoing exertional physical activity in a hot weather environment, and is one of the leading causes of death in young athletes. EHS cases are also observed in construction workers, firefighters, military personnel and farmers. There is no currently approved drug product for the treatment of EHS.
Eagle Pharmaceuticals
eagleus.com
