Eagle Pharmaceuticals Inc. resubmitted a new drug application with the U.S. Food and Drug Administration seeking approval of Ryanodex to treat exertional heatstroke.
The agency is expected to give its decision six months from the submission, Eagle Pharmaceuticals said in a Jan. 9 press release.
The U.S. regulator rejected an earlier application for Ryanodex to treat exertional heatstroke, which is characterized by elevated core body temperature and can trigger sudden behavioral changes, seizures or coma. Headache and hyperthermia are the key initial symptoms of exertional heatstroke.
The Woodcliff Lake, N.J.-based biotechnology company, which develops injectable products in critical care and cancer treatment in the U.S., was asked in July 2017 by the FDA to conduct an additional clinical trial to evaluate Ryanodex for the same indication.
Ryanodex was recently granted orphan-drug designation by the U.S. regulator for its potential treatment of organophosphate exposure. Organophosphates are chemical substances used in potent pesticides and chemical weapons known as nerve agents. According to the U.S. Centers for Disease Control and Prevention, organophosphates are the most widely used insecticides today. Acute intoxication with organophosphates could lead to brain damage and death.
The drug is already approved for treating malignant hyperthermia in conjunction with appropriate supportive measures and for malignant hyperthermia in patients at high risk.