Eagle Pharmaceuticals Inc. said the U.S. Food and Drug Administration granted orphan-drug designation to Ryanodex, 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.
Ryanodex, or dantrolene sodium, is also being developed for treating brain damage secondary to nerve agent exposure. If approved, the drug would be the first treatment for the indication, Eagle Pharmaceuticals said.
Woodcliff Lake, N.J.-based Eagle Pharmaceuticals is developing treatments for oncology, critical care and orphan diseases.