FDA approves Eagle's Ryanodex for malignant hyperthermia
FDA approved an NDA from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) for Ryanodex dantrolene to treat malignant hyperthermia. The company said it plans to launch the drug next month at a wholesale acquisition cost of $2,300 for a 250 mg vial. Eagle told BioCentury that one vial of Ryanodex "is sufficient to provide a loading dose for patients up to 100 kg. The average total dosage required to treat a patient during an MH episode typically requires one-to-three vials, depending on the patient's weight and condition severity."
Ryanodex is a lyophilized formulation of the muscle relaxant dantrolene, which reverses the signs of malignant hyperthermia. Eagle said Ryanodex can be reconstituted in less than one minute compared to the 15-20 minutes required for marketed formulations of dantrolene. ...