March 19, 2014
Eagle Pharmaceuticals, Inc. announced today that the United States Food and Drug Administration has accepted the company’s New Drug Application for Ryanodex® (dantrolene) and granted a priority review classification. The PDUFA date is July 22, 2014.
In January 2014, Eagle filed its NDA with the FDA for the treatment of malignant hyperthermia. In February 2014, the FDA conditionally accepted Eagle’s trade name Ryanodex. Ryanodex has previously been granted Orphan Drug designation and Eagle currently owns three U.S. patents covering the product. Eagle intends to commercialize Ryanodex after approval and will retain exclusive marketing rights in the U.S.
Scott Tarriff, CEO of Eagle Pharmaceuticals, said, “We believe that the immediate benefits of our improved and more concentrated formulation can be clinically significant in critical care situations. Each vial of Ryanodex is reconstituted in less than one minute by the anesthesiologist in contrast to the need to mix and administer approximately 12 vials of currently marketed products. This reduction in the time to treat patients can result in notable improvement in patient outcomes. Additionally, the currently marketed formulation requires significant drug product volume to be administered. Eagles’ Ryanodex formulation has reduced the required volume by more than 95% for an equivalent dose.”
About Malignant Hyperthermia
Malignant Hyperthermia is a condition that can be triggered when genetically susceptible individuals come in contact during surgery with certain inhaled anesthetics or the muscle relaxant succinylcholine. These patients can experience tachycardia, elevated blood pressure, raised CO2 levels and very high body temperature levels. If not treated immediately, the hyper-metabolic episode can be fatal to the patient.
See the press release here.