FDA grants priority review to Eagle’s NDA for Ryanodex

In January 2014, the company filed its NDA with the FDA for the treatment of malignant hyperthermia, a condition that can be triggered when genetically susceptible individuals come in contact during surgery with certain inhaled anesthetics or the muscle relaxant succinylcholine.

In February 2014, the FDA conditionally accepted its trade name Ryanodex.

Ryanodex has previously been granted Orphan Drug status and the company currently owns three US patents covering the product.

The company plans to commercialize Ryanodex after approval and will retain exclusive marketing rights in the US.

Eagle Pharmaceuticals CEO Scott Tarriff said the company believes that the immediate benefits of its 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," Tarriff said.

"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."

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.