WOODCLIFF LAKE, N.J.—Eagle Pharmaceuticals Inc. announced this summer that the U.S. Food and Drug Administration (FDA) had approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. The FDA had designated Ryanodex as an Orphan Drug in August 2013.
“We are very pleased with today’s approval of Ryanodex, which enables healthcare providers to better meet the needs of patients experiencing a life-threatening MH crisis,” said Scott Tarriff, CEO of Eagle Pharmaceuticals. “This significant milestone exemplifies our strategy of developing innovative products.”
Ryanodex reportedly represents the first product to be solely marketed by the company.
Ryanodex is the first significant enhancement to MH treatment options in more than three decades, reformulated to improve performance in managing MH. The product has the potential to become a new standard of care for the treatment of malignant hyperthermia, Eagle says, because it enables anesthesiologists to deliver a therapeutic dose of the only antidote for MH (dantrolene sodium) in a much more expedient manner than currently possible with existing formulations of IV dantrolene sodium, potentially saving lives and reducing MH-related morbidity. Ryanodex can be prepared and administered in less than one minute by a single healthcare practitioner.
“When a patient experiences malignant hyperthermia during surgery, it is a life-threatening emergency requiring immediate treatment, including the administration of the ‘antidote’ drug dantrolene sodium,” said Dr. Henry Rosenberg, a founder and president of the Malignant Hyperthermia Association of the United States. “The ability for healthcare professionals in hospitals and surgery centers to more quickly prepare and administer this new formulation of the antidote dantrolene sodium is expected to bring the crisis under control more rapidly and prevent severe complications from MH.”