Eagle Pharmaceuticals today announced that the U. S. Food and Drug Administration (FDA) has 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. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.
“We are very pleased with today’s approval of Ryanodex, which enables health care 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 and we plan to ship the product in the very near future.”
Eagle is the exclusive licensee of four U.S. patents for Ryanodex. Approval of Ryanodex represents two major milestones: in addition to adding to the Company’s portfolio of approved compounds, Ryanodex 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, 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.
Utilizing innovative nanosuspension technology, Ryanodex now provides a therapeutic loading dose of dantrolene sodium in a single vial. 250 mg of Ryanodex is mixed with only 5 mL of sterile water and administered to the patient in less than one minute. Other dantrolene sodium formulations require multiple 20mg vials reconstituted in large volumes of sterile water, a process that can take 15 to 20 minutes to mix reconstitute and administer.
“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 Henry Rosenberg, MD, CPE, a founder and President of the Malignant Hyperthermia Association of the United States (MHAUS). “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.”
Ryanodex was granted priority review status by the FDA in March 2014, a regulatory review process that expedites the review of drugs that treat life threatening and serious conditions and provide a significant improvement in safety or effectiveness over the existing therapies. Ryanodex will be available to order through national and regional drug wholesalers in August with product shipping shortly after.