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news.The US Food and Drug Administration (FDA) has approved Eagle Pharmaceuticals' Ryanodex (dantrolene sodium) for injectable suspension to treat malignant hyperthermia (MH), along with the appropriate supportive measures.
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Malignant hyperthermia is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals.
The FDA had granted orphan drug designated to Ryanodex in August 2013.
The company has been informed by the FDA that it will get to know over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.
Eagle Pharmaceuticals CEO Scott Tarriff said the company is happy with the approval of Ryanodex, which allows health care providers to better meet the needs of patients experiencing a life-threatening MH crisis.
"This significant milestone exemplifies our strategy of developing innovative products and we plan to ship the product in the very near future," Tarriff said.
The company is the exclusive licensee of four US patents for Ryanodex.
Malignant Hyperthermia Association of the United States (MHAUS) founder and president Henry Rosenberg said 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.
"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," Rosenberg said.
In March 2014, Ryanodex had secured granted priority review status by the US FDA.
The company said that the drug will be available to order through national and regional drug wholesalers in August 2014 with product shipping shortly after.