Drug approved to treat malignant hyperthermia
Can be prepared in less than 1 minute by 1 person
The Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) from Eagle Pharmaceuticals in Woodcliff Lake, NJ, for injectable suspension indicated for the treatment of malignant hyperthermia (MH). Ryanodex can be prepared and administered in less than one minute by a single healthcare practitioner.
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. At press time, Eagle said it has been informed by the FDA that it will learn over the next few weeks if it has been granted the seven-year orphan drug market exclusivity.
"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 is the first significant enhancement to MH treatment options in more than three decades, and it has been 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 possible with existing formulations of IV dantrolene sodium.
Malignant hyperthermia is an inherited genetic disorder found in an estimated one out of 2,000 people. MH crisis situations are triggered by commonly used general anesthetics and the paralyzing agent, succinylcholine, and result in a biochemical chain reaction response in the skeletal muscles of susceptible individuals. General signs of MH crisis include increased heart rate, greatly increased body metabolism, muscle rigidity, and/or fever that may exceed 110 degrees Fahrenheit along with muscle breakdown. MH crisis mortality is extremely high without immediate recognition and treatment with the antidote, dantrolene sodium.
MHAUS provides information and resources to medical and lay communities through conferences, educational materials, ID tags, a 24-hour MH Hotline (800-644-9737), and the MHAUS website: http://www.mhaus.org.