Newswise — Eagle Pharmaceuticals, Inc. today announced 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.
The Malignant Hyperthermia Association of the United States (MHAUS) is pleased to share this, and any new treatment options as they become available, with the heallthcare professionals and their patients whom we assist in order to effect a positive outcome when an unexpected MH event occurs.
“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.”
MHAUS will discuss today’s announcement at a planned meeting this fall on how the administration of Ryanodex might affect the current Emergency Therapy for Malignant Hyperthermia now being used in ambulatory surgery centers, hospitals, and office based surgery suites.
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.
About Malignant Hyperthermia
Malignant Hyperthermia is an inherited genetic disorder found in an estimated 1 out of 2,000 people. MH crisis situations are triggered by commonly used general anesthetics and the paralyzing agent, succinylcholine, and results 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° F along with muscle breakdown. Without proper and prompt treatment, MH crisis mortality is extremely high, without immediate recognition and treatment with the antidote, dantrolene sodium.
About Malignant Hyperthermia Association of the United States
Established in 1981 when families who lost their children to Malignant Hyperthermia or were unable to find information about MH. Malignant Hyperthermia is a genetic disorder found in an estimated 1 out of every 2,000 people. Today MHAUS provides information and resources to medical andlay communities through conferences, educational materials, ID tags, 24-hour MH Hotline, MHAUS website, and with the help of MH Groups. The mission of the MHAUS is to promote optimum care and scientific understanding of MH and related disorders.