FDA Approves Ryanodex, New MH Drug



The FDA has approved Ryanodex (Eagle Pharmaceuticals) for the treatment of malignant hyperthermia, marking the first major development for the life-threatening complication of anesthesia in more than 30 years, according to the manufacturer.

The drug, an injectable suspension of dantrolene sodium, will be available in 250 mg single-use vials containing the active ingredient in a lyophilized powder. According to Eagle Pharmaceuticals, Ryanodex can be prepared and administered in less than one minute, compared with 15 to 20 minutes for conventional dantrolene.

“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, president of the Malignant Hyperthermia Association of the United States, in a statement. “The ability for health care 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 will be available to order from drug wholesalers in August, the company said.

For more information, visit ryanodex.com.

Picture courtesy of www.trademarkia.com





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