Eagle Pharmaceuticals Announces FDA Acceptance Of NDA For Ryanodex In Malignant Hyperthermia
By Cyndi Root
Eagle Pharmaceuticals announced in a press release that the Food and Drug Administration has accepted the company's New Drug Application (NDA). The FDA granted priority review for Ryanodex (dantrolene) and issued the PDUFA date for July 22, 2014, the final day for the FDA to respond to the application. In January of this year, Eagle filed the application for malignant hyperthermia and in February, the federal agency tentatively accepted the trade name Ryanodex.
Scott Tarriff, CEO of Eagle Pharmaceuticals said, "Each vial of Ryanodex is reconstituted in less than one minute by the anesthesiologist in contrast to the need to mix and administer approximately 12 vials of currently marketed products. Eagles' Ryanodex formulation has reduced the required volume by more than 95% for an equivalent dose."
Malignant Hyperthermia
Malignant hyperthermia (MH) is an inherited disorder triggered by anesthetics or the muscle relaxant succinylcholine. When the patient accidentally inhales the triggering drugs, cell calcium increases, and metabolism accelerates in the skeletal muscles. Patients can move very quickly into a hyper-metabolic episode, which can be fatal. Symptoms include high blood pressure, high body temperature, tachycardia, and raised CO2 levels. Dantrolene can reverse the condition.
Ryanodex
Ryanodex is the brand name for dantrolene, the only medication available for MH. In the 1960s, deaths decreased from 80 percent to less than 10 percent with the administration of the drug. Dantrolene works by disrupting the excitation and contraction of muscle. Through direct or indirect molecular action, the drug decreases calcium concentration, slowing metabolism. Dantrolene is also used for epileptic conditions and Ecstasy overdoses. Dantrolene is on hand for surgical procedures, but due to the emergency nature of MH, formulating it quickly is often an issue.
The Eagle product, Ryanodex, constitutes in one minute, saving precious time that the patient does not have. Competing products can take up to 20 minutes to mix. It mixes with 5 mL of sterile water, compared to 60 mL in competitor products. The actual amount of fluid administered to the patient is 5 mL, limiting physiological consequences. Eagle Pharmaceuticals holds three U.S. patents for the drug and the FDA has granted Orphan Drug status and exclusive marketing rights when approved.