Eagle Pharmaceuticals has entered into an agreement with the National Institutes of Health (“NIH”)/National Institute on Drug Abuse (“NIDA”) to explore the use of Ryanodex® in the treatment of hyperthermia related to MDMA (“Ecstasy”) and Methamphetamine intoxication, which is a life-threatening condition mostly affecting adolescents and young adults. The preclinical studies will be conducted by NIDA beginning in the summer of 2016 utilizing a well-characterized animal model. Initial results of the focused studies are anticipated in late 2016 or early 2017.
“We are very pleased to be working alongside the NIH to explore the potential of Ryanodex to reduce elevated body and brain temperature resulting from the use of Ecstasy and Methamphetamine. Results of our recently completed clinical study of Ryanodex for Exertional Heat Stroke indicated that patients receiving Ryanodex in addition to standard of care (SOC) -- which is currently limited to body cooling and supportive measures -- experienced an incremental therapeutic benefit over patients receiving SOC only,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
“We believe that Ryanodex has the potential to provide benefit to patients experiencing pathological thermal dysregulation associated with the use of Ecstasy and Methamphetamine,” stated Adrian Hepner, Executive Vice President and Chief Medical Officer. “We anticipate that having positive outcomes from our preclinical studies would enable us to meet with FDA and potentially lead to a rapid transition into pivotal clinical trials. Clinical studies in emergency settings are of relatively short duration due to the nature of the disorder and the known distribution of cases of ecstasy and methamphetamine intoxication, commonly associated with large holiday celebrations.”
“The development of Ryanodex for body and brain hyperthermia associated with intoxication from illicit psychostimulant drugs in a preclinical model in collaboration with NIDA experts, will be an important step forward in addressing the serious consequences of this condition,” added Hepner.
Brain hyperthermia is one of the leading causes of severe morbidity and death in MDMA (“Ecstasy”) and Methamphetamine intoxication. In 2011, the last year for which data is available, 125,000 emergency room visits were related to Ecstasy and Methamphetamine use. Methamphetamines are the fourth most reported illicit drug in emergency room visits following cocaine, marijuana, and heroin. And, according to the Drug Abuse Warning Network (“DAWN”), the number of emergency room visits involving Ecstasy among patients younger than 21 increased 128 percent between 2005 and 2011.