Eagle Pharma (EGRX) Commences Rolling Submission of Ryanodex NDA as EHS Treatment

November 11, 2016 6:57 AM EST

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Eagle Pharmaceuticals (Nasdaq: EGRX) announced that the Company has initiated the rolling submission of its New Drug Application (NDA) and filed the first part of the application to the U.S. Food and Drug Administration (FDA) for Ryanodex (dantrolene sodium) for injectable suspension for the treatment of exertional heat stroke (EHS), an investigational new indication for the product. The rolling submission allows completed portions of an NDA to be submitted, which may then be reviewed by the FDA on an ongoing basis. The FDA had previously granted Fast Track Designation for the development of Ryanodex for the treatment of EHS, which allows for submission of parts of an NDA application (rolling review).

The first part of this rolling submission includes the human safety and efficacy data from the clinical study in EHS patients conducted in a ‘real-world’ clinical setting, at the Emergency Department of four hospitals during the 2015 Hajj Islamic Pilgrimage, in the Kingdom of Saudi Arabia.

Eagle is currently conducting animal studies to further support the safety and efficacy of Ryanodex for the treatment of EHS. The Prescription Drug User Fee Act (PDUFA) review clock will begin once the complete NDA has been submitted.

The FDA provides designation of a drug as a Fast Track product if it is intended for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition. This provision is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved drug product can reach the market expeditiously.

Ryanodex is protected by two filed and five issued patents.

“With no drug indicated for the treatment of EHS, initiation of the NDA submission process marks an important step forward in our efforts to make a meaningful difference in the lives of people affected by this potentially life-threatening condition. We look forward to working closely with the FDA towards the goal of making Ryanodex available to these patients as soon as possible,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Results of the clinical study demonstrated that the use of Ryanodex in addition to the current standard of care (“SOC”) showed substantial evidence of increased effectiveness in treating EHS than SOC alone, and that the safety profile of Ryanodex in EHS patients was consistent with the known and well characterized safety profile of Ryanodex for the currently approved indications. The current SOC for the treatment of EHS is limited to body cooling by physical methods (e.g., water immersion, evaporative cooling) and supportive measures (e.g., IV fluids, respiratory support, cardiac monitoring).

Additional information regarding the clinical study in EHS patients and its outcomes can be found in Eagle’s press release dated December 17, 2015.

About Exertional Heat Stroke

Exertional Heat Stroke (“EHS”) is a rare, sudden and unpredictable disorder that constitutes a medical emergency which may result in severe multi-organ dysfunction and death. EHS is more commonly seen in young people undergoing exertional physical activity in a hot weather environment, and is one of the leading causes of death in young athletes. EHS cases are also observed in construction workers, firefighters, military personnel, and farmers. There is no currently approved drug product for the treatment of EHS.



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