Phase 3, Multi-Center, Double-Blind, Randomized, 2-Arm, Parallel Study to Assess the Efficacy and Safety of Ryanodex (EGL-4104) as Adjuvant Treatment in Subjects With Exertional Heat Stroke (EHS)
Latest Information Update: 20 May 2021
At a glance
- Drugs Dantrolene (Primary)
- Indications Heat stroke
- Focus Registrational; Therapeutic Use
- Sponsors Eagle Pharmaceuticals
- 02 Mar 2020 According to an Eagle Pharmaceuticals media release, PDUFA date of July 8, 2020.
- 09 Jan 2020 According to an Eagle Pharmaceuticals media release, the Company has resubmitted its New Drug Application (NDA) for RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (EHS), in addition to body cooling, to the U.S. Food and Drug Administration.
- 11 Dec 2019 Status changed from recruiting to completed.