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Phase 2, Single-Site, Open-Label, 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)

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Trial Profile

Phase 2, Single-Site, Open-Label, 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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Jul 2021

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At a glance

  • Drugs Dantrolene (Primary)
  • Indications Heat stroke
  • Focus Registrational; Therapeutic Use
  • Sponsors Eagle Pharmaceuticals

Most Recent Events

  • 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
  • 12 Nov 2019 According to an Eagle Pharmaceuticals media release, the company enrolled 10 additional patients in the trial (293560) at the 2019 Hajj pilgrimage held from 9th-14th Aug in Saudi Arabia, bringing the total number of patients recruited in 2015, 2018 and 2019 to 41.The company has submitted a plan to FDA that proposes reviewing the data collectively for all 41 patients. If FDA agrees with this plan,the company plans to resubmit the New Drug Application of RYANODEX for exertional heat stroke (EHS).

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