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)

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)

Completed
Phase of Trial: Phase II

Latest Information Update: 26 Jul 2017

At a glance

  • Drugs Dantrolene (Primary)
  • Indications Heat stroke
  • Focus Therapeutic Use
  • Sponsors Eagle Pharmaceuticals
  • Most Recent Events

    • 26 Jul 2017 According to an Eagle Pharmaceuticals media release, company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its 505(b)(2) New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS). In this letter,FDA has suggested to conduct an additional clinical trial for RYANODEX for Exertional Heat Stroke in this letter
    • 27 Mar 2017 According to an Eagle Pharmaceuticals media release, the 505(b)(2) New Drug Application (NDA) for Ryanodex for the treatment of exertional heat stroke (EHS) has been accepted for filing and granted a priority review designation by the U.S. Food and Drug Administration (FDA). Under the Prescription Drug User Fee Act (PDUFA), the FDA will aim to complete its review within six months of the NDA submission; the PDUFA date for the NDA has been set for July 23, 2017.
    • 23 Jan 2017 According to an Eagle Pharmaceuticals media release, company has completed the submission of its 505(b)(2) New Drug Application (NDA) for Ryanodex for the treatment of exertional heat stroke (EHS) to the U.S. Food and Drug Administration (FDA). Prescription Drug User Fee Act (PDUFA) date for a decision on the NDA would be July 2017; otherwise the Company anticipates approval of NDA later in 2017.
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