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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)

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: 12 Nov 2019

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At a glance

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

    • 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).
    • 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.
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