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BHV3000-302 : Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

Trial Profile

BHV3000-302 : Phase 3: Double-Blind, Randomized, Placebo-Controlled, Safety and Efficacy Trial of BHV-3000 (Rimegepant) for the Acute Treatment of Migraine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Nov 2019

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At a glance

  • Drugs Rimegepant (Primary)
  • Indications Migraine
  • Focus Registrational; Therapeutic Use
  • Sponsors Biohaven Pharmaceutical; Biohaven Pharmaceutical Holding Company
  • Most Recent Events

    • 19 Nov 2019 Results published in the Annals of Internal Medicine
    • 01 Nov 2019 According to a Biohaven Pharmaceutical media release, United States Food and Drug Administration (FDA) has accepted the the new drug applications (NDAs) for rimegepant and expected Prescription Drug User Fee Act (PDUFA) date of the first quarter of 2020 for the Zydis orally dissolving tablet (ODT) formulation.
    • 11 Jul 2019 Results assessing efficacy and safety of rimegepant in acute migraine treatment published in the New England Journal of Medicine
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