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Phase 1, single-center, open-label study of a single dose of rimegepant in healthy lactating women

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Trial Profile

Phase 1, single-center, open-label study of a single dose of rimegepant in healthy lactating women

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 May 2022

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At a glance

  • Drugs Rimegepant (Primary)
  • Indications Migraine
  • Focus Pharmacokinetics

    • Most Recent Events

    • 26 Apr 2022 Results assessing kinetics of transfer of a single oral 75-mg dose of rimegepant into human milk presented at the 74th Annual Meeting of the American Academy of Neurology 2022
    • 14 Apr 2022 According to a Biohaven Pharmaceuticals media release, based on the data from this study, the U.S. Food and Drug Administration has approved a label amendment of the Nurtec ODT (rimegepant) Prescribing and Patient Information to include clinical lactation data in the Use in Specific Populations section as it relates to women who are breastfeeding.
    • 08 Apr 2022 New trial record

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