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Pivotal bioavailability study of rizatriptan oral thin-film preparation (RHB 103) in Europe

Trial Profile

Pivotal bioavailability study of rizatriptan oral thin-film preparation (RHB 103) in Europe

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 22 Oct 2019

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At a glance

  • Drugs Rizatriptan (Primary) ; Rizatriptan
  • Indications Migraine
  • Focus Pharmacokinetics; Registrational
  • Sponsors IntelGenx Corp.; RedHill Biopharma
  • Most Recent Events

    • 22 Oct 2019 According to an IntelGenx Corp media release, the New Drug Application(NDA) for RIZAPORT VersaFilm for the treatment of acute migraines has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date for completion of the review of March 26, 2020.
    • 26 Sep 2019 According to an IntelGenx Corp media release, the company announced that it has resubmitted its 505(b)(2) New Drug Application(NDA) for RIZAPORT VersaFilm for the treatment of acute migraines to the U.S. Food and Drug Administration (FDA). This resubmitted NDA is subject to the FDA's acceptance review, the results of which are expected within 30 days.
    • 02 Apr 2019 According to an IntelGenx Corp media release, the company has received a Complete Response Letter (CRL) from the U.S. FDA regarding its resubmitted 505(b)(2) New Drug Application (NDA) for RIZAPORT VersaFilm for the treatment of acute migraines. The issues cited in the CRL relate to the Chemistry, Manufacturing and Controls section of the application. The Agency requested additional information, but no new bioequivalence study. RIZAPORT NDA resubmission anticipated the before the end of Q3-2019.
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