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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Apr 2023

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At a glance

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

    • 17 Apr 2023 According to an IntelGenx Corp media release, the U.S. Food and Drug Administration ("FDA") has approved the RIZAFILM VersaFilm 505(b)(2) new drug application (NDA) for the treatment of acute migraine.
    • 22 Nov 2022 According to an IntelGenx Corp media release, the USA Food and Drug Administration (FDA) has accepted for review its Class 2 response to the 2020 Complete Response Letter for its 505(b)(2) New Drug Application (NDA) for RIZAFILM. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the review of the RIZAFILM NDA.
    • 18 Oct 2022 According to an IntelGenx Corp media release, the company has responded to the Complete Response Letter (CRL) for its 505(b)(2) New Drug Application (NDA) for RIZAPORT VersaFilm received from the U.S. FDA in March 2020. Based on the feedback from Type A meeting, the company conducted additional product testing and believe that this response provides all of the additional Chemistry, Manufacturing and Controls information that the FDA required.
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