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

Completed
Phase of Trial: Phase I

Latest Information Update: 13 Apr 2017

At a glance

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

    • 13 Apr 2017 According to a RedHill Biopharma media release, RedHill and IntelGenx expect to re-submit the RIZAPORT 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the third quarter of 2017.
    • 13 Apr 2017 According to a RedHill Biopharma media release, the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines. The national marketing authorization was granted in Luxembourg on the basis of the European Decentralized Procedure (DCP), in which Luxembourg served as the Concerned Member State.
    • 10 Sep 2015 According to a RedHill Biopharma media release, the German Federal Institute for Drugs and Medical Devices (BfArM) has confirmed the positive outcome of the European Decentralized Procedure and informed RedHill and IntelGenx that the European MAA of RIZAPORT (rizatriptan, RHB-103) for the treatment of acute migraines is approvable.
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