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A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects

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Trial Profile

A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the PK, Bioavailability, Safety, and Tolerability of Single Doses of STS101, DHE IM Injection and DHE Nasal Spray in Healthy Adult Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 May 2023

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At a glance

  • Drugs Dihydroergotamine mesilate (Primary) ; Dihydroergotamine mesilate
  • Indications Migraine; Migraine with aura; Migraine without aura
  • Focus Pharmacokinetics; Registrational
  • Sponsors Satsuma Pharmaceuticals

    • Most Recent Events

    • 18 May 2023 According to a Satsuma Pharmaceuticals media release, 505 (b)(2) new drug application (NDA) for STS101 has been accepted for review by the FDA. NDA is supported by clinical trials results from pharmacokinetic and safety trial, ASCEND trial and SUMMIT trial. PDUFA date expected is January 2024.
    • 20 Dec 2022 According to a Satsuma Pharmaceuticals media release, the study supports a planned NDA filing in Q1 2023 and potential approval.
    • 12 Jun 2022 Results presented at the 64th Annual Scientific Meeting of the American Headache Society

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