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EMERGE: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

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Trial Profile

EMERGE: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Nov 2024

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At a glance

  • Drugs Dihydroergotamine mesilate (Primary)
  • Indications Migraine
  • Focus Registrational; Therapeutic Use
  • Acronyms EMERGE
  • Sponsors Satsuma Pharmaceuticals

Most Recent Events

  • 30 Oct 2024 According to a Satsuma Pharmaceuticals media release, company announced the resubmission of the new drug application (NDA) for the investigational product STS101 for the acute treatment of migraine with or without aura. FDA issued a complete response letter (CRL) in January 2024 for the original NDA submitted in March 2023. After a Type A meeting to discuss the contents of the CRL, Satsuma and SNBL believe the NDA resubmission addresses all findings in the CRL.
  • 16 Apr 2023 According to a Satsuma Pharmaceuticals media release, the company has submitted a New Drug Application (NDA) to the USA Food and Drug Administration (FDA) in March 2023 for STS101.
  • 11 May 2021 According to a Satsuma Pharmaceuticals media release, the company expects to file STS101 NDA by the end of 2022.

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