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An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

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Trial Profile

An Open-Label, 12-Month Study to Evaluate the Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2025

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At a glance

  • Drugs Dihydroergotamine mesilate (Primary)
  • Indications Migraine; Migraine with aura; Migraine without aura
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCEND
  • Sponsors Satsuma Pharmaceuticals

Most Recent Events

  • 19 Jun 2025 According to a Satsuma Pharmaceuticals media release, data from this Phase 3 clinical study program were selected for presentation at the American Headache Society's (AHS) 67th Annual Scientific Meeting. The 2025 meeting will be held at the Minneapolis Convention Center Minneapolis, MN, from Thursday, June 19 to Sunday, June 22, 2025, including the option of participants attending virtually. Full abstracts are now available on the AHS website and will be published in the journal Headache.
  • 30 Apr 2025 According to a Satsuma Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved a 505(b)(2) New Drug Application (NDA) for Atzumi™(dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine with or without aura in adults.The FDA approval for Atzumi is based on two clinical studies (Phase 1 PK trial and ASCEND Phase 3 open-label, long-term safety trial).
  • 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.

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