eClinical Technology and Industy News

Satsuma Pharmaceuticals Announces Completion of Enrollment in SUMMIT Pivotal Phase 3 Efficacy Trial of STS101 for the Acute Treatment of Migraine

– More than 1,400 subjects randomized –
– Satsuma expects to announce topline SUMMIT trial results in Q4 2022 –

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif., Aug. 02, 2022 (GLOBE NEWSWIRE) — Satsuma Pharmaceuticals, Inc. (Nasdaq: STSA), a clinical-stage biopharmaceutical company developing STS101 (dihydroergotamine (DHE) nasal powder), a novel investigational therapeutic product candidate for the acute treatment of migraine, today announced completion of subject enrollment in the Company’s ongoing STS101 SUMMIT pivotal Phase 3 efficacy trial, with more than 1,400 subjects randomized. Satsuma expects to announce topline results from the SUMMIT trial in the fourth quarter of 2022.  

“We are pleased to report completion of subject enrollment in the STS101 SUMMIT Phase 3 efficacy trial, the largest-ever randomized and controlled trial of a DHE product,” stated John Kollins, Satsuma’s President and Chief Executive Officer. “This marks an important milestone in our STS101 development program. We look forward to reporting SUMMIT trial topline results in the fourth quarter of 2022, and, in the interim, to reporting further STS101 development program progress and clinical data, including topline results from our ongoing STS101 ASCEND Phase 3, open-label, long-term safety trial.”

STS101 SUMMIT Pivotal Phase 3 Efficacy Trial
The STS101 SUMMIT pivotal Phase 3 efficacy trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in more than 1,400 subjects with migraine that is being conducted in the United States. The trial is designed in accordance with recommendations contained in the U.S. Food and Drug Administration’s (FDA) current guidance document for industry (Migraine Developing Drugs for Acute Treatment, February 2018) and the International Headache Society’s (IHS) published guidelines for controlled trials of acute treatment of migraine attacks in adults.1 The SUMMIT trial, the largest-ever randomized and controlled trial of a DHE product, provides a basis for STS101 to become the first and only DHE product to demonstrate efficacy in a randomized and controlled trial on co-primary endpoints (freedom from pain and freedom from most bothersome symptom at two hours post-treatment) currently recommended by the FDA and IHS. Based on Satsuma’s communications with the FDA, including a Type B, clinical pre-NDA videoconference meeting held in May 2022, the Company believes the SUMMIT trial, if successful, will support inclusion of differentiating efficacy claims in the STS101 prescribing information, presuming STS101 is approved for marketing.

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