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Thursday, November 24, 2022

Satsuma: Favorable efficacy results in Phase 3 migraine treatment trial

 Favorable efficacy results from the 172 subjects such as freedom from pain (Pain Free) by 2 hours post-treatment was achieved in 34.2% of all treated attacks, and freedom from most- bothersome-symptoms (MBS Free) from among photophobia, phonophobia and nausea by 2 hours post-treatment was achieved in 53.4% of all treated attacks. The SUMMIT study, a randomized, double-blind, placebo-controlled study for STS101, was designed to assess the efficacy of a single dose of STS101_5.2 mg (incorporated the second-generation nasal delivery device) in the acute treatment of migraine in more than 1,400 subjects. In accordance with the U.S. Food and Drug Administration's (FDA) Guidance for the Development of Drugs for the Treatment of Acute Migraine, the co-primary endpoints for STS101_5.2 mg, Pain Free and MBS Free at 2 hours post-dose, were statistically evaluated in comparison with placebo.

https://www.marketscreener.com/quote/stock/SATSUMA-PHARMACEUTICALS-65220683/news/Satsuma-Pharmaceuticals-Inc-Announces-the-Results-of-Phase-3-Clinical-Studies-for-STS101-42402039/

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