Company Description
Satsuma Pharmaceuticals is a biopharmaceutical company dedicated to developing best-in-class products to address the unmet needs of migraine sufferers. As a wholly-owned subsidiary of Shin Nippon Biomedical Laboratories, Ltd. (SNBL), Satsuma is currently in the late stages of seeking regulatory approval from the U.S. Food and Drug Administration for its novel investigational therapeutic product, STS101.
STS101 is a unique nasal powder formulation of the well-established anti-migraine drug, dihydroergotamine mesylate (DHE). Administered via Satsuma’s proprietary nasal delivery device, STS101 aims to offer several benefits over existing acute migraine treatments. These include quick and convenient self-administration and several clinical advantages that current DHE liquid nasal spray products and injectable forms do not offer. The dry powder formulation of STS101 has shown to achieve rapid absorption and high DHE plasma concentrations, necessary for robust efficacy, and sustained plasma levels over time with low dose-to-dose variability.
DHE has long been recommended as a first-line treatment option for acute migraine in published treatment guidelines. However, the invasive and burdensome administration methods and sub-optimal clinical performance of existing DHE liquid nasal sprays and injectables have limited its widespread use. STS101, with its easy-to-carry and easy-to-use form, is designed to overcome these limitations, offering an improved therapeutic solution for acutely treating migraines.
STS101 has recently showcased its sustained efficacy in the Phase-3 Double-Blind, Randomized, Placebo-Controlled SUMMIT Study. The results were presented in an oral presentation, highlighting the potential of STS101 to become a significant advancement in migraine treatment.
Please note that forward-looking statements about the company’s future performance and expectations are subject to risks and uncertainties.
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