Satsuma Pharmaceuticals, Inc. (“Satsuma”, San Francisco, CA, USA) (Nasdaq: STSA) was established in June 2016 with the purpose of globally expanding the Translational Research business of Shin Nippon Biomedical Laboratories, Ltd. (“SNBL”) by developing migraine therapeutics consisting of dihydroergotamine (“DHE”) and SNBL’s novel nasal delivery technology, STS101¹⁾.

Today, Satsuma announced positive safety, tolerability and efficacy results from its recent analysis of the Company’s ongoing STS101 ASCEND Phase 3 open-label, long-term safety trial. 

Satsuma expects the results from this analysis, in addition to Phase 1 trial data and results from its ongoing SUMMIT Phase 3 efficacy trial, which the Company expects to announce in the fourth quarter of 2022, to support submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) planned for the first quarter of 2023.

For more information, please visit Satsuma’s press release.

1) STS101

There are currently an estimated 39 million people in the U.S. suffering from migraine headaches, and the market for migraine therapeutics is reported to have reached $16 billion in 2017 in the US alone. A large number of patients are relatively young, between 20 and 40 years old, and there is an existing need for quick relief of potentially-disabling headaches. DHE is effective for non-responders of triptans, which are currently first-in-line therapies; however, the current liquid nasal spray is slow to absorb, taking at least 30 minutes to take effect, and the product is regarded to be unreliable due to its variability in absorption and the relatively low blood concentrations it achieves. The STS101, Nasal DHE product using SNBL's nasal delivery technology, enables fast and adequate absorption and is expected to meet the needs of patients.