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　randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for acute treatment of migraine.

The SUMMIT Phase 3 efficacy trial of STS101 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in approximately 1,400 subjects with migraine that is being conducted in the United States. The SUMMIT study was designed in accordance with FDA recommendations. Eligible participants are randomized (1:1) to receive either STS101 5.2 mg or matching placebo and instructed to treat their next migraine attack of at least moderate pain severity with the allocated blinded study medication. The co-primary endpoints of the trial, to be assessed at two hours after STS101 administration, are freedom from pain and freedom from the most bothersome symptom (from among photophobia, phonophobia or nausea).

Satsuma expects to report top-line data from the SUMMIT trial in the second half of 2022.

For more information on this announcement, please visit the Satsuma Press Release, here.

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.