Satsuma Pharmaceuticals, Inc. (“Satsuma”, San Francisco, CA, USA) was established in June 2016 with the purpose to globally expand the Translational Research business of Shin Nippon Biomedical Laboratories, Ltd. (“SNBL”) by developing migraine therapeutics¹⁾ consisting of dihydroergotamine (“DHE”) and SNBL’s novel nasal delivery technology, STS101.

On August 22, 2019, Satsuma announced the completion of administration to the first patient in a Phase 3 EMERGE efficacy trial of STS101 for acute treatment of migraine. The Phase 3 EMERGE efficacy trial of STS101 is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in approximately 1,140 migraine patients being conducted in the United States. The EMERGE study was designed in accordance with FDA recommendations outlined in the FDA Guidance Migraine: Developing Drugs for Acute Treatment, February 2018. Satsuma expects to report top-line data from the EMERGE trial in the second half of 2020.

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

1) About migraine

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 Nasal DHE product using SNBL's nasal delivery technology enables fast and adequate absorption and is expected to meet the needs of patients.