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⁾ using SNBL’s novel nasal delivery technology. Satsuma subsequently obtained funding from third party venture capital firms and conducted a Phase I clinical trial for its nasal dihydroergotamine formulation (“DHE”), STS101.

Satsuma has completed the Phase I clinical trial with STS101 showing consistently high and rapid absorption with excellent tolerability. Satsuma successfully completed a meeting with the FDA establishing key elements for a Phase III program to support a New Drug Application (NDA). Satsuma will proceed with the Phase III clinical trial in the third quarter of 2019 (Jul – Sep).

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.