Satsuma Pharmaceuticals, Inc. (“Satsuma”, San Francisco, CA, USA) 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 therapeutics¹⁾ consisting of dihydroergotamine (“DHE”) and SNBL’s novel nasal delivery technology, STS101.

Satsuma announced that Phase 1 trial results detailing pharmacokinetics, tolerability, and safety with STS101 have been published online in the official peer-reviewed journal of the American Headache Society, Headache, The Journal of Head and Face Pain.

Study authors concluded that STS101 showed a favorable tolerability profile and resulted in DHE plasma concentrations comparable to intramuscular DHE and exceeding DHE liquid nasal spray (Migranal).  Based on data from this study and the results from other clinical studies with DHE, the authors posited that STS101 is anticipated to demonstrate rapid pain relief, improvement in functionality, and excellent 2-hour and sustained pain freedom rates.  

STS101 is currently being evaluated as an acute treatment for migraine in an ongoing Phase 3 efficacy trial (the EMERGE™ trial), for which Satsuma expects to report top-line data in the second half of this year.

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

The paper titled, A Phase 1, Randomized, Open-Label, Safety, Tolerability, and Comparative Bioavailability Study of Intranasal Dihydroergotamine Powder (STS101), Intramuscular Dihydroergotamine Mesylate, and Intranasal DHE Mesylate Spray in Healthy Adult Subjects, can be accessed at the following link:  https://headachejournal.onlinelibrary.wiley.com/doi/epdf/10.1111/head.13737

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.