SNBL’s nasal drug delivery platform is a proprietary system consisting of powder carrier technology and delivery device technology.
3D Nasal Cast Model
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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).
Satsuma today announced an update to the development plan for STS101 (DHE nasal powder). The updated development plan includes a new Phase 3 efficacy trial, which the Company anticipates initiating in mid-2021, with topline results expected in the second half of 2022. Satsuma anticipates filing its NDA in the fourth quarter of 2022.
Satsuma also announced today that it has entered into a securities purchase agreement with existing and new investors for an $80 million private placement financing. The Company believes that net proceeds from the private placement financing, together with its existing cash, cash equivalents and short-term investments of $68.2 million as of December 31, 2020, will be sufficient to fund company operations into the second half of 2023.
For more information, please visit Satsuma Press Release 1, 2
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.