With operations in South San Francisco, CA and Research Triangle Park, NC, Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing STS101 (dihydroergotamine mesylate (DHE) nasal powder) as an important and differentiated therapeutic option for the acute treatment of migraine.
First marketed in the U.S. in 1946 in an injectable solution dosage form, DHE has long been viewed by many headache specialists as a safe and effective treatment for migraine, particularly for many people with migraine whose attacks are nonresponsive to or difficult to effectively treat with other treatments, such as triptans. However, broad use of DHE has been limited by invasive and burdensome administration and/or sub-optimal clinical performance of available injectable and liquid nasal spray products.
STS101 is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug DHE, with a pharmacokinetic profile designed to provide reliable, robust and consistent clinical performance in the acute treatment of migraine. In developing STS101, Satsuma has applied proprietary nasal drug delivery device, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be quickly and easily self-administered in matter of seconds.
The Company believes STS101, if approved, could be an attractive acute treatment option for many people with migraine and may enable a larger number of people with migraine to realize the long-recognized therapeutic benefits of DHE therapy. STS101 has undergone extensive pre-clinical development and optimization, completed a Phase 1 clinical trial in late 2018, a randomized, double-blind, placebo-controlled Phase 3 efficacy trial (the EMERGE study) in 2020, and is currently being evaluated for long-term safety in in the ongoing open-label ASCEND trial.
For further information about the ASCEND trial, please see identifier NCT04406649 at clinicaltrials.gov.
people in the U.S. suffer from migraine
leading cause of disability worldwide in terms of years lost to disability
lost workdays annually in the U.S.
annually in estimated healthcare & lost productivity costs in U.S.