Satsuma Pharmaceuticals, Inc. announced that Phase 1 trial results detailing pharmacokinetics (PK), tolerability, and safety with its lead product candidate, STS101 (DHE (or dihydroergotamine) nasal powder for the acute treatment of migraine), have been published online in the official peer-reviewed journal of the American Headache Society, Headache, The Journal of Head and Face Pain. The publication reports results from a Phase 1, open-label, 2-part, active-controlled, 3-period crossover study sponsored by Satsuma and designed to investigate and compare the safety and PK of STS101, DHE liquid nasal spray (Migranal®), and intramuscular (IM) DHE injection in healthy subjects. Study authors concluded that STS101 showed a favorable tolerability profile and resulted in DHE plasma concentrations comparable to IM DHE and exceeding Migranal. Based on data from this study and the results from other clinical studies with DHE (including injected, liquid nasal spray, and orally inhaled DHE dosage forms), 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. Key findings described in the American Headache Society, Headache, The Journal of Head and Face Pain publication included the following: STS101 showed rapid absorption, achieving within 10 minutes the mean DHE plasma concentration threshold (1 ng/ml) that Satsuma estimates to be minimally necessary for efficacy based on prior clinical studies. Drug exposure was substantially greater than Migranal, comparable to IM DHE, and exceeded exposures previously reported for an orally inhaled DHE product candidate (MAP0004) by approximately 30 minutes post-dose and at all subsequent time points. MAP0004 previously demonstrated rapid onset of clinical efficacy and robust anti-migraine efficacy in a large, double-blind, placebo-controlled Phase 3 trial. STS101 PK variability was lower than Migranal, suggesting STS101 may have more predictable, reliable, and robust clinical performance. With STS101, maximum DHE plasma concentrations were sufficiently low so as to avoid nausea or vomiting, which are common side-effects with intravenous DHE. STS101 demonstrated a favorable tolerability profile and all treatment-related adverse events were mild, transient, and related to the nasal route of administration or known effects of DHE.