FDA Accepts NDA for DHE STS101 Nasal Powder Product for Acute Migraine

The FDA accepted Satsuma Pharmaceuticals 505(b)(2) New Drug Application (NDA) for its investigational new dihydroergotamine (DHE) nasal powder product, STS101, for the acute treatment of migraine. The agency is expected to make a decision on the therapy by January 2024.¹

“We are proud to announce the FDA acceptance for review of our NDA STS101, as it represents an important milestone for our company and an important step toward achieving our goal of making STS101 available as an easy-to-use tool, effective and safe and well-tolerated DHE treatment that can address the significant unmet clinical needs of many people with migraine,” said John Kollins, president and chief executive officer of Satsuma, in a statement.¹

The NDA was supported by results from a phase 1 (NCT03874832) and phase 3, long-term ASCEND pathway (NCT04406649) comparative pharmacokinetic and safety study. Based on previous communications with the FDA, results from the Phase 3 SUMMIT study (NCT04406649) may be included in the NDA, although they are not required for approval.

STS101 is designed to provide significant advantages over existing acute migraine treatments, including the combination of rapid and convenient self-administration and other clinical advantages that current DHE liquid nasal spray products and injectable dosage forms lack. DHE dry powder formulation demonstrated rapid absorption, rapid achievement of high plasma concentrations of DHE.

The SUMMIT results, announced in December 2022, showed numerical, but not statistically significant, differences from placebo on the co-primary endpoints of freedom from pain and freedom from most bothersome symptom (MBS) 2 hours after dosing. The therapy has continued to demonstrate robust and sustained effects (P <.001) on key study endpoints at all dose timepoints after 2 hours (3, 4, 6, 12, 24 and 48 hours). STS101 showed a favorable safety and tolerability profile, with nasal discomfort, reported in 8.3% of treated individuals, as the most common treatment-emergent adverse events.²

ASCEND was an open-label, multicenter safety study including 480 individuals, 466 of whom self-administered at least 1 dose of study drug STS101Mk1 or STSMk2. Satsuma completed the study drug transition from STS101Mk1 to STSMk2 in the first half of 2021. In the study, there were no clinically relevant nasal safety or tolerability findings, clinically relevant systemic safety findings, or unexpected serious adverse events reported treatment-related, among patients in STS101Mk2 (n = 344). A low percentage of individuals (4.1%) cited an adverse event as a reason for discontinuing study participation.³

Among 172 study participants treated exclusively with STS101Mk2, pain freedom within 2 hours after treatment was achieved in 34.2% of all treated attacks. Freedom from MBS at this time was achieved in 53.4% ​​of all treated attacks. In over 81% of treated attacks, people did not report using a second permitted dose of STS101Mk2 within 48 hours of receiving the first dose.

REFERENCES
1. Satsuma Pharmaceuticals announces FDA acceptance of NDA 505(b)(2) for STS101, an investigational new dihydroergotamine (DHE) nasal powder for the acute treatment of migraine. Press release. Satsuma Pharmaceuticals. May 18, 2023. Accessed May 26, 2023. https://www.globenewswire.com/news-release/2023/05/18/2672216/0/en/Satsuma-Pharmaceuticals-Annonces-FDA-Acceptance-of-505 -b -2-NDA-for-STS101-a-new-and-investigative-dihydroergotamine-DHE-nasal-powder-product-for-the-acute-treatment-of-migraine.html
2. Satsuma Pharmaceuticals provides STS101 development program and business update. Press release. Satsuma Pharmaceuticals. December 20, 2022. https://investors.satsumarx.com/2022-12-20-Satsuma-Pharmaceuticals-Provides-STS101-Development-Program-and-Corporate-Update

3. Satsuma Pharmaceuticals announces positive results from the ongoing Phase 3 open-label STS101 ASCEND long-term safety study. Press release. Sep 20, 2022. Accessed May 26, 2023. https://www.biospace.com/article/releases/satsuma-pharmaceuticals-announces-positive-results-from-the-ongoing-sts101-ascend-phase-3-open-label -proof-of-long-term-safety/