On multiple phase 3 trials, treatment with STS101 resulted in numerical differences on primary outcome measures of pain freedom and freedom from the most bothersome symptoms.
The FDA has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for its novel, investigational 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 STS101 NDA, 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, effective, and safe and well-tolerated DHE treatment that can address the significant unmet clinical needs of many people with migraine," John Kollins, president and chief executive officer, Satsuma, said in a statement.1
The NDA was backed by findings from a phase 1 comparative pharmacokinetic and safety trial (NCT03874832) and the phase 3, long-term ASCEND trail (NCT04406649). Based on previous communications with the FDA, results from the phase 3 SUMMIT trial (NCT04406649) may be included in the NDA, although they are not required for approval.
STS101 is designed to provide significant benefits vs existing acute treatments for migraine, including the combination of quick and convenient self-administration and other clinical advantages that current DHE liquid nasal spray products and injectable dosage forms lack. The dry powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations.
Findings from SUMMIT, announced in December 2022, showed numerical, but not statistically significant, differences vs placebo on the co-primary end points of freedom from pain and freedom from the most bothersome symptom (MBS) 2 hours post-dose. The therapy continued to demonstrate robust and sustained effects (P <.001) on the key study end points 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 a multicenter, open-label, safety trial that included 480 individuals, 466 of whom self-administered at least 1 dose of STS101Mk1 or STSMk2 study medication. Satsuma completed a transition of study medication from STS101Mk1 to STSMk2 in the first half of 2021. In the study, no clinically relevant nasal safety or tolerability findings, cinically relevant systemic safety findings, or unexpected treatment-related serious AEs, were reported among patients on STS101Mk2 (n = 344). A low proportion of individuals (4.1%) cited an AE as the reason for discontinuing participation in the trial.3
Among 172 trial participants exclusively treated with STS101Mk2, freedom from pain by 2 hours post-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 more than 81% of treated attacks, individuals did not report utilizing an allowed second dose of STS101Mk2 within 48 hours of administering the first dose.