Satsuma Pharmaceuticals, Inc., and its parent company, Shin Nippon Biomedical Laboratories, Ltd. (SNBL), have announced that the U.S. Food and Drug Administration (FDA) has accepted for review their resubmitted New Drug Application (NDA) for STS101, an investigational dihydroergotamine (DHE) nasal powder, intended for the acute treatment of migraine with or without aura. This action follows a Complete Response Letter (CRL) issued by the FDA in January 2024, and the Prescription Drug User Fee Act (PDUFA) date is set for April 30, 2025.
Addressing Unmet Needs in Migraine Treatment
Migraine is a debilitating condition affecting approximately 40 million people in the United States, with a significant prevalence among women in their 20s to 40s. The U.S. market for acute migraine medications is estimated to be over $1 billion, highlighting the substantial need for effective and convenient treatments. STS101 aims to address this need with its unique nasal powder formulation of DHE, designed for rapid self-administration and quick relief.
STS101: A Novel Nasal Powder Formulation
STS101 is a proprietary nasal powder formulation of dihydroergotamine mesylate (DHE), a well-established anti-migraine drug. Administered via Satsuma's proprietary nasal delivery device, STS101 is designed to provide patients with a combination of quick and convenient self-administration. The nasal powder DHE formulation has demonstrated fast absorption, rapid achievement of high DHE plasma concentrations, sustained DHE plasma levels over time, and low dose-to-dose variability.
Clinical Trial Data and Safety Profile
The resubmission is supported by data from a Phase 1 comparative pharmacokinetic and safety trial (NCT03874832) and the Phase 3 ASCEND trial (NCT04406649). The FDA's prior CRL indicated no concerns related to the clinical trial results, including the safety of STS101, and did not request additional clinical trials. The agency's comments primarily related to formulation (Chemistry, Manufacturing, and Control - CMC), which Satsuma and SNBL believe have been adequately addressed in the resubmission.
The ASCEND trial, a multicenter, open-label safety study, included 480 participants, with 466 self-administering at least one dose of STS101Mk1 or STS101. The study reported no clinically relevant nasal safety or tolerability findings, systemic safety findings, or unexpected treatment-related serious adverse events (AEs) among patients on STS101 (n = 344). Only 4.1% of individuals cited an AE as the reason for discontinuing participation in the trial.
Implications for Migraine Patients
The FDA's acceptance of the NDA resubmission for STS101 represents a significant step forward in providing a novel, non-oral treatment option for migraine patients. If approved, STS101 could offer a valuable alternative for those who have experienced inadequate relief with existing therapies or who are unable to achieve rapid relief with oral routes of administration. The PDUFA date of April 30, 2025, is highly anticipated by both the companies and the migraine community.
