Dihydroergotamine Nasal Powder Under Review for Acute Treatment of Migraine

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for STS101 (dihydroergotamine [DHE] nasal powder) for the acute treatment of migraine.

STS101 is an investigational DHE nasal powder product that is administered via a proprietary nasal delivery device. The Company believes that the dry powder DHE formulation will provide fast absorption and robust efficacy compared with existing DHE products. Dihydroergotamine is currently available in an injectable formulation and as a nasal spray.

The NDA is supported by data from a long-term, open-label, phase 3 trial (ClinicalTrials.gov Identifier: NCT04406649), which included 446 adults with at least a 1 year history of migraine with or without aura. A total of more than 10,500 doses of STS101 were administered to treat more than 9000 migraine attacks for up to 18 months. Treatment-emergent adverse events reported during the trial included nasal discomfort and dysgeusia, which were typically mild and transient.

The application also included data from the double-blind, placebo-controlled phase 3 SUMMIT trial (ClinicalTrials.gov Identifier: NCT04940390). While the primary outcome results were not considered statistically significant, treatment with STS101 demonstrated robust and sustained effects on freedom from pain and freedom from most bothersome symptom at all post-dose timepoints after 2 hours (3, 4, 6, 12, 24 and 48 hours).

A regulatory decision is expected in January 2024.