Interim Analysis of STS101 Nasal Safety Data From the Phase 3 Open-Label ASCEND Migraine Study
Egilius Spierings1, Detlef Albrecht2, Alan Rapoport3
1MEDVADIS RESEARCH, 2Satsuma, 3David Geffen School of Medicine at UCLA
Objective:
To assess the long-term nasal safety and tolerability of STS101 in the acute treatment of migraine.
Background:
STS101 (dihydroergotamine nasal powder) is a novel investigational product with rapid and easy nasal delivery. The ASCEND study assesses the safety and tolerability of STS101 5.2 mg in the acute treatment of migraine with/without aura over 12 months.
Design/Methods:
ASCEND (NCT04406649) is a multi-center, multiple-dose, open-label study in adults (18-65 years) with migraine. Participants self-administered STS101 for ≤2 doses/24 hours and ≤12 doses/month for acute treatment of migraines for 12 months. This interim analysis included participants exclusively using the STS101 incorporating the second-generation nasal delivery device planned for commercialization. Nasal safety assessments included nasal treatment-emergent adverse events (TEAEs), subjective assessments of nasal irritation, and a smell test (SIT). Objective nasal assessments were done by trained study personnel on a 4-point severity scale to document nasal erythema, edema, rhinorrhea, bleeding, and nasal mucosa ulcerations.
Results:
This population included 344 subjects who treated 5,571 attacks with 6,918 doses of STS101 and was 40.4±10.9 years old (mean±SD), 85.8% female, and 87.5% Caucasian. Overall, 97 subjects (28.2%) reported nasal/local TEAEs; 8 of 344 subjects (2.9%) discontinued the study due to nasal/local TEAEs including nasal burning/discomfort (5), nasal bleeding (1), rhinitis (1), and throat tightness (1). Most frequently reported nasal/local related TEAEs were nasal discomfort (38 [11.0%] subjects; 338 [6.1%] attacks), dysgeusia (26 [7.6%]; 154 [2.8%]), and nasal congestion (14 [4.4%]; 198 [3.6%]). At 12 months, 99.5%, 95.4%, 93.5%, and 94.4% of subjects had no nasal bleeding/ulceration, edema, erythema, or rhinorrhea, respectively. No clinically relevant findings were seen from nasal examinations, subjective nasal irritation assessments, or smell tests.
Conclusions:
Nasal safety data from 5,571 treated attacks demonstrate the safety and tolerability of STS101 for the acute treatment of migraine.