A Long-term, Open-label Safety and Tolerability Study of Precision Olfactory Delivery of DHE in Acute Migraine Treatment (STOP 301): Exploratory Efficacy Results

Presented at the 2021 Virtual AAN Annual Meeting. April 17-21, 2021

Authors:

Sheena Aurora, Timothy Smith, Maria Jeleva, Jasna Hocevar-Trnka, John Hoekman, Stephen Shrewsbury

Objective:

To report the results of the exploratory, self-reported efficacy data for INP104 from the phase 3 study.

Background:

INP104 is being developed as a novel combination product delivering dihydroergotamine (DHE) mesylate to the upper nasal cavity using a Precision Olfactory Delivery (POD®) device. Phase 1 results showed IV DHE-like blood levels from 20 minutes to 48 hours with a lower C_max and a lower incidence of adverse events (AEs) than with IV DHE.

Design/Methods:

STOP 301 was a multicenter, open-label, 24-week study, with a subset extending treatment to 52-weeks; (NCT0355733). Patients completed a daily diary and a migraine diary with every attack during a 28-day screening (on “best usual care”) and then on treatment. Patients were allowed to self administer up to 3 doses/week of INP104 (1.45 mg) with migraine attacks. Exploratory objectives included patient reported efficacy measures compared to best usual care.

Results:

354 patients dosed INP104 at least once in the 24-week treatment period, and 73 patients continued into the 28 week extension period. 4,515 migraine attacks were treated with INP104 over 24-weeks. In the first migraine treated with INP104, pain freedom and relief at 2 hours was reported by 38% and 66% patients repectively and most bothersome symptom freedom by 52%. Sustained pain freedom over 24 and 48 hours was reported in 35% and 32% of patients respectively. 85% of the time there was no reported need for rescue (or second dose) for 48 hours. Most common TEAEs were: nasal congestion (15.0%), nausea (6.8%), nasal discomfort and unpleasant taste (5.1% each) with all other TEAEs being reported by < 3%. There were no treatment related SAEs reported. Nasal endoscopy and smell tests revealed no concerning changes.

Conclusion:

INP104 may provide well tolerated, clinically meaningful and sustained relief as an acute treatment for migraine when targeted to the upper nasal space.

Citation:

A long-term, open label Safety and Tolerability Study Of Precision Olfactory Delivery of DHE in Acute Migraine Treatment (STOP 301): Exploratory Efficacy Results (2490)
Sheena Aurora, Timothy Smith, Maria Jeleva, Jasna Hocevar-Trnka, John Hoekman, Stephen Shrewsbury
Neurology Apr 2021, 96 (15 Supplement) 2490;