The vice president of Medical Affairs in Migraine at Impel discussed the STOP 301 trial of intranasal DHE and how the safety profile offers a positive for patients who would use the agent on-demand.
“Patients underwent endoscopy, so looking at it anatomically with an upper nasal endoscopy, and we did not find any issues that were related to INP104… What is good for clinicians and patients is that adverse event reporting was just as sensitive as the findings. We didn’t find any permanent changes. The most common adverse event was nasal congestion.”
In the recent STOP 301 trial (NCT03557333) of INP104, an intranasal formulation of dihydroergotamine (DHE), data suggested over the long term that it has an acceptable safety profile, though safety should be monitored with intermittent use of the medication.
Nausea is often reported with high peak plasma DHE concentration by IV administration, so the investigators sought to determine the incidence of delivery with INP104’s nasal delivery system. They analyzed data from the full safety set of 354 patients from the STOP study. Of these patients, 36.7% (n = 130) reported at least 1 treatment-related, treatment-emergent adverse event (TEAE) during the 24-week treatment period.
Sheena Aurora, MD, Vice President, Medical Affairs – Migraine, Impel Neuropharma, gave presented these findings at the 2021 Virtual American Headache Society (AHS) 63rd Scientific Annual Meeting, June 3-6. In a conversation with NeurologyLive, Aurora shared more information about Impel’s novel approach to the molecule, delivered via a drug device in a dose of 1.45 mg administered to the upper nasal space using Precision Olfactory Delivery (POD) technology. She spoke to the safety profile and the clinical relevance of the safety findings.
For more coverage of AHS 2021, click here.