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Abstract Details

A long-term, open label Safety and Tolerability Study Of Precision Olfactory Delivery of DHE in Acute Migraine Treatment (STOP 301): Exploratory Efficacy Results
Headache
Headache Posters (7:00 AM-5:00 PM)
013

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 Cmax and a lower incidence of adverse events (AEs) than with IV DHE.

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

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.

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.

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

Authors/Disclosures
Sheena K. Aurora, MD (Department of Neurology and Neurological Sciences)
PRESENTER
Dr. Aurora has received personal compensation for serving as an employee of Impel Neuropharma. Dr. Aurora has stock in Impel Neurpharma.
Timothy R. Smith, MD (Studymetrix Research, LLC) The institution of Dr. Smith has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Nocira. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vorso/Nesos. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alder/Lundbeck. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. The institution of Dr. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lilly. The institution of Dr. Smith has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurolief. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Nocira. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. The institution of Dr. Smith has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. The institution of Dr. Smith has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Abbvie/Allergan. The institution of Dr. Smith has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. The institution of Dr. Smith has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Smith has stock in United Health Group. The institution of Dr. Smith has received research support from Aeon. The institution of Dr. Smith has received research support from Alder/Lundbeck. The institution of Dr. Smith has received research support from Alnylam. The institution of Dr. Smith has received research support from Amgen. The institution of Dr. Smith has received research support from Abbvie/Allergan. The institution of Dr. Smith has received research support from Biohaven. The institution of an immediate family member of Dr. Smith has received research support from Eliem Pharmaceuticals. The institution of Dr. Smith has received research support from Lilly. The institution of Dr. Smith has received research support from Pfizer. The institution of Dr. Smith has received research support from Nocira. The institution of Dr. Smith has received research support from Novo Nordisk. The institution of Dr. Smith has received research support from Teva. The institution of Dr. Smith has received research support from Theranica. The institution of Dr. Smith has received research support from Vorso/Nesos. Dr. Smith has a non-compensated relationship as a Board Member with National Headache Foundation that is relevant to AAN interests or activities.
Maria Jeleva Maria Jeleva has received personal compensation for serving as an employee of Impel NeuroPharma.
Jasna Hocevar-Trnka Jasna Hocevar-Trnka has received personal compensation for serving as an employee of Impel NeuroPharma.
John *use 387100 Hoekman John Hoekman has received personal compensation for serving as an employee of Impel Neuropharma. John Hoekman has received stock or an ownership interest from Impel Neuropharma. John Hoekman has received intellectual property interests from a discovery or technology relating to health care.
Stephen Bevan Shrewsbury, MD (Impel Pharmaceuticals) Dr. Shrewsbury has received personal compensation for serving as an employee of Impel NeuroPharma. Dr. Shrewsbury has received stock or an ownership interest from Impel NeuroPharma.