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Abstract Details

Zavegepant Nasal Spray for the Acute Treatment of Migraine With Aura and Without Aura: Pooled Results From 2 Randomized, Placebo-Controlled Clinical Trials
Headache
S47 - Advances in Migraine Therapeutics (1:36 PM-1:48 PM)
004

Zavegepant is the only small molecule CGRP receptor antagonist for intranasal administration in late-stage development for the acute treatment of migraine.

Compare the efficacy of zavegepant nasal spray with placebo in the acute treatment of migraine in participants with and without aura.

This post-hoc subgroup analysis is based on the pooled results of 2 randomized, double-blind clinical trials comparing the efficacy of a 10 mg dose of zavegepant nasal spray with placebo in the acute treatment of a single migraine attack of moderate to severe pain intensity (NCT03872453, NCT04571060). Subgroups reporting the presence or absence of predose aura were analyzed. The co-primary efficacy endpoints were pain freedom and freedom from most bothersome symptom (MBS) at 2 hours (2h) postdose.

In the pooled population (N=2061; zavegepant n=1014, placebo n=1047, mean age 40.8 years, 83.6% female), 688 (33.4%) participants had predose aura (zavegepant=320 [31.6%], placebo=368 [35.1%]), and 1373 (66.6%) had no predose aura (zavegepant=694 [68.4%], placebo=679 [64.9%]). Zavegepant was more effective than placebo on the co-primary endpoints in participants with predose aura (2h pain freedom: 23.1% vs 16.6%, nominal-p=0.0323, 2h MBS freedom: 37.5% vs 29.6%, nominal-p=0.0292) and without predose aura (pain freedom: 23.2% vs 14.3%, nominal-p<0.0001, MBS freedom: 41.9% vs 33.4%, nominal-p=0.0011). Zavegepant demonstrated benefit on pain relief as early as 15 minutes postdose in participants with predose aura (15.3% vs 7.9%, nominal-p=0.0024) and in participants without predose aura (17.4% vs 9.3%, nominal-p<0.0001). Zavegepant demonstrated significant benefit on pain relief at 2 hours postdose in participants with predose aura (60.6% vs 51.6%, nominal-p=0.0177) and in participants without predose aura (58.9% vs 51.0%, nominal-p=0.0029).

Zavegepant 10 mg nasal spray was effective and provided a rapid onset of action for the acute treatment of migraine regardless of the presence or absence of predose aura.

Authors/Disclosures
Timothy R. Smith, MD (Studymetrix Research, LLC)
PRESENTER
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.
Jelena M. Pavlovic, MD, PhD (Albert Einstein College of Medicine) Dr. Pavlovic has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven.
Kathleen B. Mullin, MD (NEINH) Dr. Mullin has received personal compensation in the range of $0-$499 for serving as a Consultant for Vorso. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Impel. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Mullin has received personal compensation in the range of $0-$499 for serving as a Consultant for Theranica. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biohaven. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Pfizer. Dr. Mullin has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for AbbVie.
Shivang Joshi, MD (Community Neuroscience Services) Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbvie. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Joshi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Lilly. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Currax. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Relivion. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nerivio. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axiome. Dr. Joshi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Joshi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Joshi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Abbvie. Dr. Joshi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Joshi has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Joshi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Teva. Dr. Joshi has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Impel. Dr. Joshi has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biohaven. The institution of Dr. Joshi has received research support from Lilly . The institution of Dr. Joshi has received research support from Biohaven. The institution of Dr. Joshi has received research support from Amgen.
Robert Croop, MD Dr. Croop has received personal compensation for serving as an employee of Biohaven Pharmaceuticals, Inc. Dr. Croop has received personal compensation for serving as an employee of Pfizer Inc.. Dr. Croop has stock in Biohaven Pharmaceutical Holding Co Ltd. Dr. Croop has stock in Biohaven Ltd.. Dr. Croop has received intellectual property interests from a discovery or technology relating to health care.
Jennifer Madonia (Biohaven Pharmaceuticals) Jennifer Madonia has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Jennifer Madonia has stock in Biohaven Pharmaceuticals.
Linda Mosher (Biohaven Pharmaceuticals) Mrs. Mosher has stock in Biohaven Pharmaceuticals. Mrs. Mosher has stock in Pfizer.
Meghan Lovegren Meghan Lovegren has received personal compensation for serving as an employee of Biohaven Pharmaceutials, Inc.. Meghan Lovegren has stock in Biohaven Pharmaceuticals, Inc..
Micaela Forshaw Micaela Forshaw has received personal compensation for serving as an employee of Biohaven Pharmaceuticals. Micaela Forshaw has received stock or an ownership interest from Biohaven Pharmaceuticals.
Richard B. Lipton, MD, FAAN (Albert Einstein College of Medicine) Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biohaven. Dr. Lipton has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GlaxoSmithKline. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Vedanta. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Grifols. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axon. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Satsuma. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cool Tech. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BDSI. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Linpharma. Dr. Lipton has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biohaven. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eli Lilly. Dr. Lipton has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Lundbeck. Dr. Lipton has stock in Biohaven. Dr. Lipton has stock in Manistee. Dr. Lipton has stock in Axon. Dr. Lipton has stock in CoolTech. The institution of Dr. Lipton has received research support from Teva. The institution of Dr. Lipton has received research support from Amgen. The institution of Dr. Lipton has received research support from Allergan/Abbvie. The institution of Dr. Lipton has received research support from Gammacore. The institution of Dr. Lipton has received research support from Axsome. The institution of Dr. Lipton has received research support from Charleston Labs. The institution of Dr. Lipton has received research support from Eli Lilly. The institution of Dr. Lipton has received research support from Satsuma. The institution of Dr. Lipton has received research support from NIH . The institution of Dr. Lipton has received research support from Veterans Administration. Dr. Lipton has received publishing royalties from a publication relating to health care.