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Abstract Details

Long-Term Safety and Tolerability of Zavegepant 10 mg Nasal Spray During Concomitant Use of CGRP Monoclonal Antibodies: Results From a 1-Year Open-label Safety Trial
Headache
P10 - Poster Session 10 (8:00 AM-9:00 AM)
2-009

Patients receiving preventive treatment for migraine usually also require acute prescription migraine treatment. Zavegepant nasal spray is a small molecule CGRP receptor antagonist for the acute treatment of migraine. Given mechanistic overlap of zavegepant and CGRP targeted mAbs, characterizing safety of concomitant administration merits exploration.

Evaluate the effects of concomitant use of CGRP monoclonal antibodies (mAbs) on the safety and tolerability of zavegepant nasal spray in the acute treatment of migraine.

This subgroup analysis is based on a Phase 2/3, 1-year open-label safety study (NCT04408794) of zavegepant 10 mg nasal spray for the acute treatment of migraine. Adults aged ≥18 years with a history of 2 to 8 moderate-severe monthly migraine attacks were eligible. A stable dose of a CGRP mAb for preventive treatment of migraine was permitted during open-label zavegepant treatment.

Of the 603 subjects treated with zavegepant 10 mg nasal spray, 39 (6.5%) reported current or concomitant use of a CGRP mAb (erenumab 22, galcanezumab 11, fremanezumab 7); 564 (93.5%) did not use a CGRP mAb. The incidence of AEs on treatment was comparable in subjects using and not using a CGRP mAb (76.9% vs 76.2%). The most common AEs occurring in subjects using a CGRP mAb were dysgeusia [28.2% (11/39)], nasal discomfort [15.4% (6/39)], back pain [15.4% (6/39)], throat irritation [12.8% (5/39)], and arthralgia [12.8% (5/39)]. No serious AEs were reported in any subjects using a CGRP mAb. The rate of discontinuation due to AEs was similar in those using and not using a CGRP mAb (7.7% vs 6.7%). No new safety concerns were identified.

Up to 1 year of open-label treatment with zavegepant 10 mg nasal spray was safe and tolerable for the acute treatment of migraine whether or not subjects were concomitantly using CGRP mAbs for preventive treatment.

Authors/Disclosures
Gary D. Berman, MD
PRESENTER
Dr. Berman has received personal compensation for serving as an employee of Clinical Research Institute. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alder. Dr. Berman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Berman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lilly. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Allergen. Dr. Berman has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau 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.
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.
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.
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.
Jennifer D. Hould, Other (Biohaven) Ms. Hould has received personal compensation for serving as an employee of Biohaven . Ms. Hould has stock in Biohaven .
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.