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Abstract Details

Treatment with Zavegepant Offers Improvements in Pain Severity Over 48-hours When Compared with Placebo—Post Hoc Results from a Randomized Placebo-controlled Trial (BHV3500-301)
Headache
P9 - Poster Session 9 (8:00 AM-9:00 AM)
12-007

To evaluate pain severity trajectories over 48-hours in subjects treating a single migraine attack with zavegepant 10mg nasal treatment (zavegepant) or placebo.

Migraine headaches consist of fluctuating degrees of pain, ranging from mild to severe. Zavegepant is the first and only FDA approved intranasal calcitonin gene-related peptide antagonist for the acute treatment of migraine. The efficacy and safety of zavegepant has been demonstrated in BHV3500-201; NCT03872453 and BHV3500-301; NCT04571060.

Eligible subjects for this post-hoc analysis were from BHV3500-301: a phase III double-blind, randomized, placebo controlled study. Subjects included adults with ≥1-year history of migraine. Pain severity data (0mins-48hrs) was measured on a 4-point Likert scale, from no to severe pain. Outcomes included the percentage of subjects by pain state and time point, and average time spent in each state across treatment arms over 48-hours. t-tests were conducted to determine differences between groups.

Among 1,269 subjects (zavegepant=623, placebo=646), pain severity distribution was similar at time 0, with all patients experiencing moderate/severe pain. No/mild pain was achieved among both groups as early as 15-minutes post-dose, but in a larger proportion of zavegepant patients  (16.5% vs 8.3%). At 1-hr 45.8% of zavegepant arm were experiencing no/mild pain vs. 38.6% on placebo. The proportion of patients experiencing moderate/severe pain continued to reduce in both study arms over 48-hrs. Averaging across subjects, the mean [standard deviation] time spent with no pain/mild pain was higher for zavegepant (36.8hrs [13.9]) vs. placebo (34.0hrs [15.4]). zavegepant subjects spent significantly less time in moderate/severe pain (11.2hrs [13.9]) compared to placebo subjects (14.0hrs [15.4]), p-value=0.001.

Acute treatment of a single migraine attack with nasal zavegepant was associated with an increased reduction in pain severity over 48-hours, when compared to placebo. zavegepant subjects spent more time in no/mild pain and less time in moderate/severe pain when compared with placebo.

Authors/Disclosures
Jessica Cirillo (Pfizer)
PRESENTER
Mrs. Cirillo has received personal compensation for serving as an employee of Pfizer. Mrs. Cirillo has stock in Pfizer.
Pramoda Jayasinghe No disclosure on file
Fiona O'Sullivan (Broadstreet HEOR) No disclosure on file
Evan Popoff No disclosure on file
Lauren Powell (Broadstreet HEOR) Lauren Powell has nothing to disclose.
Lucy Abraham (Pfizer R&D UK Ltd) Lucy Abraham has received personal compensation for serving as an employee of Pfizer R&D UK Ltd. Lucy Abraham has stock in Pfizer R&D UK Ltd.
Jessica Ailani, MD, FAAN (Medstar Georgetown Neurology) Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Ailani has received personal compensation in the range of $0-$499 for serving as a Consultant for Eli Lilly. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ipsen. Dr. Ailani has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merz. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aspya. Dr. Ailani has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amneal. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kallyope. Dr. Ailani has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Self Magazine. The institution of Dr. Ailani has received research support from Ipsen. The institution of Dr. Ailani has received research support from Parema. The institution of Dr. Ailani has received research support from Lundbeck. The institution of Dr. Ailani has received research support from Merz. The institution of Dr. Ailani has received research support from Pfizer. Dr. Ailani has received research support from Mi-Helper. The institution of Dr. Ailani has received research support from ShiraTronic. Dr. Ailani has a non-compensated relationship as a Executive Board Member with American Headache Society that is relevant to AAN interests or activities.