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Abstract Details

Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis
Headache
P10 - Poster Session 10 (5:00 PM-6:00 PM)
12-006
To compare the efficacy of AXS-07 with gepants (rimegepant, ubrogepant, zavegepant) approved for acute migraine treatment in the United States using a network meta-analysis (NMA). 
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine to treat migraine, consisting of MoSEICTM (Molecular Solubility Enhanced Inclusion Complex) meloxicam and rizatriptan. The MOMENTUM (NCT0389600) phase 3 randomized, double-blind, single-dose, placebo-controlled trial demonstrated the efficacy and safety of AXS-07 in the acute treatment of migraine, with or without aura, in adults with a history of inadequate response to prior treatments. 
The analysis included MOMENTUM and 7 placebo-controlled phase 3 trials of the comparator drugs. A fixed effects Bayesian NMA was conducted focusing on 2-hour and 2-24 hour pain relief and pain freedom, absence of most bothersome symptoms (MBS), ability to perform normal activities at 2 hours, and use of rescue medications from 2-24 hours. Results were summarized with odds ratios (OR) and 95% credible intervals (CIs).
Compared to rimegepant, ubrogepant, and zavegepant, participants treated with AXS-07 were more likely to achieve 2-hour pain relief (OR [95% CI]: 1.06 [0.73-1.53], 1.10 [0.75-1.61], 1.33 [0.91-1.96]), 2-hour pain freedom (1.96 [1.07-3.78], 1.98 [1.07-3.89], 2.07 [1.13-4.06]), sustained 2-24 hour pain relief (1.11 [0.77-1.62], 1.02 [0.69-1.52], 1.66 [1.13-2.45]), and sustained 2-24 hour pain freedom (1.66 [0.85-3.51], 2.07 [1.04-4.46], 2.25 [1.14-4.83]). AXS-07 also showed greater absence of MBS (1.15 [0.78-1.73], 1.11 [0.73-1.69], 1.26 [0.84-1.92]), improved ability to perform normal activities at 2 hours (1.03 [0.68-1.58], 1.18 [0.77-1.82], 1.16 [0.75-1.81]), and reduced use of rescue medications from 2–24 hours (0.84 [0.57-1.23], 0.68 [0.43-1.10], 0.47 [0.32-0.71]). 
The NMA favors AXS-07 over rimegepant, ubrogepant, and zavegepant for acute migraine. AXS-07 is particularly effective in achieving 2-hour and 2-24 hour sustained pain freedom, offering a promising therapeutic alternative for patients with inadequate response to prior treatments.
Authors/Disclosures
Stephanie J. Nahas, MD, FAAN (Thomas Jefferson University)
PRESENTER 		Dr. Nahas has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for AbbVie. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Nahas has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Axsome. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amneal. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch Health. Dr. Nahas has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Ipsen. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received publishing royalties from a publication relating to health care. Dr. Nahas has received personal compensation in the range of $500-$4,999 for serving as a expert for CME activities with Medscape/WebMD. Dr. Nahas has a non-compensated relationship as a Board Member-at-Large with American Headache Society that is relevant to AAN interests or activities. Dr. Nahas has a non-compensated relationship as a Executive Board Member with The Headache Alliance that is relevant to AAN interests or activities.
yang zhao, PhD Dr. zhao has received personal compensation for serving as an employee of Axsome. Dr. zhao has stock in Axsome.
Christopher Graham, MS Mr. Graham has nothing to disclose.
Amanda Erbe Ms. Erbe has received personal compensation for serving as an employee of RTI Health Solutions.
Andrew M. Blumenfeld, MD, FAAN (Cedars Sinai) Dr. Blumenfeld has received personal compensation for serving as an employee of The Los Angeles Headache Center. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Best Doctors. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Guidepoint. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GLG. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Theranica. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Revance. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Pfizer. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Axsome. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Cedar Sinai. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Revance. Dr. Blumenfeld has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Theranica. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Axsome. Dr. Blumenfeld has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Teva. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lilly. Dr. Blumenfeld has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biohaven. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Lundbeck. Dr. Blumenfeld has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for AXSOME.