Abstract Details

Title Efficacy of Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) by Baseline Migraine-associated Disability: Post-hoc Analysis of the INTERCEPT Trial

Topic Headache

Presentation(s) P8 - Poster Session 8 (11:45 AM-12:45 PM)

Poster/Presentation
Number 15-012

Objective This post-hoc analysis evaluated whether baseline migraine disability, assessed by the Migraine Disability Assessment (MIDAS) scale, influenced outcomes in the Phase 3 INTERCEPT trial of Symbravo® (MoSEIC^TM meloxicam and rizatriptan) for acute treatment of migraine.

Background In the Phase 3 INTERCEPT trial, Symbravo increased rates of freedom from pain and the most bothersome symptom (MBS) versus placebo, and improved rates of return to normal function at 2 hours.

Design/Methods Participants were adults with migraine averaging 2–8 attacks/month over the prior 3 months. They were randomized (1:1) to treat a single attack with Symbravo or placebo taken as soon as possible after migraine pain onset, while pain was mild. Participants were stratified by baseline MIDAS score: little/no (score ≤5), mild (6–10), moderate (11–20), or severe (≥21) disability. Ability to perform normal function, pain freedom, freedom from MBS, and rescue medication avoidance were analyzed.

Results

Participants received Symbravo (n=132, mean age 41.6 years, 85.6% women) or placebo (n=135, 41.4 years, 85.2% women). Most reported moderate/severe disability at baseline (Symbravo n=108 [81.8%], placebo n=104 [78.8%]). Pre-treatment functional disability scores (0-3) were 1.3±0.67 (Symbravo) and 1.3±0.77 (placebo), indicating mild disability.

More participants could perform normal activity after 2 hours with Symbravo, with the greatest effects in the severe category (ARR vs placebo [95% CI]: 24.9% [9.6, 40.2]). More participants reported pain freedom at 2 hours post-dose with Symbravo (16.3% [6.1, 26.4]), with proportions consistent across subgroups. Freedom from MBS at 2 hours was more common in the severe (27.9% [11.8, 44.0]) vs lower disability subgroups, while avoidance of rescue medication was slightly more common in the mild subgroup (55.6% [32.6, 78.5]).

Conclusions In INTERCEPT, improvements in return to normal function with Symbravo were larger in participants with greater baseline disability, perhaps indicating a floor effect among those with minimal disability in the study population.

Authors/Disclosures
Todd Grinnell PRESENTER	Mr. Grinnell has received personal compensation for serving as an employee of Axsome Therapeutics. Mr. Grinnell has stock in Axsome Therapeutics.
Stewart J. Tepper, MD (The New England Institute for Neurology and Headache)	Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aeon. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbvie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aruene. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Atheneum. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Axsome Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Becker Pharmaceutical Consulting. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clearview Healhcare Partners. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for CoolTech. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for CRG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Decision Resources. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Defined Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DRG. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eli Lilly. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ExpertConnect. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FCB Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Fenix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GLG. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Advances. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Health Science Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for HMP Communications. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Impel. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for InteractiveForums. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Keyquest. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Krog and Partners. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Lundbeck. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Magnolia Innovation. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MJH Holdings. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurolief. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for P Value Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pain Insights Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Palion Medical. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pulmatrix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Putnam Associates. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SAI MedPartners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Satsuma. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Slingshot Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Spherix Global Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Strategy Inc. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for System Analytic. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Taylor and Francis. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Theranica. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Trinity Partners. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UnityHA. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for XOC. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Click Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Miravo. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurofront Therapeutics. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rehaler. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communications. Dr. Tepper has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Pfizer. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alphasights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Perfood. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for M3 Global Research. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Scilex. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Synapse Medical Communication. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tegus. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Catch Therapeutics. Dr. Tepper has received personal compensation in the range of $0-$499 for serving as a Consultant for DocDelta. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dr Reddy's. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for FCB Health. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gilmartin Capital. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Initiator Pharma. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Magellan Health. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Nocira. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Slingshot Insights. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Third Bridge. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Tonix. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vial . Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for DocDelta. The institution of Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bausch Health. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Dr Reddy's. The institution of Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biohaven. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Aeon. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abbvie. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for ClickTherapeutics. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CoolTech. Dr. Tepper 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. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Miravo Healthcare. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pulmatrix. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Satsuma. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Lundbeck. Dr. Tepper has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Pfizer. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Scilex. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Teva. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Tonix. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Dr Reddy's. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Eli Lilly. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Anneal. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Axsome. The institution of Dr. Tepper has received research support from Abbvie. The institution of Dr. Tepper has received research support from Aeon. The institution of Dr. Tepper has received research support from Amgen. The institution of Dr. Tepper has received research support from Annovis. The institution of Dr. Tepper has received research support from Axsome. The institution of Dr. Tepper has received research support from Cassava. The institution of Dr. Tepper has received research support from Cognition. The institution of Dr. Tepper has received research support from Eli Lilly. The institution of Dr. Tepper has received research support from Inibikase. The institution of Dr. Tepper has received research support from Ipsen. The institution of Dr. Tepper has received research support from Lundbeck. The institution of Dr. Tepper has received research support from Merz. The institution of Dr. Tepper has received research support from Pfizer. The institution of Dr. Tepper has received research support from PrecisionMed. The institution of Dr. Tepper has received research support from Revance. The institution of Dr. Tepper has received research support from Suven. The institution of Dr. Tepper has received research support from UCB. The institution of Dr. Tepper has received research support from Biohaven. The institution of Dr. Tepper has received research support from Johnson and Johnson/Intracellular. The institution of Dr. Tepper has received research support from Karuna. The institution of Dr. Tepper has received research support from Neurocrine. Dr. Tepper has received publishing royalties from a publication relating to health care. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a CME Speaker with Diamond Headache Clinic. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical Learning Institute Peerview. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Medical ��ɫ�� Speakers Network. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a CME Speaker with Miller Medical Communications. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME Speaker with Physicians' ��ɫ�� Resource. Dr. Tepper has received personal compensation in the range of $10,000-$49,999 for serving as a CME Speaker with WebMD/Medscape. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with American Headache Society. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with Vindico Medical ��ɫ��. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CME speaker with HMP Global. Dr. Tepper has received personal compensation in the range of $500-$4,999 for serving as a CMe speaker with Medical Learning Institute Peerview. Dr. Tepper has received personal compensation in the range of $5,000-$9,999 for serving as a Speaker with Consortium for Research ��ɫ�� Social Awareness and Training In Neurosciences.
Angad Chhabra	Angad Chhabra has nothing to disclose.
Graham M. Eglit, PhD	Dr. Eglit has received personal compensation for serving as an employee of Axsome Therapeutics Inc. Dr. Eglit has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Developmental Neuropsychology: A Life-Span Developmental Journal. Dr. Eglit has stock in Axsome Therapeutics.
Herriot Tabuteau (Axsome Therapeutics)	Herriot Tabuteau has received personal compensation in the range of $100,000-$499,999 for serving as an officer or member of the Board of Directors for Axsome Therapeutics.

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