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Abstract Details

Combined Efficacy and Safety of AXS-07 (MOSEICTM Meloxicam and Rizatriptan) in Two Phase 3 Clinical Trials
Headache
P7 - Poster Session 7 (11:45 AM-12:45 PM)
12-002

To characterize the efficacy and safety profiles of AXS-07 in the acute treatment of migraine headache by pooling two phase 3 clinical studies.
AXS-07 is a rapidly absorbed, oral combination product consisting of MoSEIC™ meloxicam (20mg), a COX-2 preferential NSAID, and rizatriptan (10 mg), a 5 HT1B/1D agonist. The efficacy of AXS-07 was demonstrated in two clinical trials: MOMEMTUM, a 4-arm factorial study, and INTERCEPT, a 2-arm placebo-controlled trial.
MOMENTUM and INTERCEPT enrolled patients with an inadequate response to prior acute treatment into blinded, placebo-controlled studies. In MOMENTUM, participants were randomized to AXS-07, placebo, meloxicam (20mg), or rizatriptan (10mg) to treat a single migraine attack of moderate or severe intensity. In INTERCEPT, participants took AXS-07 or placebo at the earliest onset of migraine pain. Primary endpoints were pain freedom at 2 hours and freedom from most bothersome symptom (MBS).  Results from the two studies compared to placebo were pooled for the present analysis.
  In the pooled analysis, AXS-07 demonstrated greater headache pain freedom (23% vs 11%, p<0.001) and absence of MBS (39% vs 25%, p<0.001) at 2 hours compared to placebo. Participants taking AXS-07 demonstrated improved sustained pain freedom between 2 and 24 hours (18% vs 8%, p<0.001) and 48 hours (16% vs 7%, p<0.001) and had reduced rescue medication use through 24 hours (43% vs 21%, p<0.001) compared to placebo. More participants treated with AXS-07 returned to normal functioning in comparison with placebo starting at 1-hour post-dose.  Treatment-emergent adverse events (TEAEs) were experienced by 12.7% of participants taking AXS-07 compared to 6.6% on placebo. The most common TEAEs with AXS-07 were nausea, somnolence, and dizziness.

Pooled analysis of MOMENTUM and INTERCEPT indicates that AXS-07 was effective at acutely treating migraine with a favorable tolerability profile.
Authors/Disclosures
Stewart J. Tepper, MD (The New England Institute for Neurology and Headache)
PRESENTER 		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 好色先生 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' 好色先生 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 好色先生. 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 好色先生 Social Awareness and Training In Neurosciences.
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 as a Consultant for Axsome. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Clexio. Dr. Lipton has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shiratronics. 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 or had stock in Biohaven.Dr. Lipton has or had stock in Manistee.Dr. Lipton has or had stock in Axon.Dr. Lipton has or had 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.
Angad Chhabra Angad Chhabra has nothing to disclose.
Caroline Streicher (Axsome Therapeutics) Caroline Streicher has received personal compensation for serving as an employee of Axsome Therapeutics. Caroline Streicher has stock in Axsome Therapeutics.
Gregory S. Parks, PhD (Axsome Therapeutics) Dr. Parks has received personal compensation for serving as an employee of Axsome Therapeutics. Dr. Parks has received personal compensation for serving as an employee of Jazz Pharmaceuticals. Dr. Parks has stock in Axsome Therapeutics. Dr. Parks has stock in Jazz Pharmaceuticals.
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.