Symbravo (meloxicam/rizatriptan) / Axsome Therap - LARVOL DELTA

Payer coverage for SYMBRAVO across all channels is at approximately 52% of all lives covered as of October 1. The proportions of lives covered in the commercial and government channels are approximately 48% and 56%, respectively. (GlobeNewswire)

Commercial • Migraine

Axsome Therapeutics Reports Third Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "AUVELITY net product sales were $136.1 million for the third quarter of 2025, representing 69% year-over-year growth, and 14% sequential growth compared to the second quarter of 2025. AUVELITY net product sales for the third quarter of 2024 were $80.4 million...SUNOSI net product revenue was $32.8 million for the third quarter of 2025, representing 35% year-over-year growth, and 9% sequential growth compared to the second quarter of 2025....SYMBRAVO net product sales were $2.1 million for the third quarter of 2025, the first full quarter of commercialization following its launch in June 2025."

Sales • Major Depressive Disorder • Migraine • Narcolepsy • Obstructive Sleep Apnea

Axsome Therapeutics Hosts Frontiers in Brain Health R&D Day Reviewing Industry-Leading Late-Stage CNS Pipeline (GlobeNewswire) - "Dr. Chadwick will provide an overview of fibromyalgia and of the previously completed Phase 2 and Phase 3 clinical trials of AXS-14 in the indication...Dr. Cummings will provide an overview of Alzheimer's disease (AD) agitation and discuss the results of the ADVANCE and ACCORD Phase 3 trials of AXS-05 in the indication...Cutler will provide an overview of attention deficit hyperactivity disorder (ADHD), major depressive disorder (MDD) with excessive daytime sleepiness (EDS), and excessive sleepiness associated with shift work disorder (SWD), and discuss the results of the FOCUS and PARADIGM Phase 3 trials of solriamfetol in ADHD and MDD, respectively...Dr. Tepper will provide an overview of migraine and will discuss results from the MOMENTUM and INTERCEPT Phase 3 trials of SYMBRAVO in the acute treatment of migraine with and without aura....Dr. Thorpy will provide an overview of narcolepsy and will discuss the results of the clinical trial program of AXS-12 in the indication."

Clinical data • Trial status • Alzheimer's Disease • Attention Deficit Hyperactivity Disorder • Excessive Daytime Sleepiness • Fibromyalgia • Major Depressive Disorder • Migraine • Narcolepsy • Psychiatry • Sleep Disorder

Commercial Highlights (GlobeNewswire) - "Payer coverage for AUVELITY in the commercial channel expanded by 28 million new covered lives as of July 1. Overall payer coverage for AUVELITY across all channels is now at approximately 83% of all lives covered, with the proportion of covered lives in the commercial and government (Medicare and Medicaid) channels at approximately 73% and 100%, respectively...Payer coverage for SUNOSI across all channels is at approximately 83% of all lives covered. The proportion of lives covered for SUNOSI in the commercial and government channels are approximately 95% and 60%, respectively...Effective July 1, Axsome has contracted with one of the three largest...(GPOs) for potential formulary coverage of SYMBRAVO....Payer coverage for SYMBRAVO across all channels is currently at approximately 38% of all lives covered. The proportion of lives covered in the commercial and government (Medicare and Medicaid) channels are currently approximately 26% and 56%, respectively."

Commercial • Major Depressive Disorder • Migraine • Narcolepsy • Obstructive Sleep Apnea

Axsome Therapeutics Reports Second Quarter 2025 Financial Results... (GlobeNewswire) - "AUVELITY net product sales were $119.6 million for the second quarter of 2025, representing 84% year-over-year growth, and 24% sequential growth compared to the first quarter of 2025. AUVELITY net product sales for the second quarter of 2024 were $65.0 million; SUNOSI net product revenue was $30.0 million for the second quarter of 2025, representing 35% year-over-year growth, and 19% sequential growth compared to the first quarter of 2025. SUNOSI net product revenue for the second quarter of 2025 consisted of $28.9 million in net product sales and $1.1 million in royalty revenue associated with SUNOSI sales in out-licensed territories....SYMBRAVO was launched on June 10, 2025, and had net product sales of $0.4 million for the second quarter of 2025. No SYMBRAVO sales were reported by Axsome for the comparable period in 2024 reflecting the timing of the product launch."

Sales • Major Depressive Disorder • Migraine • Narcolepsy • Obstructive Sleep Apnea

Neuroinflammatory crosstalk in migraine: consolidated activity of rizatriptan and meloxicam in suppressing CGRP-induced nociception and COX-mediated inflammation. (PubMed, Inflammopharmacology) - "We have explored the molecular basis, pharmacological interaction, and clinical effectiveness of SYMBRAVO in this study, with a focus on how it can improve effectiveness, reduce adverse reactions and overcome barriers to single drug therapy. The results support a paradigm change towards integrated migraine therapy strategies that emphasize controlled, multi-pathway regulation."

Journal • Review • CNS Disorders • Inflammation • Migraine • Pain

Meloxicam and Rizatriptan Benzoate. (PubMed, Am J Health Syst Pharm) - No abstract available

Journal

Long-term effects of Symbravo® (MoSEIC™ meloxicam and rizatriptan) on headache burden and quality of life: Results of the MOVEMENT trial (AHS 2025) - P3 | "Over an up to 12-month period, open-label mMR was well-tolerated and was associated with reduction in headache-related disability and headache impact, and with improvement in quality of life. Change from baseline in patient reported outcomes during acute treatment with mMR. HIT-6, headache impact test-6; MIDAS, migraine disability assessment; mMR, MoSEIC™ meloxicam and rizatriptan; MSQ, migraine-specific quality of life questionnaire."

HEOR • CNS Disorders • Migraine • Pain

Efficacy of Symbravo® (MoSEIC™ meloxicam and rizatriptan) by baseline migraine-associated disability: post-hoc analysis of the INTERCEPT trial (AHS 2025) - P3 | "Early treatment of migraine, when pain was still mild, with mMR, significantly improved ability to resume normal activity, migraine pain, MBS, and use of rescue medication vs. placebo. Improvements were generally more pronounced in participants with greater disability at baseline, which may have influenced the observed effect on return to normal function in the overall study population, although interpretation is limited by small sample size in some subgroups."

Clinical • Retrospective data • CNS Disorders • Migraine • Pain

Efficacy and safety of Symbravo® (MoSEICTM meloxicam and rizatriptan) in participants with migraine experiencing an inadequate response to oral CGRP inhibitors: Topline results from the EMERGE trial (AHS 2025) - P3 | "In the EMERGE trial in participants experiencing and inadequate response to gepants, treatment with mMR was associated with significant improvements in migraine treatment response, including higher rates of rapid and sustained relief and improved functional recovery, as assessed by the mTOQ-4, and quality of life. In this population, treatment with mMR was associated with rapid and sustained relief of migraine pain and associated symptoms, with efficacy experienced as early as 30 min post dose. These results align with findings from the prior phase 3 studies, providing additional evidence for the efficacy of mMR across a range of migraine patient populations with varying pain intensities and prior responses to acute treatments."

Clinical • CNS Disorders • Migraine • Pain

Axsome Therapeutics to Present Data Spanning the SYMBRAVO (meloxicam and rizatriptan) Clinical Program at the 67th Annual Scientific Meeting of the American Headache Society (AHS) (GlobeNewswire) - "Axsome Therapeutics, Inc...announced that data from across the SYMBRAVO (meloxicam and rizatriptan) clinical program will be presented at the 67th Annual Scientific Meeting of the American Headache Society (AHS), being held June 19-22, 2025, in Minneapolis, Minnesota."

Clinical data • Migraine

What to Do When Prior Acute Migraine Treatments Fail: Underlying Mechanisms and Treatment Approaches (AHS 2025) - "Current therapeutic options for acute migraine treatment include new drug classes (gepants, ditans), as well as novel delivery options of established drug classes (dihydroergotamine, triptans, NSAIDs). A newly approved therapeutic option is a multi-mechanistic approach that targets several pathophysiologic mechanisms through a novel formulation of meloxicam and rizatriptan combined in the same tablet. The symposium will highlight the pathophysiologic processes and multi-mechanistic approaches for acute treatment of migraine, including therapies to consider when previous acute treatments fail or when response is inadequate.Educational ObjectivesUpon completion of this activity, participants should be able to:• Identify central, peripheral, neuronal, and vascular pathophysiologic mechanisms involved in acute migraine pain• Explain the scientific rationale for multi-mechanistic targeting of pathophysiologic mechanisms of acute migraine in patients with inadequate response..."

CNS Disorders • Migraine • Pain

Axsome Therapeutics Announces Availability of SYMBRAVO (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults (Yahoo Finance) - "Axsome Therapeutics, Inc...announced that SYMBRAVO (meloxicam and rizatriptan) is now available by prescription in the United States for the acute treatment of migraine with or without aura in adults."

Launch US • Migraine

Axiom Therapeutics at Bank of America Conference: Strategic Growth Plans (Investing.com) - "On Tuesday, 13 May 2025, Axiom Therapeutics...presented at the Bank of America 2025 Healthcare Conference. The company shared a strategic overview highlighting both opportunities and challenges. Key discussions focused on...the upcoming launch of Symbravo for migraines."

Clinical • Migraine

Axsome Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Update (GlobeNewswire) - "Regulatory and Commercial: SYMBRAVO for the acute treatment of migraine, commercial launch (June 2025); AXS-14 for fibromyalgia, FDA filing acceptance decision (2Q 2025); AXS-05 for Alzheimer’s disease agitation, sNDA submission (3Q 2025); AXS-12 for narcolepsy, NDA submission (2H 2025)."

FDA filing • Launch • Alzheimer's Disease • Fibromyalgia • Migraine • Narcolepsy

A fixed-dose combination of meloxicam and rizatriptan (Symbravo) for migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Comparative Efficacy of AXS-07 vs. Gepants for Acute Treatment of Migraine: A Network Meta-Analysis (AAN 2025) - "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."

Retrospective data • CNS Disorders • Migraine • Pain

Axsome Therapeutics Announces SYMBRAVO (meloxicam and rizatriptan) Achieves Primary Endpoint in the EMERGE Phase 3 Trial in Migraine Patients Experiencing Inadequate Response to Oral CGRP Inhibitors (GlobeNewswire) - P3 | N=100 | EMERGE (NCT05550207) | Sponsor: Axsome Therapeutics, Inc. | "Pain freedom within 2 hours for most attacks was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 1.0% of patients after treatment with oral CGRPs (p<0.001). Sustained relief of migraine pain for at least 24 hours following a single dose of medication was reported half the time or more by 47.9% of patients after treatment with SYMBRAVO, compared to 16.7% of patients after treatment with oral CGRPs (p<0.001). The ability to quickly return to normal activities after taking their medication was reported half the time or more by 51.0% of patients after treatment with SYMBRAVO, compared to 11.5% of patients after treatment with oral CGRPs (p<0.001). The proportion of patients who reported being comfortable enough with their medication to be able to plan daily activities half the time or more was 63.5% after treatment with SYMBRAVO..."

P3 data • Migraine

Axsome Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Anticipated Milestones - Regulatory and Commercial: AXS-14 for fibromyalgia, NDA submission (1Q 2025)....AXS-12 for narcolepsy, NDA submission (2H 2025). Clinical Trial Topline Results: Phase 3 EMERGE trial of AXS-07 in migraine in patients with inadequate response to oral CGRP inhibitors (1Q 2025); Phase 3 FOCUS trial of solriamfetol in ADHD in adults (1Q 2025); Phase 3 PARADIGM trial of solriamfetol in major depressive disorder (1Q 2025); Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (2026); Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2026)."

P3 data: top line • Attention Deficit Hyperactivity Disorder • Binge Eating Disorder • Fibromyalgia • Major Depressive Disorder • Migraine • Narcolepsy

Axsome Therapeutics Hosts SYMBRAVO FDA Approval Virtual Investor Event with Expert Thought Leader (GlobeNewswire) - "Axsome Therapeutics, Inc...will host a virtual investor event and conference call today at 8:00 AM Eastern Time to discuss the U.S. Food and Drug Administration (FDA) approval of SYMBRAVO, a novel multi-mechanistic approach to treating migraine that targets multiple pathways underlying a migraine attack...During the call...will discuss the current migraine treatment landscape...The Axsome management team will provide an overview of SYMBRAVO and anticipated commercial plans."

Commercial • Migraine

Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE) (clinicaltrials.gov) - P3 | N=100 | Completed | Sponsor: Axsome Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

Axsome Therapeutics Announces FDA Approval of SYMBRAVO (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults (GlobeNewswire) - "Axsome Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has approved SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults....The Company expects SYMBRAVO to be commercially available in the U.S. in approximately four months....The FDA approval of SYMBRAVO is based on the results of the Phase 3 MOMENTUM trial that treated migraine of moderate and severe pain intensity, the Phase 3 INTERCEPT trial that treated migraine when the initial pain was mild, and the Phase 3 MOVEMENT long-term open label safety trial."

FDA approval • Migraine • Pain

Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine (GlobeNewswire) - "Axsome Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025."

FDA filing • PDUFA • CNS Disorders • Migraine • Pain

Axsome Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "The Company has resubmitted its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The Company expects the NDA resubmission to be designated as Class 2, which would be subject to a six-month review...The Company anticipates topline results from the EMERGE trial in the second half of 2024...Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024). Phase 3 ACCORD-2 trial of AXS-05 in Alzheimer’s disease agitation (2H 2024)."

FDA filing • P3 data • Alzheimer's Disease • CNS Disorders • Migraine • Pain

Combined efficacy and safety of AXS-07 (MOSEIC(TM) meloxicam and rizatriptan) in two phase 3 clinical trials (AHS 2024) - "Pooled analysis of MOMENTUM and INTERCEPT indicates that AXS-07 was effective at acutely treating migraine with a favorable tolerability profile."

Clinical • P3 data • CNS Disorders • Migraine • Musculoskeletal Pain • Pain