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

Drugs for acute treatment of migraine. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Migraine • Pain

Second Quarter 2026 Financial Highlights (The Manila Times) - "AUVELITY net product sales were $180.3 million for the second quarter of 2026, representing 51% year-over-year growth. AUVELITY net product sales for the comparable period in 2025 were $119.6 million....SYMBRAVO net product sales were $2.3 million for the second quarter of 2026, representing 461% year-over-year growth. SYMBRAVO was launched in June 2025 and had net product sales of $0.4 million for the second quarter of 2025."

Sales • Alzheimer's Disease • Migraine

Approximately 23,500 prescriptions were written for SYMBRAVO in the second quarter of 2026, a 30% increase compared to the first quarter of 2026. (The Manila Times) - "Payer coverage for SYMBRAVO across all channels is at approximately 57% of all lives covered, including approximately 56% of commercial lives and 57% of government lives."

Commercial • Migraine

Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) for the acute treatment of migraine: Post-hoc composite efficacy and safety endpoint analysis of INTERCEPT and MOMENTUM (AHS 2026) - "In two phase 3 clinical trials, treatment with MxRz was associated with improvement on responses using composite efficacy and safety endpoints compared with placebo or active control. These composite analyses assessed clinical response using more stringent response criteria to include prespecified efficacy thresholds in the context of no reported AEs. Both efficacy and safety are key considerations in treatment choice, so comparative assessments between MxRz, its components, and placebo further demonstrate the clinical value of MxRz."

Clinical • Retrospective data • CNS Disorders • Migraine • Pain

Comparative efficacy of Symbravo® versus gepants for acute treatment of migraine: A network meta-analysis (AHS 2026) - "Background: Symbravo® (20 mg MoSEIC(TM) meloxicam and 10 mg rizatriptan [MxRz]) is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine approved for acute treatment of migraine with or without aura. The NMA favors MxRz over rimegepant, ubrogepant, and zavegepant for acute migraine. MxRz is particularly effective in achieving 2-h and 2–24 h sustained pain freedom, offering a promising therapeutic alternative for patients with inadequate response to prior treatments."

Retrospective data • CNS Disorders • Migraine • Pain

Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) for the treatment of migraine: Sustained pain relief and pain freedom among 2-h responders in the phase 3 MOMENTUM and MOVEMENT trials (AHS 2026) - "Among participants with early response, treatment with MxRz was associated with higher rates of sustained pain relief and freedom through 24 and 48 h versus active comparators in MOMENTUM, suggesting that early response with MxRz was frequently associated with durable clinical benefit. Furthermore, this durability was consistently observed over multiple episodes in high proportions of participants. These findings will facilitate shared decision-making for clinicians and their patients when evaluating treatments for acute migraine and help better set expectations particularly in patients who are concerned about return of debilitating symptoms after initial response."

P3 data • CNS Disorders • Migraine • Pain

Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) for the acute treatment of migraine: Post-hoc composite efficacy and return to function endpoint analysis from MOMENTUM (AHS 2026) - P3 | "Treatment with MxRz was associated with improvement on a composite endpoint comprising migraine PR-RNF compared with placebo or active controls at multiple timepoints. Furthermore, at all time points, the probability of achieving composite endpoints was higher than that of achieving the regulatory recommended endpoint of pain freedom. Among participants with early response, treatment with MxRz was associated with higher rates of sustained PR-RNF through 24-h versus active comparators."

Clinical • Retrospective data • CNS Disorders • Migraine • Pain

Axsome Therapeutics Presents New SYMBRAVO Data at the Americal Headache Society (AHS) 68th Annual Scientific Meeting (GlobeNewswire)

Clinical data • Migraine • Pain

Eco-friendly appraised HPTLC strategy for the simultaneous determination of the newly approved meloxicam and rizatriptan mixture in their formulation. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "Compared with previously published LC methods, particularly UPLC, our strategy requires lower solvent consumption and reduced energy demand and generates less analytical waste owing to the simultaneous analysis of multiple samples on a single plate, while also offering greater operational simplicity. The ability to simultaneously estimate all analytes in a single TLC run cheaply renders our strategy efficient and well-suited for regular QC testing."

Journal • CNS Disorders • Migraine • Pain

First Quarter 2026 Financial Highlights (The Manila Times) - "AUVELITY net product revenue was $153.2 million for the first quarter of 2026, representing 59% year-over-year growth. AUVELITY net product sales for the comparable period in 2025 were $96.2 million...SYMBRAVO net product revenue was $4.1 million for the first quarter of 2026."

Sales • Alzheimer's Disease • Major Depressive Disorder • Migraine

Commercial Highlights (The Manila Times) - "Approximately 223,000 prescriptions were written for AUVELITY in the first quarter of 2026...The commercial launch of AUVELITY in Alzheimer’s disease agitation is on track for June 2026...Approximately 17,000 prescriptions were written for SYMBRAVO in the first quarter of 2026...Payer coverage for SYMBRAVO in the commercial channel expanded by 17 million new covered lives, effective May 2026. Overall payer coverage for SYMBRAVO across all channels is now at approximately 57% of all lives, with the proportion of covered lives in the commercial and government channels at approximately 56% and 57%, respectively."

Commercial • Launch US • Alzheimer's Disease • Dementia • Migraine

Efficacy and Safety of Symbravo® (MoSEIC(TM) Meloxicam and Rizatriptan) in Participants with Migraine Previously Treated with Oral CGRP Inhibitors: Topline Results from the EMERGE Trial (AAN 2026) - P3 | "Conclusions In EMERGE, Symbravo was associated with significant improvements in outcomes in participants with an mTOQ-4 score ≤7 while previously taking gepants, including greater symptom relief, functional recovery, and quality of life. Together with prior studies, these findings support the efficacy of Symbravo across diverse patient populations."

Clinical • CNS Disorders • Migraine • Pain

Long-term Effects of Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) on Headache Burden and Quality of Life: Results of the MOVEMENT Trial (AAN 2026) - "The most common AEs were nausea (5.7%), vomiting (4.7%), dizziness (3.1%), somnolence (2.8%), diarrhea (2.3%), and upper respiratory tract infection (2%). Conclusions Over a maximum 12-months, open-label Symbravo was well-tolerated and associated with improvements in headache-related disability, headache impact, and QoL."

HEOR • CNS Disorders • Infectious Disease • Migraine • Pain • Respiratory Diseases

Efficacy of Symbravo® (MoSEIC(TM) meloxicam and rizatriptan) by Baseline Migraine-associated Disability: Post-hoc Analysis of the INTERCEPT Trial (AAN 2026) - "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."

Clinical • Retrospective data • CNS Disorders • Migraine • Pain

Approximately 13,000 prescriptions were written for SYMBRAVO in the fourth quarter of 2025, representing a 147% increase compared to the third quarter of 2025. (The Manila Times) - "Payer coverage for SYMBRAVO across all channels is currently at approximately 52% of all lives. The proportion of lives covered in the commercial and government channels are approximately 49% and 57%, respectively."

Commercial • Migraine

SYMBRAVO 4Q and full year 2025 net product sales of $4.1 million and $6.6 million, respectively (The Manila Times)

Sales • Migraine

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