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

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

axsome therapeutics reports first quarter 2024 financial results and provides business update (Axsome Therapeutics Press Release) - "'Our Phase 3 ADVANCE-2 trial of AXS-05 in Alzheimer’s disease agitation remains on track for completion in the second half of 2024. Further, we added to the robustness of this clinical development program with the initiation of the ACCORD-2 study of AXS-05 in Alzheimer’s disease agitation, a Phase 3 randomized withdrawal trial, for which we expect to complete enrollment mid-year 2024.'...AXS-07 for migraine, NDA resubmission (2Q 2024)..."

Enrollment status • NDA • Trial completion date • Alzheimer's Disease • CNS Disorders • Migraine • Pain

Axsome Therapeutics Highlights Innovative Neuroscience Portfolio at the American Academy of Neurology (AAN) 2024 Annual Meeting (GlobeNewswire) - "Axsome Therapeutics, Inc...today announced presentations highlighting its innovative psychiatry and neurology pipeline at the American Academy of Neurology (AAN) 2024 annual meeting, being held April 13-18, 2024, in Denver, Colorado. The presentations include an oral presentation during the Clinical Trials Plenary Session of data from the ACCORD Phase 3 trial of AXS-05 in Alzheimer’s disease agitation (ADA). Presentations related to the AXS-07 clinical program in migraine include new pooled efficacy data from the MOMENTUM and INTERCEPT Phase 3 trials. Additionally, there will be data presentations on cognition and sleep from the solriamfetol clinical program."

Clinical data • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Migraine • Pain

EMERGE Study: An Open-label Evaluation of the Efficacy and Safety of AXS-07 (MoSEIC™ meloxicam-rizatriptan) for Migraine in Adults with Prior Inadequate Response to an Oral CGRP Inhibitor (AAN 2024) - P3 | "Participants must have been using an oral CGRP inhibitor (rimegepant or ubrogepant). This is the first study to investigate the effects of AXS-07 in patients with inadequate response to oral CGRP inhibitors, a difficult to treat patient population."

Clinical • CNS Disorders • Migraine • Pain • ICAM3

Combined Efficacy and Safety of AXS-07 (MOSEICTM Meloxicam and Rizatriptan) in Two Phase 3 Clinical Trials (AAN 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 • Pain

Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Manufacturing activities related to the planned resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine continue to progress. The Company continues to anticipate resubmission of the NDA in the first half of 2024. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review."

NDA • CNS Disorders • Migraine • Pain

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 | Recruiting | Sponsor: Axsome Therapeutics, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CNS Disorders • Migraine • Pain

Axsome Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "AXS-07 (MoSEIC meloxicam-rizatriptan) is Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine. Migraine: Manufacturing activities related to the planned resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine continue to progress. The Company continues to anticipate resubmission of the NDA in the first half of 2024. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review."

NDA • CNS Disorders • Migraine • Pain

Axsome Therapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "AXS-05....Based on current enrollment trends, the Company continues to anticipate completion of ADVANCE-2 in the first half of 2024....AXS-07....Migraine: Manufacturing activities related to the planned resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine are progressing. The Company now anticipates resubmission of the NDA in the first half of 2024."

NDA • Trial completion date • Alzheimer's Disease • CNS Disorders • Migraine • Pain

Axsome Therapeutics to Present Five Abstracts Including New Data from the Positive SHARP Study of SUNOSI (solriamfetol) in Participants with Cognitive Impairment with Excessive Daytime Sleepiness in Obstructive Sleep Apnea at the 2023 American Academy of Neurology (AAN) Annual Meeting (GlobeNewswire) - "Axsome Therapeutics, Inc...announced that it will be presenting five abstracts at the upcoming 2023 American Academy of Neurology (AAN) Annual Meeting, being held from April 22-27 in Boston. These presentations include new data from the SHARP study....Additional presentations at the AAN conference highlight data on the TAAR1 agonist mechanism of action of solriamfetol, data from the ongoing SURWEY real-world experience study of Sunosi, as well as data on AXS-07, Axsome’s novel, oral, rapidly absorbed, multi-mechanistic, investigational medicine for the acute treatment of migraine."

Clinical data • P4 data • Real-world evidence • CNS Disorders • Excessive Daytime Sleepiness • Migraine • Obstructive Sleep Apnea • Pain • Psychiatry • Sleep Apnea • Sleep Disorder

Efficacy of AXS-07 (MOSEIC™ Meloxicam and Rizatriptan) in Patients with Risk Factors for Inadequate Response to Acute Migraine Medications (AAN 2023) - "Results Pooled 2-hour PF rates, stratified by risk factors for inadequate response for AXS-07 (N=560) and placebo (N=344), respectively, were: 19.1% vs. 9.9% (p=0.004) for BMI ≥ to the median BMI (28.8 kg/m2), 23.3% vs. 11.0% (p<0.001) for presence of allodynia, 23.5% vs. 10.5% (p<0.001) for morning migraine, and 23.1% vs. 5.9% (p=0.004) for history of depression.The most common adverse events reported in the AXS-07 group were nausea (2.4%), somnolence (2.1%), and dizziness (1.9%). Conclusions Among patients with documented risk factors for non-response to acute migraine medication, treatment with AXS-07 resulted in a statistically significant greater percentage of patients achieving 2-hour pain freedom compared to placebo."

Clinical • CNS Disorders • Depression • Migraine • Pain • Psychiatry

Identifying Areas of Unmet Need Among People with Migraine with an Inadequate Response to Prior Acute Therapies: Results from the MOMENTUM trial (AAN 2023) - "Design/Methods The Phase 3 MOMENTUM trial (N=1594) assessed the efficacy and safety of AXS-07 (MoSEIC™ meloxicam and rizatriptan), meloxicam alone, rizatriptan alone, and placebo in a 4-arm acute migraine treatment trial...Conclusions Between 29-43% of people with migraine rarely or never experience a positive efficacy response to each of the four mTOQ domains. Novel therapies that provide sustained pain freedom and improve the perceived ability to plan daily activities are particularly needed."

CNS Disorders • Migraine • Pain

Axsome Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (GlobeNewswire) - "Migraine: Manufacturing activities related to the planned resubmission of the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine are ongoing. The Company anticipates resubmission of the NDA in the second half of 2023. No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA. The Company expects the NDA resubmission to be designated as Class 2 which would be subject to a six-month review."

Commercial • NDA • CNS Disorders • Migraine • Pain

Axsome Therapeutics Announces Plans to Resubmit AXS-07 NDA Based on Successful FDA Type A Meeting (GlobeNewswire) - "Axsome Therapeutics, Inc...announced that, following a Type A meeting with the U.S. Food and Drug Administration (FDA), it intends to resubmit its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine in the third quarter of 2023. The purpose of the Type A meeting was...to address the issues raised in the previously received Complete Response Letter (CRL) to support a resubmission of the AXS-07 NDA. The issues principally related to chemistry, manufacturing, and controls (CMC) considerations. Based on the FDA feedback, the Company will include new CMC information, including stability data on newly manufactured commercial scale batches of AXS-07, in its resubmission package. The resubmission package may also include additional clinical pharmacology information....No additional clinical efficacy or safety trials have been requested by the FDA for a resubmission of the NDA."

FDA event • NDA • CNS Disorders • Migraine • Pain

"$AXSM following a Type A meeting with the FDA it intends to resubmit its NDA for AXS-07 for the acute treatment of migraine in Q3'23." (@BioStocks)

NDA • CNS Disorders • Migraine