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Exablate Neuro is a noninvasive, MRI-guided focused ultrasound technology designed to treat targeted brain areas without incisions or implanted hardware, offering a lower-risk alternative to traditional surgery.

Exablate Neuro Gains FDA Approval for Staged Bilateral Focused Ultrasound in Advanced Parkinson Disease 

The updated donanemab dosing schedule is aimed at reducing ARIA risk while maintaining efficacy in early Alzheimer treatment to enhance patient safety.

FDA Approves Updated Label for Alzheimer Therapy Donanemab to Lower ARIA-E Risk

Videos

The director of movement disorders at the Banner Sun Health Research Institute discussed distinguishing atypical Parkinsonian disorders early and planning care around their complex symptomatology. [WATCH TIME: 4 minutes]

Why Early Identification of Atypical Parkinsonian Syndromes Matters in the Clinic: David Shprecher, DO, MSci, FAAN

The chief medical officer and scientific officer at Harmony Biosciences discussed the pharmacologic rationale and preclinical development of BP1.15205, a novel orexin receptor agonist for hypersomnolence.

NeuroVoices: Kumar Budur, MD, MS, on BP1.15205 as a Next-Gen Therapy for Narcolepsy

Marco Meglio, Assistant Managing Editor for 

, has been with the team since October 2019. Follow him on Twitter 

Laren Becker, MD, PhD, a physician-scientist at Stanford University, discussed how gastrointestinal dysfunction and peripheral dopaminergic activity impact Parkinson disease treatment and progression.

Recognizing Gastrointestinal Symptoms as Early Indicators of Parkinson Disease

Continuous subcutaneous apomorphine infusion significantly reduces OFF episodes and enhances ON time in Parkinson's disease patients, improving overall health status.

Reduction in Parkinson OFF Episodes Through Subcutaneous Apomorphine Infusion Leads to Doubling of Good ON Time

Nurse practitioner in the Center for Movement Disorders & Neurorestoration at the University of Florida.

The nurse practitioner in the Center for Movement Disorders & Neurorestoration at the University of Florida discussed a complex case of childhood-onset dystonia treated with DBS. [WATCH TIME: 6 minutes]

Revisiting Deep Brain Stimulation in a Pediatric-Onset Dystonia Case: Pamela Zeilman, NP

, has been with the team since September 2022. Follow her on Twitter 

A physician assistant specializing in Parkinson disease shared key clinical considerations for selecting and educating patients about on-demand therapies for the movement disorder.

NeuroVoices: Cheryl Kyinn, PA-C, on Personalizing On-Demand Therapies for OFF Episodes in Parkinson Disease

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Clinical

 Migraine Disease Spotlight page offers specific updates and coverage on the latest expert conversations and data readouts related to the treatment and management of patients with migraine disorders.

A recent survey reveals rimegepant's effectiveness for short-term migraine prevention, highlighting user demographics, triggers, and treatment strategies.

Survey Data Highlights Real-World Use of Rimegepant for Short-Term Migraine Prevention

Chia-Chun Chiang, MD, associate professor of neurology at Mayo Clinic Rochester, discussed how AI-based ECG and imaging tools can aid in predicting stroke and cardiovascular outcomes in patients with migraine.

Using AI to Assist in Identifying Cardiovascular Risk in Patients With Migraine

Jennifer Robblee, MD, MSc, headache neurologist at the Barrow Neurological Institute, talked about an expert panel that developed a consensus definition for refractory migraine.

Defining Refractory Migraine for Diagnosis: Insights from an International Delphi Consensus

Nathaniel M. Schuster, MD, associate clinic director at the UC San Diego, talked about findings from a study of vaporized cannabis in treating patients with acute migraine presented at AHS 2025. 

Final Analyses Highlight Efficacy of THC-CBD Combination Therapy for Acute Migraine

Laura Sebrow, PhD, a post doctoral neuropsychology fellow at North Shore University Hospital, discussed the relationship between patients’ reported cognitive difficulties and measurable cognitive performance during different migraine phases.

Exploring Cognitive Difficulties in Migraine: Aligning Subjective and Objective Findings

The professor and chair of neurology at the University of South Carolina discussed findings from a study recently presented at AHS 2025 that linked migraine to autonomic dysfunction, increased risk of atrial fibrillation, and cardioembolic stroke.

Insights on Migraine, Autonomic Dysfunction, and Stroke Risk from the ARIC Study: Souvik Sen, MD, MPH, FAHA

“We were able to get data which suggest that people who have migraine with or without aura, they both have what is called a cerebral autonomic dysfunction, meaning the brain is not able to control the heart rate as well as somebody who does not have headache.”

Heart rate variability (HRV) is known as a well-established marker of autonomic nervous system function. In recent emerging evidence, studies have linked migraine with aura to an increased likelihood of developing atrial fibrillation, the most common cause of cardioembolic ischemic stroke. Notably, research has reported that low HRV has also been associated with a heightened risk of atrial fibrillation. Recent data from the Atherosclerosis Risk in Communities (ARIC) study further supported this connection, revealing a stronger correlation between reduced HRV and migraine with aura.

2025 American Headache Society (AHS) Annual Meeting

, held June 19-22, in Minneapolis, Minnesota, stroke neurologist Souvik Sen, MD, MPH, FAHA, delivered a presentation expanding on this topic. His session explored whether reduced HRV in patients with migraine, particularly those with aura, could reflect chronic autonomic dysfunction. Building on established links between HRV, atrial fibrillation, and stroke, Sen examined whether autonomic imbalance could represent the missing biological connection between migraine and increased cardioembolic stroke risk.

, Sen, professor and chair of the Department of Neurology at the University of South Carolina, discussed the ARIC study's findings in greater depth. He noted that analysis demonstrated that individuals with migraine, regardless of aura status, exhibited signs of cerebral autonomic dysfunction and lower HRV. In the interview, he highlighted this as a potentially underrecognized mechanism contributing to stroke risk, particularly among younger women. Sen also underscored the clinical potential of early HRV monitoring as a proactive strategy to identify and protect high-risk individuals before a stroke occurs.

Click here for more coverage of AHS 2025.

REFERENCES
1. Sen S. Test Role Of Heart Rate Variability (HRV) In Predicting Atrial Fibrillation and Ischemic Stroke In Migraine (CL). Presented at: 2025 AHS Annual Meeting; June 19-22; Minneapolis, MN. Plenary Session 2: STROKE.



The chair of neurology at the University of South Carolina discussed findings from a study recently presented at AHS 2025 that linked migraine to autonomic dysfunction, increased risk of atrial fibrillation, and cardioembolic stroke. [WATCH TIME: 5 minutes]

The neurologist and headache specialist at the Montreal Neurological Clinic spoke about a recent national survey presented at AHS 2025 that revealed insightful patient perspectives in migraine. 

Patients Voicing Key Needs for Migraine Care and Advocacy: Elizabeth W. Leroux, MD, FRCPC

"The key messages were about empowerment, breaking down stigma, seeking care, gaining access to care, and continuing to try new treatment options. I think this is an encouragement for us that, first, our strategic plan is good—so we’ll keep working."

Prior research has reported that migraine affects approximately between 8.3% and 10.2% of Canadians, with the highest prevalence observed during prime working years. It is also known as a leading cause of disability in those aged under 50 years.

 The condition can carry a substantial humanistic and economic burden because of its association with chronic conditions, reduced work productivity, and increased health care use. Both pharmacological treatments and nonpharmacological approaches, such as cognitive behavioral therapy and exercise, have been shown to help alleviate symptoms and improve health-related quality of life.

, held June 19-22, in Minneapolis, Minnesota, Elizabeth W. Leroux, MD, FRCPC, presented findings from a qualitative analysis of survey responses from 1119 Canadians living with migraine.

 Participants in the survey offered personal messages and advice directed toward 3 key groups which included young individuals beginning their migraine journey, health care professionals, and policy makers. In the session, Leroux highlighted common patient-driven themes such as the need for compassionate care, greater recognition of migraine as a serious condition, and improved access to treatment.

Leroux, a neurologist and headache specialist at the Montreal Neurological Clinic, sat down for an interview with 

during the meeting to provide greater depth on the results from the nationwide survey. In the conversation, she noted that the survey captured both quantitative and qualitative data. She talked about the common themes that the open-ended responses revealed from the survey, offering insights into the importance of listening to patient voices and using their lived experiences to inform clinical practice, advocacy efforts, and health policy planning.

REFERENCES
1. Tam ACT, Naik H, Trenaman L, Lynd L, Zhang W. Health-related quality of life among women and men living with migraine: a Canada-wide cross-sectional study. J Headache Pain. 2024;25(1):170. Published 2024 Oct 9. doi:10.1186/s10194-024-01882-4
2. Leroux EW. A thematic analysis of 1119 Canadian livings with migraine: advice and key messages for young people with migraine, health care providers, and policy makers. Presented at: 2025 AHS Annual Meeting; June 19-22; Minneapolis, MN. OR-08. 

The neurologist and headache specialist at the Montreal Neurological Clinic spoke about a recent national survey presented at AHS 2025 that revealed insightful patient perspectives in migraine. [WATCH TIME: 5 minutes]

FDA Approval of CT-132

"The additional drop in monthly migraine days and the improvements in patient-reported outcomes, without added side effects, make this a very dramatic advance."

Episodic migraine is a common neurological condition affecting a significant portion of the global population. It is estimated that 12-15% of adults experience migraine headaches, with the majority of these being episodic. Earlier this month, the FDA approved a new therapeutic, CT-132 (Click Therapeutics), as the first digitally-based prescription treatment for adults with episodic migraine, marking a significant milestone for the migraine community.

CT-132, an app-based intervention, integrates multiple evidence-based behavioral techniques, including elements of cognitive behavioral therapy, over a 12-week period. It is indicated for patients aged 18 years and older, intended for adjunctive use alongside acute and/or other preventive treatments for migraine. For context, data from 2, double-blind, decentralized randomized trials, ReMMi-D (NCT05853900) and ReMMiD-C (NCT06004388), served as the basis for the approval.

As the clinical community welcomes this new medication, 

 sat down with migraine expert Stewart Tepper, MD, to discuss the considerations amid its rollout, and what clinicians and patients should understand going forward. Tepper, a professor of neurology at the Geisel School of Medicine at Dartmouth, spoke on the lack of awareness surrounding digital therapeutics, underscoring efforts to accelerate education through publications, CME activities, and professional society initiatives. In addition, he noted that while no new trials are underway yet, Tepper expressed optimism about future studies, particularly in chronic migraine, guided by the platform’s strong clinical foundations.

REFERENCE
1. Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States. News release. Click Therapeutics. April 15, 2025. Accessed April 28, 2025. https://www.biospace.com/press-releases/click-therapeutics-announces-fda-marketing-authorization-for-ct-132-the-first-prescription-digital-therapeutic-for-the-preventive-treatment-of-episodic-migraine-in-the-united-states

The FDA has approved CT-132, a digital therapeutic app for episodic migraine, marking a significant advancement in migraine treatment. This app-based intervention, designed for adults, incorporates cognitive behavioral therapy techniques over 12 weeks and is intended for use alongside other migraine treatments. Clinical trials, ReMMi-D and ReMMiD-C, supported its approval. Migraine expert Stewart Tepper emphasizes the need for increased awareness and education about digital therapeutics. While no new trials are currently planned, there is optimism for future studies, particularly in chronic migraine.

The professor of neurology at the Geisel School of Medicine at Dartmouth discussed the clinical rollout of CT-132, a newly FDA-approved digital therapeutic for migraine, and the educational needs facing the neurology community. [WATCH TIME: 4 minutes]

Rolling Out CT-132 Lessons and Opportunities in Migraine Care: Stewart Tepper, MD

The director of the UCLA Goldberg Migraine Program discussed the advantages, evidence base, and evolving payor support for CGRP-targeting therapies as potentially a first-line option in migraine prevention. 

CGRP Therapies as Potential First-Line Migraine Preventive Treatment: Andrew Charles, MD

"These are the first preventive therapies that have been developed specifically for migraine based on a really solid foundation of science."

In April 2024, the American Headache Society (AHS) updated its position statement on calcitonin gene-related peptide (CGRP)-

targeting therapies for migraine prevention

 Unlike previous first-line therapies, which were initially developed for other conditions, CGRP-targeting treatments were specifically designed based on a solid foundation of evidence demonstrating CGRP’s crucial role in migraine pathogenesis. These therapies, including monoclonal antibodies, have shown to significantly improve migraine management, but they are still not universally considered as first-line options.

, a review of extensive clinical trial data, post hoc analyses, and real-world experience indicated that CGRP-targeting therapies outperform previous preventive treatments in terms of efficacy, tolerability, and safety.

 The studies suggested that these therapies are as effective, if not more so, than traditional first-line options, with serious adverse events being rare. As a result, the AHS recommended considering CGRP-targeting therapies as a first-line preventive treatment for migraine, without requiring prior failure of other treatments.

2025 American Academy of Neurology (AAN) Annual Meeting

, held April 5-9, in San Diego, California, 

, director of the UCLA Goldberg Migraine Program, presented a talk on why CGRP antagonists should be first-line migraine treatments.

 about the differences between acute and preventive treatments, emphasizing the superior efficacy, tolerability, and safety of CGRP therapies compared with traditional options. He also noted growing payer support for these therapies as first-line options, backed by strong clinical trial and real-world data.

Click here for more coverage of AAN 2025.

REFERENCES
1. American Headache Society publishes updated guidance on migraine preventive therapy. American Headache Society. March 11, 2024. Accessed April 6, 2025. https://www.prnewswire.com/news-releases/american-headache-society-publishes-updated-guidance-on-migraine-preventive-therapy-302085761.html
2. Charles AC, Digre KB, Goadsby PJ, Robbins MS, Hershey A. Calcitonin gene-related peptide-targeting therapies are a first-line option for the prevention of migraine: an American Headache Society position statement update. 

Published March 11, 2024. doi:10.1111/head.14692
3. Charles A. Yes: Should CGRP Antagonists Be First Line for Migraine Treatment?. Presented at: 2025 AAN Annual Meeting; April 5-9; San Diego, CA. Controversies in Neurology Plenary Session.

Editor’s Note: Charles has disclosed that he has received personal compensation for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer, Lundbeck, Abbvie, Amgen, and Vectura. The institution of Charles has received research support from NIH. He also noted that he has received publishing royalties from a publication relating to health care and has a noncompensated relationship as an Executive Board Member with American Headache Society that is relevant to AAN interests or activities.

The director of the UCLA Goldberg Migraine Program discussed the advantages, evidence base, and evolving payor support for CGRP-targeting therapies as potentially a first-line option in migraine prevention. [WATCH TIME: 5 minutes]

The associate professor in pain management and emergency medicine at UC San Diego shared her reaction to the FDA approval of suzetrigine, a selective, nonaddictive alternative to opioids for acute pain management. 

A Shared Perspective on the Newly Approved Nonopioid Alternative for Acute Pain: Jessica Oswald, MD, MPH

“[Suzetrigine] redefines a standard of care about providing nonopioid pain relief with fewer [adverse] effects. There are potential future applications in chronic pain, although more research is needed.”

Acute pain, often resulting from surgery, accidents, injuries, or from neurologic conditions, is known as a significant and potentially debilitating condition. Each year, over 80 million patients in the United States receive prescriptions for moderate-to-severe acute pain, with nearly 40 million being prescribed opioids. However, opioid use for acute pain carries risks, as around 10% of patients initially treated with opioids develop prolonged use, and approximately 85,000 individuals annually are diagnosed with opioid use disorder. Beyond individual consequences, poorly managed acute pain can lead to chronic pain, reduced quality of life, and increased strain on the healthcare system.

 (Journavx; Vertex Pharmaceuticals) for the treatment of moderate-to-severe acute pain, making it the first new drug class for acute pain in over 2 decades. This approval was supported by a phase 3 clinical program that included 2 randomized, double-blind, placebo-controlled trials—one in post-abdominoplasty surgery and another in post-bunionectomy surgery—as well as a broader safety and efficacy study involving both surgical and non-surgical pain conditions. By targeting only peripheral pain signals without affecting the brain, suzetrigine provides effective pain relief while avoiding the addictive potential and adverse effects associated with opioids.

Following the approval, Jessica Oswald, MD, MPH, an associate professor in pain management and emergency medicine at UC San Diego, shared her insights and initial reaction in a recent interview with 

. During the discussion, Oswald, also a steering committee member at Vertex, addressed key questions regarding suzetrigine’s place in the pain management landscape, including how it compared with traditional opioid treatments in terms of efficacy and safety across different patient populations. She also explored the potential impact of suzetrigine’s availability on perioperative and emergency pain management strategies. Additionally, Oswald delved into the broader implications of NaV inhibitors, such as suzetrigine, on the future of chronic pain treatment and ongoing research in the field.

REFERENCES
1. Vertex Announces FDA Approval of JOURNAVX™ (suzetrigine), a First-in-Class Treatment for Adults With Moderate-to-Severe Acute Pain. News Release. Published January 30, 2025. Accessed February 21, 2025. https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-fda-approval-journavxtm-suzetrigine-first-class
2. Vertex Announces FDA Acceptance of New Drug Application for Suzetrigine for the Treatment of Moderate-to-Severe Acute Pain. News Release. Vertex. July 30, 2024. Accessed February 21, 2025. https://news.vrtx.com/news-releases/news-release-details/vertex-announces-fda-acceptance-new-drug-application-suzetrigine

The associate professor in pain management and emergency medicine at UC San Diego shared her reaction to the FDA approval of suzetrigine, a selective, nonaddictive alternative to opioids for acute pain management. [WATCH TIME: 4 minutes]

The professor of neurology at the Geisel School of Medicine at Dartmouth talked about how the combination therapy involving meloxicam and rizatriptan may provide a more effective approach to treating migraine. 

The Rationale Behind Recently Approved AXS-07 Combination Therapy for Migraine: Stewart Tepper, MD

"What we're really after clinically is ‘one and done.’ We want to treat and have [the patient] pain-free in 2 hours, without significant [adverse] effects most of the time, and without a recurrence of the headache.”

Combination therapies in migraine management involve using 2 or more treatments, either acute or preventive, together to address different aspects of the migraine process. Common acute treatments, such as nonsteroidal anti-inflammatory drugs and triptans, target distinct mechanisms in the inflammatory and neural pathways of migraines. When used together, these treatments provide incremental benefits. For instance, the combination of sumatriptan and naproxen sodium has proven effective in treating migraines. Other fixed combinations include acetaminophen/aspirin/caffeine and combinations containing butalbital.

Research supports the efficacy of combination therapy, with 62% of studies showing improved outcomes compared with monotherapy. Additionally, 90% of studies reported no significant increase in adverse effects, suggesting that combination therapies can enhance efficacy without compromising tolerability. However, some studies did not demonstrate superior benefits, underlining the need for further research to identify which drug combinations are most effective.

 (Symbravo; Axsome Therapeutics), a combination therapy of meloxicam and rizatriptan, highlighted the potential for tailored, effective migraine treatment, offering a new option for adults with migraine with or without aura.

, a professor of neurology at the Geisel School of Medicine at Dartmouth, sat down in a recent interview with 

to further share his perspective on the approval. Tepper, who also serves as the vice president of the New England Institute for Neurology and Headache, talked about how this newly approved combination therapy may improve outcomes compared with monotherapy medications on their own.In the conversation, he also spoke about the challenges healthcare providers may face in ensuring patients follow combination therapy protocols. In addition, he spoke on how pharmacokinetic properties of new formulations like AXS-07 might contribute to more rapid and sustained migraine relief.

REFERENCES
1. Pellesi L, Garcia-Azorin D, Rubio-Beltrán E, et al. Combining treatments for migraine prophylaxis: the state-of-the-art. J Headache Pain. 2024;25(1):214. Published 2024 Dec 5. doi:10.1186/s10194-024-01925-w
2. Lipton RB, Ailani J, Blumenfeld AM. What Is Combination Treatment in Migraine? Moving Toward a Uniform Definition of a Familiar Principle. Neurol Ther. 2024;13(6):1535-1540. doi:10.1007/s40120-024-00669-8
3. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. News Release. Axsome Therapeutics. Published January 30, 2025. Accessed February 4, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam

Editor’s note: Tepper has received advisory fees from numerous pharmaceutical and healthcare organizations, including AbbVie, Amgen, Axsome Therapeutics, Eli Lilly, Lundbeck, Novartis, Pfizer, Teva, and others. He has received honoraria for lectures and continuing medical education from institutions such as the American Academy of Neurology, the American Headache Society, Medscape, and multiple medical education providers. Additionally, he has received research funding from Aeon, AbbVie, Eli Lilly, Lundbeck, Neurolief, Pfizer, and Suven. Travel support has been provided by AbbVie, the American Headache Society, Diamond Headache Clinic, Eli Lilly, and Pfizer.

The professor of neurology at the Geisel School of Medicine at Dartmouth talked about how the combination therapy involving meloxicam and rizatriptan may provide a more effective approach to treating migraine. [WATCH TIME: 6 minutes]

The director of the Montefiore Headache Center at Albert Einstein College of Medicine provided an overview of the drug profile for the recently approved migraine treatment AXS-07.

Safety and Efficacy Considerations of Newly Approved Combination Therapy for Acute Migraine: Richard B. Lipton, MD

“In terms of use in clinical practice, we want to treat our patients with the simplest, most effective acute treatments available. So, you wouldn’t use a combination triptan–nonsteroidal product in a patient whose treatment needs were fully met by either a triptan alone or a nonsteroidal anti-inflammatory alone.”

Migraine is considered a debilitating neurological disorder marked by recurring episodes of intense, throbbing head pain, often accompanied by nausea and heightened sensitivity to light and sound. According to the American Migraine Foundation, more than 39 million Americans are impacted by this condition, making migraine the leading cause of disability among neurological conditions in the United States.

 Patient surveys have highlighted the significant demand for treatments that act more quickly, provide consistent relief, and reduce symptom recurrence. Notably, over 70% of patients have reported insufficient response to their current oral acute migraine therapies.

 (Symbravo; Axsome Therapeutics), a novel agent consisting of meloxicam and rizatriptan, as a new acute treatment of migraine with or without aura in adults. The approval was based on data from 2 phase 3 randomized controlled clinical trials—the MOMENTUM trial (NCT03896009) and the INTERCEPT trial (NCT04163185)—in which AXS-07 demonstrated a statistically significant elimination of migraine pain relative to placebo and active controls. Additionally, the most common adverse reactions in the controlled studies were somnolence and dizziness, being reported in 2% and 1% of patients in the AXS-07 and placebo arms, respectively.

, a professor of neurology and director of the Montefiore Headache Center at 

, discussed the role of combination therapy in acute migraine management. He highlighted how the combination of rizatriptan and meloxicam compared to other acute treatments in terms of efficacy and safety. Lipton also addressed the specific patient populations that may derive the most value from this approach, emphasizing the importance of selecting therapies based on individual treatment needs. Additionally, he underscored the critical role of timing in migraine treatment, explaining that early intervention can significantly improve treatment outcomes and overall patient response.

REFERENCES
1. Ashina M, Katsarava Z, Do TP, et al. Migraine: epidemiology and systems of care. Lancet. 2021;397(10283):1485-1495. doi:10.1016/S0140-6736(20)32160-7
2. Lipton RB, Munjal S, Buse DC, et al. Unmet Acute Treatment Needs From the 2017 Migraine in America Symptoms and Treatment Study. Headache. 2019;59(8):1310-1323. doi:10.1111/head.13588
3. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. News Release. Axsome Therapeutics. Published January 30, 2025. Accessed February 3, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam
4. Axsome Therapeutics Announces AXS-07 Achieves Co-Primary and Key Secondary Endpoints in MOMENTUM Phase 3 Migraine Trial in Patients with History of Inadequate Response. News release. Axsome Therapeutics. December 30, 2019. Accessed February 3, 2025. https://www.biospace.com/article/releases/axsome-therapeutics-announces-axs-07-achieves-co-primary-and-key-secondary-endpoints-in-momentum-phase-3-migraine-trial-in-patients-with-history-of-inadequate-response
5. Axsome Therapeutics announces AXS-07 achieves both co-primary endpoints and prevents migraine pain progression in the INTERCEPT phase 3 trial in the early treatment of migraine. news release. Axsome Therapeutics. April 6, 2020. Accessed February 3, 2025. https://www.finance.yahoo.com/news/axsome-therapeutics-announces-axs-07-100010869.html

The director of the Montefiore Headache Center at Albert Einstein College of Medicine provided an overview of the drug profile for the recently approved migraine treatment AXS-07. [WATCH TIME: 3 minutes] 

The professor of neurology at the Geisel School of Medicine at Dartmouth shared his reaction to the recent FDA approval of AXS-07, a combination of meloxicam and rizatriptan, as a new therapy for acute migraine management.  

Medical Insights on the Recent Approval of AXS-07 for Acute Migraine Treatment: Stewart Tepper, MD

“The hope is that as we educate practitioners, the understanding of why combining an [nonsteroidal anti-inflammatory drug] with a triptan should provide additional benefit in the acute treatment of migraine for patients will become more and more clear, and that is my hope for the future."

Migraine is a debilitating neurological disorder marked by recurrent episodes of pulsating head pain, often accompanied by nausea and sensitivity to light and sound. Current acute treatments remain suboptimal, with over 70% of patients expressing dissatisfaction because of slow or inconsistent pain relief and pain recurrence.

 Studies show poor acute treatment has been linked to an increased risk of chronic migraine, which may be mitigated by improving treatment outcomes. In addition, predictors of poor response have included allodynia, severe migraine pain, obesity, and morning migraines. Thus, there is an urgent need for new acute therapies that offer faster, more consistent, and sustained relief for this serious condition.

AXS-07 (Axsome Therapeutics), a novel combination therapy, aims to address the limitations of current acute migraine treatments by leveraging multiple mechanisms of action. It consists of MoSEIC (Molecular Solubility Enhanced Inclusion Complex) meloxicam, a rapidly absorbed COX-2 preferential nonsteroidal anti-inflammatory drug (NSAID), and rizatriptan, a potent 5-HT1B/1D agonist known for its fast-acting efficacy in migraine relief. The proprietary MoSEIC delivery technology is designed to enhance meloxicam’s solubility and absorption while extending its plasma half-life. By combining these agents, AXS-07 offers a pharmacokinetic profile that may lead to more effective and sustained migraine management.

, marketed as Symbravo, as a new acute treatment for migraine with or without aura in adults, with supportive data from 2 phase 3 randomized controlled clinical trials—the MOMENTUM trial (NCT03896009) and the INTERCEPT trial (NCT04163185).

, a professor of neurology at the Geisel School of Medicine at Dartmouth and vice president of the New England Institute for Neurology and Headache, shared his reaction in a recent interview with 

In the conversation, Tepper discussed the benefits of combining an NSAID with a triptan for acute migraine, highlighting its enhanced efficacy over monotherapy. He also examined trial designs assessing real-world effectiveness of AXS-07 and emphasized the need for better provider education as well as patient access to this treatment.

REFERENCES
1. Smelt AF, Louter MA, Kies DA, et al. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014;9(6):e98933. Published 2014 Jun 16. doi:10.1371/journal.pone.0098933
2. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. News Release. Axsome Therapeutics. Published January 30, 2025. Accessed February 4, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam

The professor of neurology at the Geisel School of Medicine at Dartmouth shared his reaction to the recent FDA approval of AXS-07, a combination of meloxicam and rizatriptan, as a new therapy for acute migraine management.  [WATCH TIME: 4 minutes]

Migraine

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