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

WATCH TIME: 3 minutes

“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.¹ 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.²

In recent news, the FDA approved AXS-07 (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.^4,5

In a recent interview with NeurologyLive^®, Richard B. Lipton, MD, a professor of neurology and director of the Montefiore Headache Center at Albert Einstein College of Medicine, 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