FDA Approves Meloxicam and Rizatriptan For Acute Treatment of Migraine

Meloxicam and rizatriptan (Symbravo) have been approved by the FDA for the acute treatment of migraine with or without aura in adult patients, Axsome Therapeutics announced in a release.¹ The company said it anticipates the therapy to be commercially available in the United States in approximately 4 months.

The approval of Symbravo was based on positive data from a phase 3 program that included 2 trials that evaluated the therapy’s efficacy and a long-term open label safety trial. In the trials, a single dose of Symbravo demonstrated a rapid elimination of migraine pain that was sustained through 24 and 48 hours in some patients. The therapy’s efficacy was also seen across a broad range of settings.

READ MORE: Ajovy Demonstrates Safety, Efficacy in Pediatric Migraines

“A significant proportion of migraine patients experience inadequate efficacy with currently available acute treatments, leading to even greater suffering, and an increased risk of worsening of migraine pain and attack frequency,” Richard B. Lipton, MD, professor of Neurology and director of the Montefiore Headache Center at Albert Einstein College of Medicine said in a release.^{1 “}The approval of Symbravo is a long awaited and much welcomed advancement for clinicians and our patients, providing a new, meaningful treatment option.”

MOMENTUM (NCT03896009) was a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled phase 3 trial. The study included 1594 patients who randomly received meloxicam and rizatriptan, meloxicam alone, rizatriptan alone, or placebo. Compared to placebo, patients treated with Symbravo demonstrated a statistically significantly greater percentage of achieving pain freedom and freedom from their most bothersome symptom after 2 hours. The benefits were sustained through 24 and 48 hours for many patients. Additionally, 77% of patients treated with Symbravo did not require rescue medication within 24 hours.

INTERCEPT (NCT04163185) was a randomized, double-blind, single-dose, placebo-controlled phase 3 trial. The study included 302 patients who received either meloxicam and rizatriptan or the placebo when pain was mild. Similarly to MOMENTUM, Symbravo demonstrated statistically significantly greater percentage of patients achieving pain freedom and freedom from their most bothersome symptom 2 hours after dosing. Of the patients treated with the therapy, 85% did not require rescue medication within 24 hours.

MOVEMENT (NCT04068051) was a multicenter, open-label, phase 3 trial that evaluated the long-term safety and efficacy of intermittent chronic dosing with Symbravo in patients with migraine attacks. The study included 706 patients who received the therapy for up to 12 months who treated at least 2 migraines per month. The study found that 39% and 68% of patients achieved pain relief within 1 and 2 hours, respectively. Additionally, 85% of patients did not require a rescue medication through 24 hours and 83% did not require it through 48 hours.²

“Migraine is a debilitating condition that affects millions of Americans,” Stewart Tepper, MD, clinical professor of Neurology at the Geisel School of Medicine at Dartmouth, said in a release.¹ “Unfortunately, many patients still struggle to find an option that effectively treats their attacks and is both safe and well tolerated, which creates a great need for new migraine medicines. Symbravo’s approval by the FDA provides a new medicine for physicians and patients that was designed to target key unmet needs in the migraine treatment space. The clinical data supporting its approval validates the additive benefit of Symbravo’s multi-mechanistic design and demonstrates its potential to make a meaningful difference for the migraine community.”

READ MORE: Headache and Migraine Resource Center

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References

1. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. News Release. January 30, 2025. Accessed January 31, 2025. https://axsometherapeuticsinc.gcs-web.com/news-releases/news-release-details/axsome-therapeutics-announces-fda-approval-symbravor-meloxicam

2. Jones A, Tabuteau H. Long-Term Efficacy and Safety of AXS-07 (MoSEIC Meloxicam-Rizatriptan) for the Acute Treatment of Migraine: Results from the MOVEMENT Phase 3 Trial (P11-2.003). 2022 May 3. doi: https://doi.org/10.1212/WNL.98.18_supplement.2915.