FDA Approves Symbravo for Acute Treatment of Migraine With or Without Aura

The FDA approved meloxicam and rizatriptan (Symbravo; Axsome Therapeutics Inc.) for the acute treatment of migraine, either with or without aura. The treatment has been shown to reduce migraine pain and help patients return to normal functioning with efficacy through 24 to 48 hours after a single dose for some patients.¹

The FDA approved meloxicam and rizatriptan (Symbravo; Axsome Therapeutics Inc) for the acute treatment of migraine, either with or without aura | Image Credit: goodluz | stock.adobe.com

“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 the Albert Einstein College of Medicine, said in a news release. “Results of multiple clinical trials demonstrate that [Symbravo] can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild or later in the attack when the pain may be severe. The approval of [Symbravo] is a long-awaited and much welcomed advancement for clinicians and our patients, providing a new, meaningful treatment option.”¹

Meloxicam and rizatriptan showed a broad range of efficacy, including at the earliest onset of migraine when the pain was mild, for patients with moderate to severe migraine pain, and for those who had a history of various responses to acute treatment. The approval is based on the phase 3 MOMENTUM trial, the phase 3 INTERCEPT trial, and the phase 3 MOVEMENT trial. The MOMENTUM trial included migraine pain that was moderate to severe intensity, INTERCEPT included initial pain that was mild, and MOVEMENT was the long-term safety trial.¹

The MOMENTUM trial included 1594 individuals who were treated with meloxicam and rizatriptan, the placebo, meloxicam alone, or rizatriptan alone. A greater percentage of patients achieved pain freedom with the use of meloxicam and rizatriptan compared with the placebo at 19.9% and 6.7%, respectively, as well as the most bothersome symptom (36.9% and 24.4%, respectively) at 2 hours. Meloxicam and rizatriptan also demonstrated faster median time to pain relief at 1.5 hours compared with the placebo at 12 hours, meloxicam at 4 hours, and rizatriptan at 3 hours. Furthermore, a greater proportion of individuals had sustained pain freedom and pain relief at 48 hours when using meloxicam and rizatriptan compared with either other treatment group.²

In the INTECERPT trial, investigators included 302 patients who received either meloxicam and rizatriptan or the placebo when pain was mild. The 2-hour post-dose pain freedom was 32.6% compared with the placebo at 16.3%, and freedom from the most bothersome symptom was 43.9% and 26.7%, respectively. Meloxicam and rizatriptan also prevented pain progression at 73.5% compared with 47.4% for the placebo, with 15.3% of individuals in the meloxicam and rizatriptan group and 42.2% in the placebo group using rescue medication through 24 hours.³

Finally, in the open-label study, 706 individuals were enrolled, and 39% and 68% experienced pain relief 1 hour and 2 hours post-dose, respectively. Pain freedom and absence of the most bothersome symptom were 38% and 47%, respectively, for 2 hours after the first dose. Sustained pain relief from 2 to 24 hours and 2 to 48 hours was approximately 60% and 59%, respectively, with pain freedom being 33% and 32%, respectively. Further, 85% of patients remained free of using their rescue medication through 24 hours and 83% through 48 hours. The long-term safety showed intermittent dosing up to 12 months to treat at least 2 migraine attacks per month, according to the news release.^1,4

The most common adverse reactions were somnolence and dizziness, which were comparable for the treatment and placebo arm.¹

“Migraine is one of the most misunderstood and stigmatized neurological diseases, despite the fact that 1 in 4 households in the US includes someone living with it. This widespread lack of understanding creates unnecessary barriers for individuals seeking proper diagnosis, care, and treatment,” Susan Doughty, executive director of the Coalition for Headache and Migraine Patients, said in the new release. “The approval of [Symbravo] as a new acute treatment for migraine is an important step forward, offering a new option for people seeking relief.”¹

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. Axsome Therapeutics. January 30, 2025. Accessed January 30, 2025. https://www.globenewswire.com/news-release/2025/01/30/3018389/33090/en/Axsome-Therapeutics-Announces-FDA-Approval-of-SYMBRAVO-meloxicam-and-rizatriptan-for-the-Acute-Treatment-of-Migraine-with-or-without-Aura-in-Adults.html

2. Jones A, Tepper S, Lipton R, Tabuteau H. Efficacy and Safety of AXS-07 (MoSEIC Meloxicam-Rizatriptan) for the Acute Treatment of Migraine: Results from the MOMENTUM Phase 3, Randomized, Double-blind, Active- and Placebo-controlled Trial (P13-2.005). 2022 May 2. doi:https://doi.org/10.1212/WNL.98.18_supplement.3564.

3. Jones A, Tepper S, Lipton R, Tabuteau H. Efficacy and Safety of AXS-07 (MoSEIC Meloxicam-Rizatriptan) for the Acute Treatment of Migraine: Results from the INTERCEPT Phase 3, Randomized, Double-blind, Placebo-controlled Trial (P14-2.004). 2022 May 3. doi:https://doi.org/10.1212/WNL.98.18_supplement.1112.

4. 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.