FDA Approves Axsome Therapeutics’ Symbravo for Migraine with or without Aura

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The FDA has approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan), a novel acute treatment for adults with migraine with or without aura. According to the company, Symbravo employs Axsome’s MoSEIC rapid absorption technology to enhance meloxicam’s bioavailability while combining it with rizatriptan. Data from the Phase III MOMENTUM, INTERCEPT, and MOVEMENT trials showed Symbravo produced statistically significant pain freedom and symptom relief at two hours post-dose, with sustained benefits compared to placebo and rizatriptan alone.¹

“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. 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,” said Richard B. Lipton, MD, professor of neurology, director, Montefiore Headache Center, Albert Einstein College of Medicine, in a press release.

Results from the MOMENTUM trial found that found that Symbravo demonstrated statistically significant efficacy over placebo. Additionally, 77% of patients didn’t require rescue medication within 24 hours post dose. A head-to-head comparison with rizatriptan further highlighted Symbravo’s superiority in sustained pain freedom from two to 24 hours, with benefits observed after a single dose.

Data from the INTERCEPT trial demonstrated results similar to those of the MOMENTUM trial in patients experiencing photophobia, phonophobia, and nausea two hours after dosing. Eighty-five percent of patients in the trial did not require rescue medication within 24 hours post dose.

The long-term open label MOVEMENT safety trial consisted of 706 patients to determine the long-term safety of Symbravo. Common adverse events included somnolence and dizziness.¹

According to a study published in the JAMA Network, approximately 10% of the global population can experience migraines. Additionally, migraines are most prevalent in people between 20 and 50 years of age. Further, it is three times more common in women than in men.² According to the World Health Organization (WHO), children usually experience shorter migraines than adults, although abdominal symptoms are more common.

WHO estimates that headache disorders as a whole affect approximately 40% of the global population. Additionally, headaches are the third highest cause of disability-adjusted life years globally, behind only stroke and dementia. It is among the three most common neurological conditions in most age groups between five and 80 years of age. Other common forms of headache include tension-type headache, cluster headache, and medication-overuse headache.³

“Today’s approval of Symbravo marks an important milestone for the migraine community by providing a rationally designed novel acute treatment for this debilitating condition. Migraine attacks strike without warning and disrupt the lives of estimated more than 39 million patients in the US alone. Symbravo provides patients and clinicians an important new option which can quickly stop a migraine attack, keep it away, and allow patients to resume their normal activities, with just a single dose. Symbravo demonstrates Axsome’s commitment to developing and delivering differentiated new treatments to improve the lives of patients living with difficult to treat central nervous system disorders,” said Herriot Tabuteau, MD, CEO, Axsome Therapeutics, in the press release.

References

1. Axsome Therapeutics Announces FDA Approval of SYMBRAVO® (meloxicam and rizatriptan) for the Acute Treatment of Migraine with or without Aura in Adults. Axsome Therapeutics. 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. What Is Migraine? JAMA. Accessed January 31, 2025. https://jamanetwork.com/journals/jama/fullarticle/2787727#:~:text=Migraine%20affects%20an%20estimated%20more,Are%20Episodic%20and%20Chronic%20Migraine?

3. Migraine and other headache disorders. WHO. March 6, 2024. Accessed January 31, 2025. https://www.who.int/news-room/fact-sheets/detail/headache-disorders