On 21 April, at the 2026 American Academy of Neurology (AAN) meeting, during a poster session, Axsome Therapeutics presented results from its Phase III MOVEMENT (NCT04068051) trial for its acute migraine therapy Symbravo (meloxicam + rizatriptan) focused on patient-reported outcomes.
Symbravo was approved by the US Food and Drug Administration (FDA) in January 2025 for the treatment of acute migraine following positive results in two short-term Phase III trials (MOMENTUM: NCT03896009; INTERCEPT: NCT04163185) evaluating the immediate efficacy of the drug to achieve headache pain freedom two hours after dosing. The current market for acute migraine therapies is highly competitive, with seven approved triptans and their generics, as well as various formulations of dihydroergotamine mesylate, the newer gepants, and Eli Lilly’s Reyvow (lasmiditan) all competing within the same segment. Therefore, the positive long-term data presented provides an additional dimension to Symbravo’s efficacy, which will be important for Axsome Therapeutics when looking to establish its position in the market.
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In the open-label MOVEMENT trial, participants who had completed the MOMENTUM or INTERCEPT trials continued treatment with Symbravo for up to 12 months. Long-term use of Symbravo resulted in improvements in Migraine Disability Assessment (MIDAS) score at 12 months, with 45.1% of patients reaching a minimal clinically important difference (MCID) in MIDAS score, defined as a greater than 4.5-point change. At baseline the mean MIDAS score was 22.5, indicating severe disability, so the minimum improvement seen would reduce patient disability to moderate. Improvements in Headache-Impact Test (HIT-6) were also seen across the 12 months, with the percentage of participants reaching an MCID in HIT-6 score, defined as a greater than five-point change, increasing from 21.4% at Month 1 to 34.1% at Month 12.
The final patient-reported outcome that was assessed was the 14-item Migraine-Specific Quality of Life Questionnaire (MSQ), which consists of three sub-domains evaluating how migraine both limits and prevents daily social and work-related activities—role function-restrictive and role function-preventive—and assessing the emotions associated with migraine. Long-term use of Symbravo resulted in improvements across all three sub-domains and thus MSQ total scores at 12 months. The improvements were greatest in the role function-restrictive and role function-preventive sub-domains, with 57.8% and 60.7% of patients, respectively, reaching an MCID in score, defined as a greater than five-point change for both subdomains, at 12 months. For the emotional function sub-domain, only 39.3% of patients reached an MCID score, a greater than eight-point change, at 12 months.
Additional data insights on Symbravo
In addition to the patient-reported outcomes, the MOVEMENT trial also demonstrated that the safety profile of Symbravo over 12 months was consistent with what was seen in the short-term trials. In the trial, the rate of discontinuation due to treatment-emergent adverse events was only 1.8%, demonstrating that Symbravo is well tolerated by patients.
The triptans are well entrenched in the acute migraine market and are expected to remain as first-line therapies due to their wide generic availability and high physician familiarity; therefore, Symbravo is competing to be a key second-line treatment option. Key opinion leaders (KOLs) previously interviewed by GlobalData had mixed views on Symbravo, with several KOLs highlighting concerns over cost, especially given that fixed-dose combination (FDC) drugs tend to be expensive, yet both meloxicam and rizatriptan are available separately as generics.
The long-term data presented at AAN 2026 built on data from AAN 2025, where Axsome Therapeutics presented a meta-analysis showing greater efficacy of Symbravo in achieving pain freedom two hours after administration when indirectly compared to the gepants. Given that the gepants have demonstrated improvements in quality of life with long-term use, it is important that Symbravo has also been able to demonstrate positive long-term effects as it looks to compete with that drug class. Real-world evidence demonstrating sustained long-term benefit and cost-effectiveness will be important for cementing Symbravo’s position in the acute migraine market, supporting its price point, and convincing both physicians and payers that the FDC product justifies its premium.
