Axsome Says Symbravo Hits Primary Goal In Late-Stage Migraine Trial In Patients Experiencing Inadequate Response To Commonly Used Drugs

On Monday, Axsome Therapeutics, Inc. AXSM announced that the EMERGE Phase 3 trial of Symbravo (MoSEIC meloxicam and rizatriptan) in patients experiencing inadequate response to oral CGRP inhibitors (most commonly used drugs for migraine) met its primary endpoint.

Symbravo demonstrated statistically significantly greater migraine treatment response than oral CGRP inhibitors, as measured by the Migraine Treatment Optimization Questionnaire (mTOQ-4) (5.2 versus 2.8, p<0.001).

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In the trial, Symbravo rapidly and substantially improved migraine pain and most bothersome symptoms.

Statistically significantly greater proportions of patients achieved clinical response on the 2-hour pain freedom, sustained pain freedom, ability to return to normal activities, and ability to plan daily activities mTOQ-4 items with Symbravo compared to oral CGRP inhibitors:

• Pain freedom within 2 hours for most attacks was reported half the time or more by 47.9% of patients after treatment with Symbravo, compared to 1.0% of patients after treatment with oral CGRPs.
• Sustained relief of migraine pain for at least 24 hours following a single dose of medication was reported half the time or more by 47.9% of patients after treatment with Symbravo, compared to 16.7% of patients after treatment with oral CGRPs.
• The ability to quickly return to normal activities after taking their medication was reported half the time or more by 51.0% of patients after treatment with Symbravo, compared to 11.5% of patients after treatment with oral CGRPs.
• The proportion of patients who reported being comfortable enough with their medication to be able to plan daily activities half the time or more was 63.5% after treatment with Symbravo, compared to 26.0% after treatment with oral CGRPs.

Price Action: AXSM stock is down 4.82% at $131.12 at last check Monday.

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