8-K: Axsome Therapeutics' SYMBRAVO Receives FDA Approval for Acute Migraine Treatment

Axsome Therapeutics announces FDA approval of SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults, offering a novel multi-mechanistic approach.

Summary

• Axsome Therapeutics has received FDA approval for SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.
• SYMBRAVO is a single-dose oral medication that combines meloxicam and rizatriptan to target multiple migraine pathways.
• Clinical trials demonstrated that SYMBRAVO provides rapid migraine pain freedom and return to normal functioning within 2 hours, with sustained efficacy through 24 and 48 hours in some patients.
• In the MOMENTUM trial, 77% of patients treated with SYMBRAVO did not require rescue medication within 24 hours post dose.
• In the INTERCEPT trial, 85% of patients treated with SYMBRAVO did not require rescue medication within 24 hours post dose.
• The company expects SYMBRAVO to be commercially available in the U.S. in approximately four months.
• The long-term safety of SYMBRAVO was demonstrated in the MOVEMENT trial, which assessed 706 patients dosing intermittently for up to 12 months and treating at least 2 migraines per month with SYMBRAVO.
• SYMBRAVO is protected by a robust patent estate extending out to at least 2040.

Sentiment

Score: 9

Explanation: The document is highly positive due to the FDA approval of SYMBRAVO, strong clinical trial results, and management's optimistic outlook. The sentiment is further boosted by the potential for commercial success and the unmet need in the migraine treatment market.

Positives

• FDA approval of SYMBRAVO provides a new treatment option for migraine sufferers.
• SYMBRAVO demonstrated superior efficacy across a broad range of migraine severity.
• The medication showed statistically significant superiority compared to rizatriptan on sustained pain freedom from 2 to 24 hours in a head-to-head comparison.
• Axsomes rapid absorption technology enables meloxicams use as a new molecular entity for the acute treatment of migraine.
• The long-term safety of SYMBRAVO was demonstrated in the MOVEMENT trial, which assessed 706 patients dosing intermittently for up to 12 months and treating at least 2 migraines per month with SYMBRAVO.

Negatives

• The most common adverse reactions (1% and greater than placebo) in the controlled studies were somnolence and dizziness, being reported each in 2% and 1% of patients in the SYMBRAVO and placebo arms, respectively.
• SYMBRAVO is not indicated for the preventative treatment of migraine or for the treatment of cluster headache.

Risks

• The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Companys Sunosi, Auvelity, and Symbravo products and the success of the Companys efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Companys ability to maintain and expand payer coverage; the success, timing and cost of the Companys ongoing clinical trials and anticipated clinical trials for the Companys current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Companys ability to fully fund the Companys disclosed clinical trials, which assumes no material changes to the Companys currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Companys ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (NDA) for any of the Companys current product candidates; the Companys ability to fund additional clinical trials to continue the advancement of the Companys product candidates; the timing of and the Companys ability to obtain and maintain U.S. Food and Drug Administration (FDA) or other regulatory authority approval of, or other action with respect to, the Companys product candidates, including statements regarding the timing of any NDA submission; the Companys ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Companys research and development programs and collaborations; the success of the Companys license agreements; the acceptance by the market of the Companys products and product candidates, if approved; the Companys anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Companys commercial launch of its other product candidates, if approved, and the potential impact on the Companys anticipated cash runway; the Companys ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Companys control.

Future Outlook

The Company expects SYMBRAVO to be commercially available in the U.S. in approximately four months.

Management Comments

• Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics, said, 'Todays approval of SYMBRAVO marks an important milestone for the migraine community by providing a rationally designed novel acute treatment for this debilitating condition.'

Industry Context

The approval of SYMBRAVO addresses a significant unmet need in migraine treatment, as over 70% of patients report experiencing an inadequate response to their oral, acute migraine treatment.

Comparison to Industry Standards

• SYMBRAVO's efficacy in providing rapid and sustained pain relief, as demonstrated in clinical trials, positions it as a potentially competitive option compared to existing triptan medications like rizatriptan and other acute migraine treatments.
• The incorporation of Axsomes MoSEIC technology for rapid absorption of meloxicam differentiates SYMBRAVO from other NSAID-based migraine treatments.

Stakeholder Impact

• Shareholders: Positive impact due to potential revenue generation and market expansion.
• Patients: Improved treatment option for acute migraine with rapid and sustained relief.
• Clinicians: New tool for managing migraine with a novel multi-mechanistic approach.

Next Steps

• Axsome will host a conference call and webcast on January 31, 2025, to discuss the approval of SYMBRAVO.
• The company expects SYMBRAVO to be commercially available in the U.S. in approximately four months.

Key Dates