Axsome Therapeutics (AXSM) FDA announcement summary

Introduction and purpose

• FDA approved AUVELITY (dextromethorphan HBr and bupropion HCl) for agitation associated with dementia due to Alzheimer's disease, marking a significant milestone for patients, caregivers, and neuropsychiatric care.

• AUVELITY is the first FDA-approved treatment for this indication, targeting NMDA and sigma-1 receptors.

• The mission is to deliver transformative medicines to improve brain health for millions.

Details of approval or decision

• AUVELITY is now approved as the first-in-class treatment for agitation in Alzheimer's disease, following Breakthrough Therapy designation and Priority Review.

• The new indication is for agitation associated with dementia due to Alzheimer's disease; not for as-needed use.

• AUVELITY is also approved for major depressive disorder in adults.

Impact on industry and stakeholders

• Over 7 million Americans are affected by Alzheimer's agitation, with a significant unmet need for effective treatments.

• AUVELITY is the only approved treatment demonstrating substantial symptom improvement and longer time to relapse.

• Broad insurance coverage is in place, with 100% Medicare/Medicaid and 78% commercial lives covered.

• Comprehensive patient support programs, including savings cards and prior authorization support, will be available at launch.

• Caregiver surveys highlight the burden of agitation and the positive impact of symptom control, with expected reduction in caregiver burden and delayed institutionalization.