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 non-antipsychotic and first-in-class treatment approved 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 received FDA Breakthrough Therapy designation and Priority Review for agitation in Alzheimer's disease.

• Approval is based on efficacy and safety data from the ADVANCE-1 and ACCORD-2 clinical trials.

• The new label for AUVELITY includes no new box warning for elderly patients; existing boxed warning for suicidal thoughts in young patients.

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

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

Impact on industry and stakeholders

• Over 5 million people in the U.S. are affected by Alzheimer's agitation, with numbers expected to double in coming decades; some estimates cite over 7 million Americans.

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

• Strong insurance coverage: 100% of Medicare/Medicaid and 78% of commercial lives covered.

• Launch preparations are nearly complete, with full commercial launch planned for June and comprehensive patient support programs available at launch.

• Expected to reduce caregiver burden and delay institutionalization.