Drug Development Overview
Background
Patients with Alzheimer’s disease (AD) often face challenging neuropsychiatric symptoms, like agitation. This can lead to increased stress for caregivers and more placements in long-term care facilities. AXS-05, a new drug combining dextromethorphan and bupropion, is being studied for treating AD agitation (ADA). It is already FDA-approved for major depressive disorder.
Study Details
Two major studies were conducted: Phase 2 ADVANCE-1 and Phase 3 ACCORD. Both studies focused on patients aged 65-90 with probable AD.
ADVANCE-1 Study
This study looked at how AXS-05 affects ADA over 5 weeks. Patients were divided into three groups: AXS-05, bupropion, or placebo.
- Primary Endpoint: Change in agitation scores (Cohen-Mansfield Agitation Inventory – CMAI).
- Results: AXS-05 significantly reduced agitation scores compared to both bupropion and placebo.
- Common Side Effects: Somnolence (8.2%), dizziness (6.3%), diarrhea (4.4%).
ACCORD Study
This study measured how well AXS-05 prevents ADA relapse over a longer period.
- Primary Endpoint: Time until relapse.
- Results: AXS-05 increased time-to-relapse and had lower relapse rates compared to placebo.
- Common Side Effects: Dizziness (9.6%), diarrhea (4.5%), falls (5.1%).
Conclusion
AXS-05 showed a significant reduction in ADA symptoms after 5 weeks and increased time before relapse. It was well tolerated, making it a promising treatment option for ADA.
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