Overview
- The approval creates the first FDA‑cleared option for Alzheimer’s agitation that is not an antipsychotic.
- Agitation affects most people with Alzheimer’s and often leads to faster decline, heavier caregiver burden, and earlier placement in long‑term care.
- Late‑stage studies found lower agitation scores by week 5 and longer time to relapse versus placebo in more than 1,000 participants.
- Dizziness and upset stomach were the most common side effects, and trial dropouts due to side effects were 1.3% in both the drug and placebo groups.
- Axsome plans a June launch at a $1,248 monthly list price in a market where Rexulti is the only rival and carries a boxed mortality warning.