Overview
- The FDA cleared Auvelity for Alzheimer’s‑related agitation on Thursday, making it the first approved option that is not an antipsychotic.
- Regulators leaned on ACCORD‑2, a randomized‑withdrawal study that cut relapse risk versus placebo, with 8.4% relapsing on drug versus 28.6% on placebo.
- Short‑term efficacy was mixed, with ADVANCE‑1 meeting its week‑5 goal on the Cohen‑Mansfield Agitation Inventory and ADVANCE‑2 missing its primary endpoint.
- The label lists dizziness and stomach upset as common side effects and warns about suicidality in adolescents and young adults, seizure risk, and increased blood pressure, prompting close monitoring.
- Axsome plans a June U.S. launch at a $1,248 monthly list price, promising a new option for the many families coping with agitation that affects roughly half to three‑quarters of people with Alzheimer’s.