At Acadia, we are passionate about improving the lives of patients and their caregivers by developing and commercializing innovative medicines to address unmet needs in central nervous system disorders. Acadia is committed to bringing safe and effective treatments to patients by conducting rigorous clinical trials and obtaining approval for marketing by regulatory agencies. Before new treatments can be broadly available, the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world require that investigational medicine(s) are studied in clinical trials.
Acadia does not have an expanded access program that offers patients access to our investigational therapies outside of clinical trials or prior to FDA approval. Acadia believes clinical trials are the most appropriate way for patients to access investigational medicines developed by Acadia. In these trials, the safety and efficacy of investigational medicines is rigorously assessed by Acadia and the relevant regulatory agencies in order to understand the medicine’s benefits, risks, and appropriate use, including whether or not it should be approved as a therapy for its intended use. Obtaining regulatory approval is the best way to bring safe and effective medicines to the greatest number of patients who may benefit from treatment.