We’re committed to finding solutions to meet the greatest needs of patients and families living with neurological and rare diseases by developing and commercializing innovative medicines. That means conducting rigorous clinical trials to get the best possible treatments to those who need them.
Our medicines undergo complex and rigorous testing in clinical trials, which helps researchers to determine if the treatments are safe and effective. To ensure this is the case, all medicines developed by Acadia must meet standards set by the U.S. Food and Drug Administration (FDA) and similar regulatory authorities worldwide before becoming widely available.
We believe that achieving diverse representation in our clinical trials is essential to developing and commercializing therapies to ensure that study outcomes can be more broadly applied to achieve healthcare equity in the general population. We believe that clinical trial design and the diversity of its participants should more closely reflect the incidence and prevalence of the communities impacted by the disease states and therapies under evaluation.
To increase representation among diverse and underrepresented communities and to effectively address unmet needs in CNS and rare diseases, where appropriate, we aim to:
We believe completing clinical research and partnering with regulatory authorities is the best approach to improve health outcomes for people with an illness or disease.
Additionally, we believe 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.
In cases where a clinical trial isn’t an option or in countries where regulatory approval is not being sought, local regulators or health authorities may allow us or our partners to provide a treating physician with an investigational drug for eligible patients pre-approval or based upon approval in another country. Such individual use of an investigational drug is often called "expanded access" or “compassionate use.” It’s important to remember that investigational drugs have generally not yet received regulatory approval; therefore, their potential risks and benefits are not yet established. Healthcare professionals, patients and caregivers should consider all possible benefits and risks when seeking expanded access to an investigational drug.
For inquiries, including questions related to our clinical research or expanded access, please contact Acadia at medicalinformation@acadia-pharm.com.
