Expanded Access Policy
Vistagen Therapeutics is a clinical-stage biopharmaceutical company committed to developing and commercializing new generation medicines that go beyond the current standard of care for anxiety, depression and other central nervous system (CNS) disorders.
Participation in clinical trials is critical to the development of new medicines and patients entering clinical trials are required to meet specific criteria. We believe that clinical trials are the most appropriate way for patients to access the investigational medicines that we are developing.
In our clinical trials, the safety and efficacy of each of our drug candidates are rigorously assessed by both our team of experts and relevant regulatory agencies to understand the medicine’s benefits, risks, and appropriate use(s), including whether or not it should be approved as a therapy for its intended use(s). Obtaining regulatory approval is the best way ensure that development of safe and effective medicines is proceeding as quickly as possible to permit the widest possible distribution of our products to the greatest number of patients who may benefit from treatment.
For those patients who do not meet the criteria, or if a clinical trial is not available, expanded access (sometimes called compassionate use) may be a path for patients to receive our investigational medicines. However, given the current stage of development of our investigational drug candidates, Vistagen does not yet have an expanded access or compassionate use program that offers patients access to our drug candidates outside of clinical trials or prior to FDA approval.