Expanded Access for MDMA-Assisted Therapy
An expanded access program allows pharmaceutical companies, in limited circumstances, to provide patients with an investigational medical product not yet approved by the U.S. Food and Drug Administration (FDA) for treatment outside of a clinical trial. The program is intended for patients with serious or life-threatening conditions when no comparable or satisfactory alternative therapy options are available and who are ineligible or unable to participate in ongoing clinical trials.
MAPS PBC received FDA authorization to establish an expanded access program for MDMA-assisted therapy for up to 50 patients with post-traumatic stress disorder (PTSD) who met specific eligibility criteria. That program has been fully enrolled and is no longer accepting applications.
We appreciate the urgent need for new and effective treatments for PTSD and are focused on pursuing FDA approval for MDMA-assisted therapy to help make it more widely available to people with PTSD.