An Intermediate-size Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD
Expanded access is a program that allows patients to receive an investigational treatment not yet approved by the United States Food and Drug Administration (FDA) for treatment outside of a clinical trial. The program is intended for patients with serious or life-threatening conditions who do not have any promising treatment options and are unable to participate in ongoing clinical trials. Only sites within the U.S and U.S territories are eligible to participate in the FDA Expanded Access Program.
The rationale for our expanded access program is to treat more patients with MDMA-assisted therapy, but also to understand logistics of how of MDMA-assisted therapy will be administered post-approval by generating real world evidence (RWE).
Clinical Trial Information
Clinical trials are the most common and preferred way for patients to gain access to an investigational treatment. Clinical trials are used to determine whether a new treatment is safe and effective. Information from clinical trials may lead to a new approved treatment, which can make a treatment more widely available to patients.
For information about MAPS-sponsored clinical trials, visit maps.org/research.
Who is eligible for expanded access?
MAPS has obtained sufficient clinical information about MDMA-assisted therapy to identify a population of patients for whom expanded access may be appropriate. MAPS has received FDA authorization to establish an expanded access program for a limited group of patients who meet specific eligibility criteria. This program is managed by MAPS Public Benefit Corporation (MAPS PBC) and follows a specific protocol, which is developed in consultation with the FDA for the use of the investigational treatment.
To be eligible for access to an investigational treatment, the following criteria will be used to evaluate requests for individual patients and must be met:
- The patient has a serious or immediately life-threatening disease or condition.
- The patient has undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available to treat the disease or condition.
- The patient is not eligible for participation in any ongoing MAPS-sponsored clinical trial of the investigational treatment and indication, including lack of access due to geographic limitations.
- The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational treatment and the potential benefit outweighs the known anticipated risk.
- The patient meets any other pertinent medical criteria for access to the investigational treatment, as established by the protocol.
The current FDA authorization for the expanded access of MDMA-assisted therapy limits the availability of this investigational treatment such that treatment is not guaranteed to all patients who meet these criteria.
To learn more about active expanded access sites, visit clinicaltrials.gov.
How to request Expanded Access Treatment?
We encourage patients to speak first with their physician or therapist about their eligibility to enroll in an ongoing clinical trial.
If a treating physician believes MDMA-assisted therapy may be the only option for a patient with PTSD, the physician should contact an expanded access site to make a formal request on behalf of the patient. This will enable the physician to work with the expanded access site to determine the best course of action.
The request for access to MDMA-assisted therapy can only be considered if the patient’s treating physician or therapist is committed to, and supportive of, the requested treatment.
The sponsor and manufacturer (MAPS) is providing expanded access treatment solely through the established treatment protocol at expanded access sites. In the U.S., physicians seeking help on behalf of their patients may contact expanded access sites listed on clinicaltrials.gov. Outside of the U.S., MAPS is currently not able to offer an expanded access program at this time. Once expanded access sites have received the request and required medical information, receipt of requests will be acknowledged within 10 business days.
Submission of a request for expanded access is not a guarantee of access to any specific investigational treatment.
