US Authorities Reject Approval of MDMA-Based PTSD Treatment
The US Food and Drug Administration (FDA) has rejected a treatment for post-traumatic stress disorder (PTSD) based on MDMA, commonly known as ecstasy, according to a statement from Lekos Therapeutics, the developer of the treatment.
The US federal agency responsible for regulating food and drugs indicated that it could not verify the validity of the treatment “based on the data provided so far,” urging the company to “conduct an additional phase III trial” to obtain data on the safety and efficacy of the treatment, according to the statement.
The treatment, containing MDMA, known for its illegal recreational use, has undergone several tests and was associated with therapy sessions.
US laws prohibit the use of MDMA in the United States, and its authorization for medical treatment would have represented a major shift in this regard.
Post-traumatic stress disorder occurs after a traumatic event and affects approximately 5% of Americans. People with this disorder are more likely to exhibit suicidal behavior and develop drug dependence.
