The United States FDA has granted approval for the treatment for Expanded Access, enabling specific patients admittance to the therapy prior to the full market approval. This is a notable conquest in the advancement of MDMA-assisted psychotherapy for post-traumatic stress disorder.
According to reports, 10 U.S.-based clinics are ready to begin the therapy’s administration. Phase 3 trials are presently taking place, whereas complete approval is expected in 2022.
It takes a new pharmaceutical treatment considerable time to make its way from initial discovery to market approval. The human clinical trials process may take between 5 and 7 years, with the assumption that everything else goes by smoothly. The Multidisciplinary Association for Psychedelic Studies, a non-profit establishment, has been trying for many decades now to construct MDMA-assisted psychotherapy for post-traumatic stress disorder.
Through the Expanded Access program of the FDA, patients with severe ailments are allowed access to treatments undergoing the processes of clinical inspection. Expanded Access is often referred to as the compassionate use program. It grants patients conditional admittance to particular treatments.
Presently, the MDMA-assisted psychotherapy for post-traumatic stress disorder is undergoing Phase 3 clinical trials. Even though market approval is a good 2 to 3 years away, FDA has now granted Expanded Access to the treatment.
The Multidisciplinary Association for Psychedelic Studies has publicized 10 treatment sites based in the U.S. which will launch Expanded Access administration of the treatment. The Expanded Access approval granted by the FDA is a little more restricted compared to the wider application being tested for, hence, pre-approval administration will be applied only to patients resistant to treatment having moderate to strong treatment-resistant post-traumatic stress disorder.
MAPS also stated how 120 clinics have applied to begin MDMA therapy under the conditions of Expanded Access.