Multidisciplinary Association for Psychedelic Studies (MAPS) has received US Food and Drug Administration (FDA) approval to expand access to 3,4-methylenedioxy-methamphetamine (MDMA)-based psychotherapy for post-traumatic stress disorder (PTSD).
Non-profit organisation MAPS will conduct the Expanded Access programme for patients who did not achieve an adequate response to existing treatments or cannot enrol in Phase III clinical trials.
In December, MAPS secured FDA approval for its Expanded Access protocol involving MDMA-assisted psychotherapy for 50 PTSD patients.
The latest authorisation from the US regulator is intended to enable an increase in the number of participants based on data from an initial 35 patients in the Expanded Access programme, which will enrol at up to ten sites in the US.
During the new programme, MAPS will recruit only treatment-resistant patients with moderate to severe PTSD. The programme will not include a control group.
MAPS founder and executive director Rick Doblin said: “We commend FDA for recognising the great unmet medical need of PTSD by allowing access to MDMA-assisted psychotherapy on a compassionate basis for people with treatment-resistant PTSD.
“We are delighted to begin generating real-world evidence about this potential new treatment.”
Patients undergoing MDMA-assisted psychotherapy will receive up to three MDMA administrations in combination with psychotherapy in a controlled clinical environment.
MAPS’ Expanded Access protocol for this treatment approach is yet to obtain approvals from the US Drug Enforcement Administration (DEA) and Institutional Review Board (IRB).
In February last year, the Israeli Ministry of Health approved Compassionate Use of MDMA-assisted psychotherapy for 50 PTSD patients at four sites across the country.
MAPS is currently funding Phase III studies of MDMA-based psychotherapy to treat PTSD at 15 sites in the US, Canada and Israel. These trials are set to be completed next year.
The organisation will also launch a Phase II trial in Europe this month.