FDA puts MDMA therapy for PTSD on its Expanded Access program

pharmafile | January 24, 2020 | News story | Medical Communications Expanded Access, MAPS, MDMA, PTSD, pharmaceuticals, psychedelics, war 

The FDA has made MDMA treatment for PTSD more accessible by putting it on the Expanded Access program.

10 sites across the US will receive approval to administer the drug under a doctor’s supervision, but only 50 patients will be enrolled in the scheme. Multidisciplinary Association for Psychedelic Studies (MAPS) plans to submit the patient data to the FDA so the agency can decide on whether to broaden the program.

The Expanded Access program, also known as compassionate use, allows patients with serious or life-threatening conditions who cannot participate in clinical trials to try experimental drugs. In 2017, the FDA gave priority review to Multidisciplinary MAPS’s MDMA therapy due to promising trial results.

Surviving traumatic experiences can create neurobiological changes in the brain that provoke uncontrollable nightmares and flashbacks, especially after triggers reminiscent of the traumatic event. MDMA helps treat patients with PTSD by giving them a brief reprieve from the symptoms which allows them to effectively process difficult memories related to the conditions.

MAPS founder and Executive Director Rick Doblin said in a statement: “We commend FDA for recognizing 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.”

Conor Kavanagh

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