The Multidisciplinary Association for Psychedelic Studies (MAPS) founder and executive director, Rick Doblin, said in an interview with Fox Business Live that the FDA would approve MDMA-assisted therapy for PTSD in April or May of 2024.
Last year, MAPS announced the completion of the MAPP2 Phase 3 study, which is the organization’s second to use MDMA (3,4-methylenedioxymethamphetamine) therapy for PTSD treatment. The organization anticipates releasing data from the study in the first quarter of 2023.
In the Fox interview, Doblin said that the MAPP2 study achieved confirmatory results for treating PTSD.
Doblin underscored the importance of therapy in the Phase 3 trial. “It’s the therapy that is the primary active treatment, and the MDMA, the medicine, makes the therapy more effective,” he said in the interview.
He also noted that the Veterans Administration pays billions of dollars annually for disability, including for veterans with PTSD. According to a survey of more than 3,000 veterans, the lifetime prevalence of PTSD among veterans is 7%.
In early January, MAPS announced that MAPP2 met pre-specified primary and key secondary endpoints and that it planned to file a new drug application submission in the third quarter of 2023.
At the end of the Phase 3 MAPP2 study, two-thirds of MDMA recipients no longer met PTSD diagnostic criteria compared to one-third of placebo recipients.
Doblin also expects other psychedelic compounds, such as psilocybin and ibogaine, to win FDA approval.
Currently, those compounds remain Schedule I drugs with no legitimate medical use, according to the DEA.
Several for-profit public companies are currently conducting clinical trials for various psychedelic compounds, including COMPASS Pathways, Cybin, Atai Life Sciences and Awakn Life Sciences.
FDA granted breakthrough therapy designation to MDMA for PTSD in 2017.
Doblin founded MAPS in 1986. The organization is based in San Jose, California.
Merck first synthesized MDMA in 1912.