MDMA-assisted therapy for PTSD may gain FDA approval by early 2027, but a severe shortage of qualified therapists could limit access

MDMA-assisted therapy for post-traumatic stress disorder may receive FDA approval by early 2027, according to Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies. His optimism follows Resilient Pharmaceuticals' reported resubmission of an application after the FDA rejected the treatment in 2024 over concerns about clinical trial reliability, safety and effectiveness. The new filing reportedly relies on additional research, including long-term follow-up from a Veterans Affairs study, rather than the new Phase 3 trial previously requested. Support has also grown through federal psychedelic research initiatives, Department of Defense and VA interest, and pharmaceutical investment. However, approval would not ensure broad access. Advocates and clinicians warn that the US lacks enough qualified therapists, training infrastructure and insurance reimbursement to serve the estimated 13 million adults with PTSD. MAPS plans to begin US therapist training in December, while Doblin cautions that expansion must match the availability of properly trained providers.