Advocates have long pushed for MDMA-assisted therapy, which combines the drug with talk therapy under the guidance of a licensed therapist.
MDMA helps release serotonin and oxytocin, allowing patients to process trauma in a non-threatening way. However, MDMA remains a Schedule 1 drug, classified as illegal since the 1980s, complicating efforts to approve it for therapeutic use.
Despite years of advocacy, the FDA recently rejected an application by Lykos Therapeutics to use MDMA for PTSD treatment, citing insufficient evidence and requiring another Phase 3 trial, which could take several years. This decision came after concerns from an FDA advisory panel about the design of Lykos’ trials, particularly the lack of effective placebo controls. Further damaging Lykos’ credibility, three of their studies were retracted due to unethical conduct.
Australia has moved ahead of the U.S., allowing psychiatrists to prescribe MDMA for PTSD and psilocybin for treatment-resistant depression. However, access to these treatments is limited, requiring psychiatrists to go through a rigorous approval process. The treatments are also expensive, with a nine-month MDMA therapy program costing up to AUD 27,500 (around USD 18,200), making it accessible to only a small segment of the population.
In summary, while MDMA shows promise in treating PTSD, regulatory hurdles, ethical concerns, and high costs mean that widespread availability in the U.S. remains uncertain and likely years away. Meanwhile, Australia’s cautious adoption may offer some lessons, though it also underscores the limited accessibility of such treatments.