One of the most significant stories of 2025 was the FDA’s refusal of Lykos Therapeutics MDMA-assisted therapy trial. Many had viewed the impending success of this trial as a watershed moment for the industry. Once it was approved, it would undoubtedly open the door for others. In August of this year, however, they hit a wall.
The FDA issued a Complete Response Letter declining approval for the therapy. The rejection was based on several important factors. The agency cited inadequate safety data on the addiction potential of MDMA and a lack of long-term data on the durability of the treatment. Most damaging, though, were concerns with “functional unblinding”: the fact that participants are very much aware as to whether or not they have received a placebo. This makes it very difficult to rule out the placebo effect itself.
The FDA also made accusations of selection bias. Roughly 40% of the trial participants already had prior recreational experience with MDMA. This raised questions about whether or not the treatment would be effective for those who had never consumed and had no knowledge of the effects of the drug. Rick Doblin, the founder of MAPS, argued that the FDA had “moved the goalposts”, especially when related to the durability data. Other psychiatric medicines, he said, are not subject to such stringent requirements. This has stopped Lykos in its tracks completely and necessitated the organisation of a future (very expensive) Phase 3 trial.
While the FDA was slowing efforts to push psychedelic medicine into the mainstream, the DEA provided us with one of the year’s biggest surprises. In a move which delighted advocates across the US, the DEA formally directed the Department of Health and Human Services (HHS) to begin a scientific and medicinal review of psilocybin. This review was in service of a potential rescheduling of the substance. This was the first time ever that the DEA had prompted a review like this, rather than being pressed into action via external petitions. This appears to signal a large internal shift in attitude toward the therapeutic applications of psychedelics.
Furthermore, the DEA proposed quite drastic increases in the production quotas for psychedelics for 2026:
- Psilocybin – from 30,000 to 40,000 grams
- 5-MeO-DMT – from 11,000 to 30,000 grams
This massive increase in government-approved manufacturing of these substances signals again a thawing, changing attitude within the organisation. Regardless of the FDA’s hesitation regarding MDMA, the federal government appears to be anticipating a giant surge in demand for psychoactive substances, for research purposes, in the immediate future.
2025 also saw psychedelic discourse find its way into the highest levels of US politics. In an unexpected move, the “Make America Healthy Again” (MAHA) summit featured a panel dedicated to psychedelic medicine. The summit was attended by Trump administration officials, as well as Health Secretary Robert F. Kennedy Jr.
Kennedy himself faced private, psychedelic controversies as he faced allegations of past use of psychedelics, including smoked DMT, even though he professes complete sobriety. Kennedy has become a vocal advocate of psychedelic therapy, especially for veterans suffering from PTSD. This has created an odd new dynamic in which it is the conservative figures in government pushing for reform. However, this reform, of course, comes with a caveat. The focus is on strict medicalisation and profit, not decriminalisation or individual liberty.
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