Federal health regulators have declined to approve the use of the psychedelic drug MDMA for treating PTSD, delivering a significant setback to groups advocating the use of mind-altering substances for mental health conditions. The FDA’s decision comes after a panel of advisors voted against the drug’s use in June, citing concerns over safety and efficacy. The drugmaker, Lykos Therapeutics, plans to request a reconsideration of the decision, but the additional late-stage study requested by the FDA could take several years and millions of dollars to conduct.
If approved, MDMA would have been the first illegal psychedelic to become a federally approved medicine, paving the way for other hallucinogenic drugs to enter mainstream medical use. Despite the setback, advocates of psychedelic therapy remain hopeful, as other psychedelics are expected to undergo FDA review in the coming years. The use of psychedelics in psychotherapy is not a new concept, with some therapists using MDMA in the 1970s and 1980s for couples therapy.
The FDA’s decision highlights the challenges of conducting research on psychedelics, with concerns raised about blinding in studies and allegations of misconduct. Despite these setbacks, research into the therapeutic potential of psychedelics is ongoing, with other substances like psilocybin and LSD being studied for conditions such as depression, addiction, and anxiety. Two drug developers are currently conducting late-stage studies on psilocybin for severe depression.
While the FDA’s decision is a blow to advocates of psychedelic therapy, the agency has expressed a commitment to encouraging innovation for psychedelic treatments and other therapies to address medical needs. The future of psychedelic therapy remains uncertain, but ongoing research and advocacy efforts continue to push for the inclusion of these substances in mainstream medicine.
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