Last year was tumultuous for the psychedelic medicine industry. Marked by the FDA’s rejection of Lykos Therapeutics’s MDMA-based depression treatment, experts project 2025 will be much more inconsequential, as companies are set to focus on recalibrating to avoid a similar fate.
Lykos’s MDMA therapy was widely expected to be the first FDA-approved psychedelic medicine. But the FDA rejected the company’s application in August, citing concerns about the data submitted. Lykos later agreed to complete a second Phase 3 clinical trial, though it has not announced when it would be able to resubmit its application for approval.
The agency’s decision showed that the psychedelic medicine industry still has a lot to prove to gain mainstream acceptance. But 2025 is off to a positive start, according to Lynn Marie Morski, president of the Psychedelic Medicine Association, pointing to the American Journal of Psychiatry dedicating its January edition entirely to psychedelic medicine.
“It was great to see such a long-standing organization from the mainstream medical side giving legitimacy to psychedelic medicine in that way,” Morski told Healthcare Brew. “It seems like this year is starting with an acknowledgement by some of the mainstream medical associations that…psychedelic medicine is a legitimate form of therapy.”
One of the main theories behind using psychedelic medicine to treat mental health conditions is that the drugs get to the root cause of conditions like anxiety or depression rather than just treating the symptoms, Morski told Healthcare Brew in May 2024. Providers could refer patients to various types of psychedelic therapy if they don’t respond well to traditional treatments, like SSRIs for depression.
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