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.
Keeping an eye out
While no FDA decisions on psychedelic medicines are slated for 2025, industry stakeholders are looking forward to the release of certain Phase 3 clinical trial results.
Morksi, for one, said she’s looking out for results from Compass Pathways, a UK-based biotech company working to develop a psilocybin therapy for treatment-resistant depression, which is expected to be released in Q2 this year.
Compass laid off 30% of its workforce in October 2024 to reorganize its business to focus solely on psilocybin therapy. The company had been working on several other psilocybin clinical trials, including testing the drug as a treatment for anorexia nervosa and post-traumatic stress disorder. The company reported a $111.8 million loss for the first three fiscal quarters of 2024.
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Three other companies have psychedelic medicines in Phase 3 trials: Wisconsin-based Usona Institute, which is testing psilocybin to treat major depressive disorder; Canada-based Awakn Life Sciences, testing ketamine for alcohol use disorder; and New York City-based MindMed, testing LSD for generalized anxiety disorder.
However, all those trials are still in early stages, and it’s unclear when they’ll report results, Morski said.
Revamping trials
This year, companies developing psychedelic medicines will focus on making sure they learn from Lykos’s missteps, according to Fran Brown, SVP of drug development solutions at pharma consulting firm Certara.
Executives at Cybin—a Canadian biopharmaceutical company developing a psilocin-based treatment for major depressive disorder—said in November they were adjusting plans for their upcoming Phase 3 clinical trial to take into account some of the concerns the FDA raised regarding Lykos’s application.
For instance, Cybin plans to give trial participants the psilocin treatment along with their regular antidepressants instead of requiring them to stop using their medications like in the Lykos trial.
Cybin also plans to hold a 12-week blinded period to “maximize the number of patients that remain in the study through the blinded stage,” Doug Drysdale, Cybin’s CEO, said in a statement. One of the FDA’s issues with the Lykos trial was the “functional unblinding,” which means many participants could guess if they were getting the placebo versus the MDMA therapy.
“[Cybin is] going to be filing later than they’d originally planned, but they probably have the greatest surety of success because of that,” Brown said. “By and large, this is a year of consolidating and thinking, ‘How do you actually generate robust and equivocal data in this very difficult space?’”