FDA Fast-Tracks Psilocybin and Methylone for Depression and PTSD Treatment

Six days after President Donald Trump signed an executive order to expedite regulatory reviews of psychedelics with potential as psychotherapeutic treatments, the U.S. Food and Drug Administration (FDA) issued national priority vouchers for two promising psychedelics: psilocybin for depression and methylone (also known as MDMC) for post-traumatic stress disorder (PTSD).

The FDA had previously designated both drugs as breakthrough therapies, indicating they may offer substantial improvement over existing treatments. While breakthrough status already accelerates review processes, the new vouchers promise an ultra-fast timeline of just one to two months after required studies are completed—significantly faster than the standard six months or more.

FDA Commissioner’s Statement on Psychedelic Therapies

"Psychedelics have the potential to address the nation's mental health crisis, including conditions like treatment-resistant depression, alcoholism, and other serious mental health and substance abuse conditions," said FDA Commissioner Marty Makary. "As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence. We owe it to our nation's veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency."

Psilocybin: Breakthrough Therapy for Treatment-Resistant Depression

The FDA recognized psilocybin as a breakthrough therapy in 2018 following preliminary studies showing dramatic psychological improvements in patients with treatment-resistant major depression and those with life-threatening illnesses.

• Compass Pathways, a London-based biotech company, is conducting Phase 3 clinical trials to secure FDA approval for its synthetic psilocybin as a prescription drug for treatment-resistant depression.
• The Usona Institute, a nonprofit based in Madison, Wisconsin, is running a Phase 3 trial of psilocybin for patients diagnosed with major depressive disorder.
• The FDA is also reviewing an application from Helus Pharma (formerly Cybin), a Canadian company testing psilocin—the active metabolite of psilocybin—in Phase 3 trials for the same indication.

Methylone: Breakthrough Therapy for PTSD

Last year, the FDA designated methylone—a compound similar to MDMA—as a breakthrough therapy based on a Phase 2 trial that demonstrated "rapid, robust, and durable improvements" in patients with severe PTSD.

Transcend Therapeutics, a neuropsychiatry company in New York City, has since initiated Phase 3 trials of methylone as a PTSD treatment.

Trump Administration’s Push for Psychedelic Research

In addition to the vouchers for psilocybin and methylone, the FDA approved an early-phase clinical study of ibogaine as a potential treatment for alcohol use disorder. This marks the first human trial of ibogaine in the U.S., a substance also being explored for PTSD treatment.

"This is significant in that it speeds up access," said Melissa Lavasani, founder and CEO of the Psychedelic Medicine Coalition, in a statement to CNN following Trump’s executive order. "It speeds up these drugs being