FDA moves to fast-track review of 3 psychedelic drug studies

The Food and Drug Administration (FDA) on Friday granted fast-track review to three companies studying psychedelic therapies to treat depression and post-traumatic stress disorder (PTSD), the latest step by the Trump administration toward possible approval. 

The agency did not disclose the specific companies that were granted priority review vouchers. Two companies are studying psilocybin; one for treatment-resistant depression (TRD) and the other for treatment of major depressive disorder. 

A third company is studying methylone, a drug similar to MDMA, for PTSD.  

“As this field moves forward, it is critical that their development is grounded in sound science and rigorous clinical evidence,” FDA Commissioner Marty Makaray said in a statement. “We owe it to our nation’s veterans and all Americans who are suffering from these conditions to evaluate these potential therapies with urgency.” 

Companies selected for the voucher program will be entitled to a shortened review time following filing of a New Drug Application. 

Shortly after the FDA announcement, Compass Pathways issued a press release announcing it had received one of the vouchers for its psilocybin-based candidate for TRD. 

“We are honored and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” which is the company’s proprietary formulation of synthetic psilocybin, said Kabir Nath, chief executive officer of Compass Pathways. 

In addition, the administration said it is allowing an early phase clinical study of a derivative of ibogaine to move forward. Miami-based DemeRx NB will research noribogaine hydrochloride as a potential treatment for alcohol use disorder. 

This is the first instance in which the FDA has allowed a clinical study in the U.S. of a derivative of ibogaine, a psychoactive derived from the African Tabernanthe iboga shrub. The move does not mean the treatment has been approved or found to be safe or effective.  

“We are accelerating the research, approval, and responsible access to promising mental health treatments – including psychedelic therapies like ibogaine – to confront our nation’s mental health crisis head-on, especially for our veterans,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement Friday. 

The vouchers were awarded following President Trump’s executive order last Saturday directing federal agencies to loosen restrictions and speed up research into psychedelic drugs.  

Most psychedelics are currently classified as Schedule I by the Drug Enforcement Administration — the strictest category – reserved for substances that have “no currently accepted medical use and a high potential for abuse.” 

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