FDA advisers to weigh first psychedelic therapy in early June

Lykos Therapeutics’ MDMA-assisted therapy is charting yet another first in the psychedelic field: an FDA advisory meeting. 

The biotech will meet with the Psychopharmacologic Drugs Advisory Committee on June 4, according to a late Monday release. This will be the first time that FDA experts will formally debate a psychedelic treatment. Lykos (formerly known as MAPS PBC) is seeking FDA approval to use MDMA to treat patients with post-traumatic stress disorder. The drug is commonly referred to as ecstasy.

this will also be the first time in 25 years that the FDA will review a new treatment for PTSD, according to Lykos' announcement. 

Lykos has been the leading company in the psychedelic space, a field that has seen rapid growth and investment in the last year. It was the first psychedelic maker to apply for FDA approval and have an application accepted for review. 

CEO Amy Emerson called the meeting "an exciting milestone given the substantial unmet need for this patient population," in a statement to Fierce Biotech.

"The data that will be reviewed in the FDA Ad Comm will predominantly come from our six Phase 2 studies, two pivotal Phase 3 studies and a long-term follow-up study," she said. 


Both trials met their primary endpoint of improvement in PTSD symptoms compared to patients receiving placebo and psychological intervention. Other psychedelics, including psilocybin, LSD and N,N-Dimethyltryptamine (DMT) are in development to treat neuropsychiatric conditions. 

The prospect of an FDA approval catapulted Lykos to one of the largest private financings for a psychedelic company, raising $100 million in January. The FDA is set to decide on the therapy’s fate by the middle of August after Lykos submitted its application with priority review. Should it be approved, Lykos will have to wait for the Drug Enforcement Agency to reschedule MDMA to a lower category. The drug is currently a schedule 1 substance, along with heroin, marijuana and Quaalude, among others. The Biden administration is reportedly on the precipice of rescheduling marijuana to a schedule 3 drug, acknowledging the potential medicinal benefits.  

If rescheduled, then lobbying efforts will shift to individual states. Some have policies on the books that will immediately follow the DEA’s lead, while others will have to pass new legislation greenlighting MDMA’s use. 

Editor's note: This story was updated with a new statement from Lykos CEO Amy Emerson.