Psychedelic Drug Development Company Approved by FDA to Start First Psilocin Clinical Trial

The United States Food and Drug Administration (FDA) gave authorization to Filament Health Corp, an exclusively natural drug development company, to begin the first clinical trial on psychedelic substances from specifically natural sources.

The study will look into the onset times, bioavailability, side effects, and consistency levels of Filament’s three proprietary botanical psychedelic remedies: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). 

According to Green Market Report, the announcement saw Filament’s stock increase by 11% shortly after trading began.

“We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates. Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin and to enter them into an FDA-approved natural psychedelic clinical trial,” Filament’s Chief Executive Officer, Benjamin Lightburn, said.

The Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF) will lead the first trial and will include 20 healthy individuals.  

Psilocin and psilocybin are both naturally occurring compounds found in magic mushrooms. Psilocybin is metabolized into psilocin when it travels through the digestion system. The study trial will look into the therapeutic benefits of the drug. 

“My team and I are very excited to begin dosing Filament’s drug candidates in our clinic. The oral and sublingual administration presents an opportunity to learn about psilocin’s effects compared to psilocybin and perhaps set a new standard for psychedelic-assisted therapy,” Dr. Josh, MD/Ph.D., TrRP Director and Principal Investigator of the clinical trial study. 

If the trial goes well, the state and federal governments might be more open to legalizing psychedelic mushrooms for medical patients. The medication will most likely be stored and distributed in child-resistant, tamper-evident packaging, similarly to cannabis, which is highly, highly regulated.

Support for decriminalizing and legalizing psychedelics has increased throughout the United States. The City of Seattle’s Overdose Emergency Innovative Recovery task force and other supporters have recommended decriminalization of psychedelics to help curb opioid overdoses. In September, the United States Drug Enforcement Agency (DEA) posted a notice asking for increased production of psychedelics for federal research and clinical trials.