FDA-Approved Study to Investigate Therapeutic Potential of Mushroom-Derived Psilocin and Psilocybin

Filament Health has begun its Phase 1 study investigating naturally-derived psilocin and psilocybin, the first such study ever approved by the FDA.

Full story after the jump.

Filament Health, a clinical-stage natural psychedelic drug development company, has announced the start of a first-of-its-kind study in which psilocin and psilocybin derived from mushrooms — rather than constituents created in a lab — will be administered to patients.  

Overseen by Dr. Joshua Woolley at the University of California San Francisco’s (UCSF) Translational Psychedelic Research Program (TrPR), the Phase 1 study is approved federally by the Food and Drug Administration (FDA) and will examine the effects of naturally-derived psychedelic substances.  

The trial will use three of Filament’s botanical drug candidates and assesses the physiological and psychological effects of orally administered psilocybin, orally administered psilocin, and sublingually administered psilocin to healthy adults over a series of doses.   

“We are incredibly proud to have reached this milestone in an FDA-approved trial. We look forward to increasing the scientific understanding of potential benefits and applications for natural psychedelic medicines, and to getting these treatments to those in need.”  — CEO and Co-Founder Benjamin Lightburn, in a statement

In the past, drug makers have been unable to properly synthesize psilocin instead of its pro-drug form psilocybin. The hope is that naturally-derived psilocin may offer greater consistency, increased bioavailability, faster onset time, and lessened side effects, according to the press release. 

“We are excited to conduct the first trial of naturally sourced psilocybin and the first modern trial of psilocin from any source,” Dr. Joshua Woolley, MD/Ph.D., director of TrPR and the study’s principal investigator, said in a statement. “This trial will provide crucial information about the effects and mechanisms of these compounds that could allow for greatly enhanced psychedelic-assisted therapy.” 

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