Psychedelic company engaging psychedelic drug discovery and extraction to treat mental conditions Filament Health Corp. (NEO: FH) (OTCQB: FLHLF) announced having received an approval from the U.S Food and Drug Administration (FDA) to conduct a clinical trial using naturally extracted psychedelic substances.
Filament Health says this approval goes down on record as the first ever approved by the FDA direct administration of psilocin and the company will be administering its three proprietary botanical drug candidates.
The phase 1 trial will include 20 healthy participants and it will be seeking to find out the effect of the company’s three proprietary botanical drug candidates namely; PEX010- oral psilocybin, PEX020- oral psilocin, and PEX030- sublingual psilocin.
The clinical trials will first convert psilocybin to psilocin then administer it directly in the human body because when administered as psilocin it gives more therapeutic benefits compared to if administered as psilocybin.
Some of the benefits of administering the drugs as psilocin are; reduced side effects, faster onset time and greater consistency. The company’s CEO, Benjamin Lightburn, expressed how they are delighted to have been granted the FDA approval and how the clinical trial will change the psychedelics space.
“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. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation,” said the CEO.