The first-ever authorised export of GMP-compliant natural psilocybin into the US has been completed.
Psychedelic drug development company, Filament Health Corp., recently completed a shipment of Good Manufacturing Practices (GMP) compliant psilocybin into the US in what is believed to be a first-of-its-kind export.
The delivery was shipped from Filament’s Vancouver facility to the University of California San Francisco‘s (UCSF) Translational Psychedelic Research Program, for a phase 1 FDA trial and ongoing clinical trial partnership.
Major milestone for clinical research
The export, which consisted of capsules containing Filament’s proprietary formulation which is precisely standardised to include 25 milligrammes of natural psilocybin, represents an important step in advancing clinical research on natural psilocybin.
The capsules were manufactured in-house in accordance with its Health Canada Dealer’s License and were delivered to the programme via a Health Canada export permit and US Drug Enforcement Administration import permit.
CEO of Filament Health, Benjamin Lightburn, commented: “This is an important milestone for Filament as we have demonstrated our ability to transport a controlled substance – in this case standardised psilocybin extract – for our own research purposes. It also opens the door to working with other international licensed research sites.
“We believe that this is the first transborder shipment of naturally-extracted GMP psilocybin – an achievement which validates our regulatory team’s work and affirms our ability to work closely with government agencies in Canada and abroad.”
The shipment followed Filament Health being issued the first patent for the extraction and standardisation of natural psilocybin on 3 August, 2021 and an amendment to its Health Canada Dealer’s License, allowing for work with all natural psychedelics, on 29 July, 2021.
