Filament Health Announces FDA Opening of Investigational New Drug Application for Substance Use Disorders

VANCOUVER, BC, Jan. 31, 2024 /CNW/ – Filament Health Corp. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) (“Filament” or the “Company“), a clinical‐stage natural psychedelic drug development company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for PEX010, its botanical psilocybin drug candidate, for the treatment of Substance use Disorders (SUD).

“The toxic drug crisis is a significant, growing problem in both Canada and the United States. We believe that botanical PEX010 could offer a solution. PEX010 is already under investigation for OUD in Canada and this milestone allows us to build on that progress in the United States. Congratulations to the team at Filament for a major regulatory achievement.”

– Benjamin Lightburn, CEO and Co-Founder at Filament Health

The IND-opening protocol had previously been submitted to Health Canada and had received no objection from the department. In addition, 24 research institutions and licensing partners in Canada, the USA, Europe, and Israel are studying PEX010 for conditions including alcohol use disorder, depression, and coma.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (Cboe CA:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram, and LinkedIn.

Original Source