FDA Green-Lights Filament’s IND Application for Botanical Psilocybin

The active IND allows Filament Health to initiate research of PEX010 for treatment of substance-use disorder, including opioid-use disorder.

The U.S. Food and Drug Administration has accepted the investigational new-drug (IND) application for PEX010, Filament Health Corp.’s botanical-psilocybin drug candidate for the treatment of substance-use disorders, the company said.

The IND-opening protocol previously had been submitted to Health Canada and received no objection from the department, according to Filament Health.

“The toxic drug crisis is a significant, growing problem in both Canada and the United States,” said Benjamin Lightburn, CEO and co-founder of Filament Health. ”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.”

Filament noted that 24 research institutions and licensing partners in Canada, the United States, Europe and Israel are studying PEX010 for conditions including alcohol-use disorder, depression and coma.