Filament Health Corp (NEO:FH, OTCQB:FLHLF) announced that the United States Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for its botanical psilocybin drug candidate PEX010 for the treatment of substance use disorders, including opioid use disorder.
The company said that the active IND allows for the initiation of research in the US using PEX010.
The IND-opening protocol had earlier been submitted to Health Canada and received no objection from the regulator.
PEX010 is already being studied for a range of conditions including alcohol use disorder and depression by 24 research institutions and licensing partners in Canada, the United States, Europe and Israel, the company highlighted.
"The toxic drug crisis is a significant, growing problem in both Canada and the United States," Filament Health CEO Benjamin Lightburn said in a statement.
"We believe that botanical PEX010 could offer a solution. PEX010 is already under investigation for opioid use disorder 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 Health is a clinical-stage natural psychedelic drug development company.