The U.S. Food and Drug Administration has approved the investigational new drug application for Vancouver-based Filament Health Corp.’s (OTCQB: FLHLF) (NEO: FH) botanical psilocybin substance, PEX010, for clinical trials in treating substance use disorders.
This follows the company’s ongoing research in Canada, where PEX010 is being investigated for its efficacy in treating opioid use disorder.
“We believe that botanical PEX010 could offer a solution,” CEO Benjamin Lightburn said in a statement. “PEX010 is already under investigation for OUD in Canada, and this milestone allows us to build on that progress in the United States.”
The FDA’s decision is a regulatory milestone in the study of psychedelic compounds for therapeutic use in the country, with another major decision regarding MDMA looming in the distance.
Prior to the U.S. approval, Filament submitted its research protocol to Health Canada, where it did not raise any objections.
Filament’s research activities are not limited to North America; the company is involved in global studies across 24 institutions and partners in regions including Europe and Israel. These studies are examining the potential of PEX010 in treating various conditions, including alcohol use disorder, depression, and coma.
Filament last month scrapped a SPAC merger proposition in a quest to gain Nasdaq compliance after being advised that “material changes” would be needed to do so. The deal had already received initial approval from the exchange regulators and the firm even fished some funds to make sure it went through.
The company also said last year that it would take advantage of Canada’s new drug research laws by studying an import of Peruvian coco leaves for medical use. Regulators at the time reiterated that sales would only be allowed to pharmacies, hospitals, and researchers.