Filament Health Corp. Gains FDA Approval for Psilocybin Clinical Trials

LOS ANGELES- The U.S. Food and Drug Administration (FDA) has recently granted an investigational new drug application to Vancouver-based Filament Health Corp. (OTCQB: FLHLF) (NEO: FH) for its botanical psilocybin substance, PEX010. This approval marks a significant stride for Filament, enabling the firm to conduct clinical trials in the United States aimed at treating substance use disorders.

The green light from the FDA follows Filament’s ongoing research efforts in Canada, where PEX010 is currently under investigation for its potential in treating opioid use disorder (OUD). Benjamin Lightburn, CEO of Filament Health, expressed optimism about the development, stating, “We believe that botanical PEX010 could offer a solution.” He emphasized the importance of building on their Canadian research progress with the expansion into the U.S. market.

This development is not just a company milestone but also represents a regulatory landmark in the United States for the study of psychedelic compounds for therapeutic use. The FDA’s approval arrives at a time when the country anticipates another significant decision regarding MDMA, another compound under consideration for therapeutic applications.

Prior to receiving the nod from the U.S. authorities, Filament had submitted its research protocol to Health Canada, which raised no objections to the proposed studies. This smooth transition into U.S. clinical trials underscores a growing interest and acceptance of psychedelic research in North American regulatory circles.

Filament Health’s research scope extends well beyond North America, with the company actively involved in global studies across 24 institutions and partners in various regions, including Europe and Israel. These studies aim to explore the efficacy of PEX010 in treating a range of conditions such as alcohol use disorder, depression, and even coma.

In a related development, Filament recently withdrew from a proposed SPAC merger, seeking to achieve Nasdaq compliance through other means. This decision came after being advised of the need for “material changes” to facilitate the merger, which had initially received preliminary approval from exchange regulators. The firm had even secured funding to ensure the successful completion of the deal.

Additionally, Filament disclosed last year its plans to capitalize on Canada’s evolving drug research laws. The company expressed its intention to study the medical use of imported Peruvian coca leaves, aligning with the Canadian regulatory framework that permits sales exclusively to pharmacies, hospitals, and research institutions.

This series of strategic moves by Filament Health Corp. not only highlights the company’s agility in navigating complex regulatory landscapes but also underscores the burgeoning interest in the therapeutic potential of psychedelic compounds in both the medical community and the regulatory authorities. As these clinical trials progress, the implications for the treatment of various substance use disorders could be substantial, potentially opening new avenues in the field of psychedelic medicine.