Filament Health CEO Ben Lightburn joined Steve Darling from Proactive to share the groundbreaking news that the U.S. Food and Drug Administration (FDA) has given its approval for the Investigational New Drug application for PEX010, Filament Health's botanical psilocybin drug candidate designed for the treatment of Substance Use Disorders.
This development paves the way for Filament Health to commence research activities in the United States, focusing on the potential use of their botanical psilocybin drug candidate in addressing substance use disorders, including those involving opioids.
Lightburn went on to explain that the IND-opening protocol had previously been submitted to Health Canada and had received the department's no-objection status, underlining the company's commitment to adhering to rigorous regulatory standards on both sides of the border.
Moreover, Lightburn highlighted the extensive scope of research and collaboration surrounding PEX010. Currently, a network of 24 research institutions and licensing partners across Canada, the USA, Europe, and Israel is actively studying PEX010 for various conditions. These include but are not limited to alcohol use disorder, depression, and coma, showcasing the versatile potential of this botanical psilocybin drug candidate in addressing a wide range of medical conditions.
The acceptance of the IND application by the FDA marks a pivotal moment in Filament Health's journey, offering a pathway for innovative and potentially transformative treatments for substance use disorders. It also underscores the company's global reach and collaborative efforts in advancing the field of psychedelic medicine. This milestone is a testament to the commitment of Filament Health to research and develop solutions that hold promise for individuals struggling with these challenging conditions.
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