The article Filament Health Announces FDA Approval Of Phase II Clinical Trial was originally published on Microdose.

Filament Health has announced FDA approval of a Phase II clinical trial using psilocybin for Methamphetamine Use Disorder.

This is a major step for the small-cap firm, as it pushes them to the upper tiers of clinical trial stages. With Methamphetamine Use Disorder affecting a troubling number of people, this psilocybin-based trial may provide hope for patients.

Also, according to our interview with Filament’s CEO, the drug used in this trial already has proprietary IP in place.

For more on Filament, see our CEO interview and this announcement regarding recent patents.

See the full press release below.

The clinical trial will study PEX010, Filament’s botanical psilocybin drug candidate

 Vancouver, British Columbia, March 15, 2023 – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament”or the “Company”), a clinical‐stage natural psychedelic drug development company, today announced approval from the United States Food and Drug Administration (FDA) for a clinical trial at the University of California San Francisco’s Translational Psychedelic Research Program (TrPR) The investigator initiated trial will study the effects of PEX010, Filament’s botanical psilocybin drug candidate, for the treatment of methamphetamine use disorder (MAUD).

MAUD is a growing public health emergency that is associated with serious health consequences. In the United States, the prevalence and mortality of MAUD has doubled over the past decade, yet available treatments have limited efficacy. Psilocybin offers a possible breakthrough – a single dose has been found to dramatically increase abstinence and reduce consumption in individuals with substance use disorders. The goal of this trial will be to determine the safety, tolerability, and feasibility of psilocybin therapy for people living with MAUD.

“We’re pleased to support this much-needed research,” said Benjamin Lightburn, Chief Executive Officer and Co-Founder of Filament Health. “This trial is the first time that naturally-derived, non-synthetic psilocybin will be studied for methamphetamine use disorder, and represents an important step for Filament into the treatment of substance use disorders.”

ABOUT FILAMENT HEALTH (OTCQB:FLHLF)(NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health

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