The FDA to Begin Studies on Magic Mushrooms, a First For the Agency



The US Food and Drug Administration (FDA) just green-lighted Filament Health Corporation, a clinical-stage company in the natural psychedelic medicine development business, to do a study on the effects of certain psychedelic drugs.



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Filament has already created around 70 strains of psychedelic mushrooms to be used for research, and they were able to raise a cool $2.5 million to continue studying the use of psychedelics through stabilized formulas. These would offer patients the benefits of better bioavailability, consistency, and a quicker onset as well as a reduction in side effects.

This the first FDA-approved study on psychedelics in its history. The trial’s first phase will be taking place at the University of California, San Francisco’s Translational Psychedelic Research Program (TrPR) with Dr. Joshua Woolley at the helm. Another interesting milestone for this study is that it will also be the first FDA-approved study to use natural psilocybin and psilocin from mushrooms, whereas previous studies only used synthetic mushrooms, says a press release.

The trial intends to study 3 of Filament’s natural drug candidates which have been extracted naturally then stabilized. The researchers intend to analyze the effects of psilocybin and psilocin when administered orally as well as sublingually to healthy adults.

“We are incredibly proud to have reached this milestone in an FDA-approved trial,” says Benjamin Lightburn, Filament CEO and co-founder. “We look forward to increasing the scientific understanding of potential benefits and applications for natural psychedelic medicines, and to getting these treatments to those in need,” he adds.

RELATED: Elon Musk Says People Should Be Open to Psychedelics

Will psychedelics follow legalization blueprint of marijuana?

There’s no doubt about it: It’s clear psychedelics are now being taken seriously by stakeholders, Big Pharma, and investors because it has the potential of replacing numerous pharmaceutical drugs just in the next few years.

The psychedelic revolution is upon us, and the movement to legalize or at least decriminalize what were once known as party drugs – such as MDMA, magic mushrooms, and LSD – because of their powerful therapeutic potential. It’s also the same movement that helped decriminalize – and eventually destigmatize – cannabis in recent history.

What will this all mean for the future of psychedelics? Would we one day be able to access a wide range of regulated psychedelics the way we do with pharmaceutical medications?

RELATED: What’s in the Future for Cannabis and Psychedelics? Industry Leaders Weigh In.

What this means for the future

Recently, the FDA gave MDMA and psilocybin breakthrough therapy status, which means that they already recognize both substance’s ability to treat a range of serious conditions. This designation means that they encourage more research on psychedelics which is necessary for drugs to be approved. Back in 2019, they already approved esketamine for use in treatment-resistant depression while other researchers are working on studies to seek FDA approval for MDMA and psilocybin to treat major depression and post-traumatic stress disorder, two of the most challenging mental health conditions today.

Thanks to the work of many advocacy and research groups, most especially The Multidisciplinary Association for Psychedelic Studies (MAPS), Drug Policy Alliance, and many more which have provided significant contributions to help decriminalize other drugs aside from cannabis.

Surely, at least some of your own friends if not yourself included, have already dabbled in some psychedelics to experiment. Yes, the health benefits are real but the strong movement isn’t really motivated by money. But just like with cannabis, there’s money to be made in psychedelics, though the fight to total legalization is still ongoing. We have to fight to break down what the failed War on Drugs did – only leaving us with a stigma and, a few years ago, difficulty accessing these medications. However, more organizations are focusing on the importance of medical research to break through the other side. Science, at least eventually, will always win and prove the argument is right: natural medicine, such as psychedelics and cannabis, do work and are far better than pharmaceutical drugs.

We still have a long way to go: even if the FDA has approved the use of psychedelic drugs, there’s still the Drug Enforcement Agency (DEA) to deal with, which for sure will mean other hurdles to go through. And even if the FDA approves psychedelic drugs, the DEA will have to re-examine it, and doctors won’t be able to prescribe psychedelic drugs until the DEA changes the schedule of these drugs.

Thankfully, several cities around the United States have already made moves: either by decriminalizing and legalizing, reducing penalties, have assigned working groups to study its medical use, or there are active legislations in place. Oregon made history in November 2020 by being the first state to remove all criminal penalties for illegal drugs including all psychedelic substances as well as heroin, cocaine, methamphetamine, and oxycodone. A very bold move, indeed.

Santa Cruz and Oakland soon made psilocybin and other entheogenic plants such as mescaline, iboga, and ayahuasca on the lowest priorities of law enforcement, followed by the District of Columbia, Denver, Ann Arbor, Northampton, Cambridge, Somerville, Seattle, and others enacting similar laws.

These are all massive signs of progress being made though legally it will still take some time for psychedelics to be as widely available as cannabis is today. However, we can expect more developments in the near future – which is critical to benefit millions of people all around the country struggling with difficult-to-treat mental disorders. Let’s just hope our legislators give it the priority that it deserves.



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