FDA Designates Psilocybin as “Breakthrough Therapy” for Severe Depression

By Matt Agorist

For years, those who have been following and even participating in the benefits of psilocybin have understood and read about the ability of magic mushrooms to combat a number of ailments. From helping the terminally ill come to grips with their own mortality to treating PTSD and depression — psilocybin has a wide range of benefits. Up until recently, however, the government has ignored these benefits and prosecuted those for seeking them out. All that is now changing though, and the US Food and Drug Administration (FDA) has just granted Breakthrough Therapy status to psilocybin for its ability to clinically treat depression.

It is estimated that roughly 7% of the entire United States adult population has had at least one major depressive episode. That number represents over 17 million people, according to the most recent figures out of the National Institute of Mental Health. These numbers are concerning as they have been increasing year after year.

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Despite the growing number of people prescribed antidepressants, depression rates continue to climb. It is time to try something new; and while the government usually hinders the process of trying new things, because things have gotten so out of hand the FDA seems ready to break that paradigm. The FDA has granted psilocybin therapy a Breakthrough Therapy designation in hopes of curbing the ever-increasing rates of depression.

According to the FDA,

Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for breakthrough therapy designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

A breakthrough therapy designation conveys all of the fast track program features, more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and eligibility for rolling review and priority review.

This designation is most often requested by pharmaceutical companies seeking to fast track their new drugs to the market. It is rare that natural medicines like psilocybin are considered for such designation. However, this is the second year in a row that the FDA has given this designation to psilocybin.

The 2018 breakthrough status has focused on psilocybin’s potential to treat severe treatment-resistant depression, or depression in patients who have not improved after undergoing two different antidepressant treatments, according to New Atlas.

As New Atlas reports:

Back in late 2018, the FDA granted Breakthrough Therapy status to the ongoing work from COMPASS Pathways investigating psilocybin, the key psychoactive compound in magic mushrooms, as a therapy for treatment-resistant depression. A large, multi-center Phase 2 trial spanning the US, UK and Europe is currently underway testing a variety of dosing strategies.

This new FDA Breakthrough Therapy approval focuses on a seven-site, Phase 2 trial currently underway in the United States. Coordinated by a non-profit research organization called the Usona Institute, the trial is exploring the antidepressant properties of a single psilocybin dose in treating patients with major depressive disorder (MDD).

“What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” Dr. Charles Raison, the director of clinical and translational research at Usona, said in the statement.

These benefits, although they are now being accepted by the state, have been known about for some time. For years, the Free Thought Project has been reporting on the beneficial effects of psilocybin mushrooms ranging from treating PTSD to addiction and depression. In the land of the free, however, in all places except for Oakland and Denver, cops will kidnap and cage you for having them.

The FDA designation illustrates that resistance to this tyranny is growing and at least one dispensary in Canada is defying the law as well and selling medicinal magic mushrooms online for people with depression and other ailments.

It appears that the push for legalizing mushrooms may be happening just as fast as marijuana and this is amazing news — not just for recreational users, but for people who can benefit from psilicybin.

What’s more, it paves the way for people who are now taking dangerous pharmaceuticals to transition into a much safer treatment.

As TFTP reported last year, a study, published in the scientific journal Neuropharmacology, found that clinically depressed people could benefit from psylicibin.

“Psilocybin-assisted therapy might mitigate depression by increasing emotional connection,” neuroscientist and study author Leor Roseman, a Ph.D. student at Imperial College London, explained to PsyPost.

This is almost the exact opposite of how standard anti-depressants operate, as SSRI’s typically work by creating an “emotional blunting.”

“[T]his is unlike SSRI antidepressants which are criticized for creating in many people a general emotional blunting,” noted Roseman.

“I believe that psychedelics hold a potential to cure deep psychological wounds, and I believe that by investigating their neuropsychopharmacological mechanism, we can learn to understand this potential,” explained Roseman.

The government also stands to lose if more people start using psilocybin.

As TFTP previously reported, mushrooms and psychedelics used to be widely accepted as a treatment for many ailments until government moved in to stop the expansion of human consciousness.

In the 1940s, Western medicine began realizing the potential for psychedelics to treat addiction and psychiatric disorders. Tens of thousands of people were treated effectively, and psychedelic drugs were on the fast track to becoming mainstream medicine. But the beast of oppression reared its ugly head.

In 1967 and 1970, the UK and US governments cast all psychedelic substances into the pit of prohibition. People were waking up to the fact that governments intended to keep the world in a state of war, and that governments were working to keep the populace sedated under a cloak of consumerism. The collective mind expansion of that era came to a screeching halt under the boot and truncheon.

As John Vibes pointed out last January, a study actually confirmed the fear of authoritarians and showed they have every reason to oppose legal mushrooms. According to the study from the Psychedelic Research Group at Imperial College London, published in the journal Psychopharmacology, psychedelic mushrooms tend to make people more resistant to authority. They also found the psychedelic experience induced by these mushrooms also cause people to be more connected with nature.

“Our findings tentatively raise the possibility that given in this way, psilocybin may produce sustained changes in outlook and political perspective, here in the direction of increased nature relatedness and decreased authoritarianism,” researchers Taylor Lyons and Robin L. Carhart-Harris write in the study.

Now, as people share information globally, instantaneously, on a scale unstoppable by the state, we are resuming the advancement of medical research on psychedelic substances like psilocybin. Scientists are challenging the irrational classification of psychedelics as “class A” (UK) or “schedule 1” (US) substances, characterized as having no medical use and high potential for addiction. And, the recent pushes in Colorado, Oakland, and Canada are evidence of this.

After 40 years, it appears that another brick in the wall of prohibition is beginning to crumble in the face of science and logic.

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