FDA Approves Magic Mushrooms for Treating Depression

December 14, 2021 Uncategorized

Surprisingly enough, the FDA approves magic mushrooms for treating depression, at least in some respect. The FDA is working to enhance how psilocybin, a hallucinogenic compound found in magic mushrooms, research is completed as it is related to major depressive disorder (MDD).

But what’s going on exactly? And is this an opportunity for mushroompreneurs?

In this post, we provide insight into what the FDA has been doing, how consumers will benefit, and why shroompreneurs can consider magic mushroom endeavors a lucrative opportunity.

Interested in psychedelics? Make sure to check out our other post “What States are Psychedelics Legal in 2022.”

FDA Approves Magic Mushrooms for Treating Depression

FDA Speeding the Process for Magic Mushroom Research

In 2019, the U.S. Food and Drug Administration designated psilocybin therapy as a “breakthrough therapy,” despite the fact that it’s currently being tested in various clinical trials. This action was done with a purpose: to speed up the slow process of drug development and review.

Most of the time, drug companies request this action. But it’s only something that’s granted if there is preliminary evidence highlighting a drug’s impressive improvement over the currently available therapies, as stated by the FDA.

The year before, the FDA gave psilocybin therapy its “breakthrough therapy” status as Compass Pathways, a company delving into psilocybin’s potential to treat severe treatment-resistant depression, was conducting clinical trials. But mushroom possession is still technically prohibited in most states.

Since the FDA granted another “breakthrough therapy” status to this psychedelic treatment will undergo a U.S.-based clinical trial to be conducted by Usona Institute, a nonprofit organization. During this clinical trial of 80 participants located at seven different sites throughout the U.S., researchers will focus on understanding the efficacy of treating MDD patients with a single dose of psilocybin.

More on The Research

The phase 2 trial was expected to finish earlier in 2021. With assistance from this status, Usona believes it has the opportunity to shift into a larger phase 3 trial. With one in three treatments given the Breakthrough Therapy status moving on to get market approval, the chance that these drugs will become available is quite high.

“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, director of clinical and translational research at Usona, is quoted as saying during a statement.

Magic Mushrooms for Treating Depression

Psychedelic research has been ongoing as a potential treatment for depression. In March of 2019, the FDA approved a nasal spray depression treatment for those with treatment-resistant depression in Europe. This spray contains Esketamine, a substance comparable and related to ketamine.

With drugs comparable to psilocybin hitting the market already, we believe it’s only a matter of time for the same to occur in the U.S. This is where the opportunity for shroompreneurs becomes apparent.

But looking at the studies on psilocybin treatment for depression, it becomes even more obvious that it’s only a matter of time before we begin seeing a legal magic mushroom marketplace.

One study published in the New England Journal of Medicine outlined the advantages of using psilocybin to treat depression. Other studies explain how psilocybin-assisted therapy for patients with MDD suggests “substantial rapid and enduring” antidepressant effects worth noting.

Magic Mushrooms for Depression: A Shroompreneur Opportunity

In mental health disease, unmet needs result in the space welcoming promising treatment options. At this point, the U.S. has beyond 17 million people living with major depressive disorder. This severe depression lasts in excess of two weeks.

However, if just a single dose of psilocybin has the potential to profoundly impact the brain and offer long-lasting effects after clearing the patients of depressive symptoms, the opportunity for shroompreneurs is significant.

Looking at psilocybin, over the last few years, we’ve observed this drug go from being completely banned as a Schedule I drug to what some researchers recommend should be a Schedule IV controlled substance. The difference between a drug that has “no currently accepted medical use and a high potential for abuse” and a drug with relatively low potential for abuse is massive, and with the possibility that it can help patients suffering from MDD, the moment it’s allowed, we can expect people to capitalize on the legal marketplace.

According to Fortune Business Insights, the global market size for anxiety disorders and depression treatment was $8.5 billion in 2019. This industry is expected to reach $13.03 billion by 2020, offering insight into how massive the potential is with magic mushrooms for depression.

Even if the legal magic mushroom marketplace can obtain a small percentage of the current anxiety and depression treatment market, shroompreneurs have the potential to capitalize on it.

Magic Mushrooms for Treating Depression FAQ

Can magic mushrooms be used to treat depression?

Yes. After attending to the FDA, magic mushrooms for treating depression can be used in expert medical environments to help treat depression.

Is psilocybin harmful?

To definitively say whether or not psilocybin is harmful, more research is necessary. However, there is no evidence to suggest that psilocybin is harmful when used in a controlled setting.

Can magic mushrooms be addictive?

No. There is no evidence to suggest that magic mushrooms are addictive. In fact, many people report feeling a sense of euphoria and pleasure when using them.

What psychedelic drugs are FDA approved?

To date, most psychedelic drugs have not been approved. However, this is expected to change in the near future as more research becomes available on their potential for treating various mental health disease.

Can psilocybin be used to treat anxiety?

Yes. There is already extensive research demonstrating that psilocybin is effective when used for treating anxiety disorders.

Can mushrooms replace antidepressants?

While mushrooms – including but not limited to magic mushrooms – can replace antidepressants, more research is necessary to make this claim definitively. However, the early research looks promising.

What are the risks associated with using magic mushrooms for depression?

The risks associated with using magic mushrooms for depression vary depending on a person’s mental health history and other factors. However, in a controlled setting, the risks are relatively low.

Concluding on this Mushroompreneur Opportunity

Depression is a widespread problem that impacts millions of people. While there are many existing treatments, not all of them work for everyone. Psilocybin has been shown to be an effective treatment for depression and has a low potential for abuse.

This makes it a promising option for those who struggle with this condition.

As the legal landscape around psychedelics continues to change, shroompreneurs have the opportunity to capitalize on this growing market.

Pairing the research surrounding this with a legal, regulated market presents a massive opportunity for shroompreneurs to improve people’s lives. But for those just now finding out about this emerging marketplace, how can you get started?

From developing products and services related to psilocybin treatment to building a website or simply driving traffic to your existing website, there are many options available when it comes to entering this market. But, if you’re considering getting involved in the legal marketplace before psilocybin becomes legal, other legal medicinal mushrooms exist.

Reiki mushrooms and their derivatives are a great place to start. These mushrooms have been shown to help with anxiety and depression and offer a wide variety of therapeutic benefits.

This is just the beginning for the shroom market in 2021. As more research comes in on the medical benefits of psychedelics, it’s clear that this is an industry with massive potential.

Looking for help scaling your mushroom operation? Northstar is ready to help!

Contact us now to speak with an expert CPA and learn how we can use the right financial insight to grow your mushroom business.