Mental illness is the leading cause of disability in developed countries. In fact, half of Americans will experience mental illness in their lifetime and $350 billion is spent each year on treating depression in the U.S. and Europe alone. Psychedelics have emerged as a breakthrough treatment for many mental health disorders with fast-acting results, long-lasting effects and far fewer adverse side-effects than the current treatment standards. 

After Johns Hopkins launched its Center for Psychedelics & Consciousness Research with $17 million in private funding and a full panel of planned research studies, researchers published the results of an inaugural study showing that two doses of psilocybin with supportive psychotherapy produced rapid and large reductions in depressive symptoms along with half of participants achieving remission through the four-week follow-up period.

“The magnitude of the effect we saw was about four times larger than what clinical trials have shown for traditional antidepressants on the market,” said Alan Davis, Ph.D., Assistant Professor of Psychiatry and Behavioral Science. “Because most other depression treatments take weeks or months to work and may have undesirable effects, this could be a game-changer if these finds hold up in future ‘gold-standard’ placebo-controlled clinical trials.” 

Around the same time Johns Hopkins published its groundbreaking research, the U.S. Food and Drug Administration (FDA) approved a nasal spray containing esketamine—a psychedelic substance—called Spravato for patients who are having suicidal thoughts. Studies showed that more than 40% of suicidal patients who received four weeks of treatment had greatly reduced symptoms of depression at the end of the period—far more effective than other options.

Research and Markets believes that the global market for these kinds of psychedelic treatments could reach $10.75 billion by 2027, driven by an accelerating pace of research breakthroughs and a growing number of clinical trials addressing everything from post-traumatic stress disorder to generalized anxiety disorder. Not surprisingly, many public and private companies have also started to develop therapeutics in the space—and investors should pay attention.  

Revive Completes Thin Film Research 

Revive Therapeutics Ltd. (CSE: RVV) (OTC: RVVTF) is a specialty life sciences company that, among other things, is focused on developing psilocybin-based treatments for a range of mental illnesses, neurological conditions and substance abuse disorders. The team’s primary focus is on a revolutionary thin-film delivery system, which provides rapid onset into the bloodstream and a convenient way for patients to consume medication.

In partnership with the Reed Research Group at the University of Wisconsin-Madison, the company showed that psilocybin could be incorporated into chitosan-tannin composite hydrogel and cast into molds to create stable, flexible thin films after drying, as well as release psilocybin upon dissolution into water. The company filed a provisional patent and is now in discussions with contract manufacturers to scale up production for upcoming clinical studies.

“We are pleased with the final conclusion of the research work and its successful results as it validates our drug delivery technology in delivering psychedelic pharmaceuticals and positions our oral thin film psilocybin product to become a potential novel treatment for various mental illnesses, neurological and substance abuse disorders,” said Revive Therapeutics CEO Michael Frank in the press release announcing the research results.

Oral thin films have become a popular way to deliver medications due to their versatility. They provide fast, local or systemic effects and can be easily applied by themselves—especially for dysphagia patients, geriatric, pediatric or bedridden patients, as well as those that cannot easily access water. The delivery mechanism also bypasses liver metabolism, enabling the delivery of more active ingredients to produce the desired effect with less toxicity.

Targeting Unique Regulatory Pathways

Revive Therapeutics aims to take advantage of regulatory incentives at the FDA, including Orphan Drug, Fast Track, Breakthrough Therapy, and Rare Pediatric Disease designations to rapidly advance drugs through clinical trials using its oral thin-film technology. For example, Orphan Drug designations provide tax credits worth 50% of the clinical drug testing costs and market exclusivity for seven years post-approval. 

After acquiring Psilocin Pharma Corp. and PharmaTher Inc.’s psilocybin program, the company gained access to IND-enabling research for traumatic brain injury and stroke, as well as FDA Orphan Drug qualifying research in neurological and cancer indications. In fact, on April 27, the company filed an application with the FDA for an Orphan Drug designation for traumatic brain injury, where there are no FDA-approved treatments.

The company has also developed a simple method to rapidly-produce psilocybin with E. coli in collaboration with NCSU, which could provide the raw materials for upcoming clinical trials, and eventually, help scale up manufacturing to meet patient demand.

Looking Ahead

The psychedelics industry is rapidly becoming one of the most promising subsets of the pharmaceutical and biopharmaceutical industry. While there are many companies developing clinical products, Revive Therapeutics Ltd. (CSE: RVV) (OTC: RVVTF) has developed a unique delivery technology and plans to target high-value FDA regulatory pathways to pave the way toward more efficacious products, cheaper clinical trials, and more market exclusivity.

Investors should keep an eye on the company given the completion of its research and the potential to advance its psilocybin programs into clinical trials near-term.

For more information, visit the company’s website or download their investor presentation.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

The psychedelics industry has experienced a renaissance over the past few years as researchers have opened a pandora’s box of potential. From major depression to generalized anxiety to post-traumatic stress disorder, emerging research suggests that psychedelic substances could have a significant beneficial impact on hard-to-treat mental health disorders.

As states liberalize their psychedelics regulations, microdosing has become a popular trend that could offer a variety of mental health benefits. Research on microdosing remains in its infancy, but the combination of placebo-controlled studies and effective delivery systems could translate to a larger-scale trend over the coming years.

Let’s take a closer look at microdosing and how new technologies are making it easier to achieve a consistent result.

What is Microdosing?

Microdosing is the practice of consuming a very low, sub-hallucinogenic dose of a psychedelic substance, such as psilocybin or LSD. While scientific literature contains minimal research, there is plenty of anecdotal evidence to support the practice but the handful of high-quality studies that do exist paint a mixed picture of microdosing efficacy.

In 2018, the Imperial College of London conducted the first placebo-controlled study of microdosing practices. Participants received either a psychedelic or placebo and completed online surveys and cognitive tasks at regular intervals. The results showed improvements in both the psychedelic and placebo groups with no significant differences between them.

Other researchers believe that microdosing may still offer tangible benefits. Maastricht University researchers in the Netherlands conducted their own small-scale placebo-controlled study and found beneficial effects on mood and attention for some participants that couldn’t be explained by the placebo effect. They suggest that timing could be an important factor.

The same researchers from Maastricht University measured brain-derived neurotrophic factor (BNDF)—a protein that affects brain plasticity—and found an increase a few hours after microdosing psychedelics in blood tests. These findings suggest that there is some kind of physiological factor at play with microdosing practices.

 Ensuring the Right Dose

The varying effects of microdosing practices could be the results of varying metabolic rates and drug delivery mechanisms. For instance, capsule-based forms of microdosing involve swallowing a pill that is subject to second-pass metabolism in the liver. Sublingual delivery mechanisms, on the other hand, quickly move to the brain. 

Revive Therapeutics Ltd. (CSE: RVV) is building an intellectual property portfolio around psychedelic drug delivery. After acquiring Psilocin Pharma Corp., the company partnered with Complete Phytochemical Solutions and signed a sponsored research deal with the University of Wisconsin-Madison to develop new delivery methods for psychedelic substances.

The company’s dissolvable oral strips could be especially beneficial for microdosing, delivering between one and 20 milligrams of natural or synthetic psilocybin with rapid onset that bypasses liver metabolism. The company’s other products targeting both psychedelics and cannabinoids include lozenges, gels, creams and transdermal patches. 

While many companies undergo expensive clinical trials, the company’s innovative delivery systems could see a faster path to commercialization as California, Oregon and other states start to legalize psychedelics for personal use. These efforts could open the door to widespread microdosing practices to realize cognitive and other mental health benefits.

Looking Ahead

Investors interested in the psychedelics space may want to consider companies focused on microdosing practices since they could represent a nearer-term path to commercialization. Revive Therapeutics Ltd. (CSE: RVV) (OTC: RVVTF) is a prime example with its dissolvable oral strip delivery system for psilocybin microdosing.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.