Revive Takes a Step Closer to Launching New Psychedelic Delivery Mechanism
April 30th, 2021
Psychedelics, Top News
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.
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.
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