- Real Brands applying for DEA psychedelics licensure
- Psychedelics drugs market size is projected to reach $10.75 billion by 2027
- Real Brands planning to leverage new clinical research to produce and deliver safe, nature-based psychedelics product formulations that will effectively treat mental health conditions
North Providence, RI, March 24, 2022 (GLOBE NEWSWIRE) — Real Brands Inc. (OTCQB: RLBD), a multi-brand owner, formulator, extractor and manufacturer of branded hemp-derived CBD products, is initiating expansion to become a premier provider of medical psychedelics. As Phase 1 of laying the groundwork for entry into the medical psychedelics market, Real Brands has entered a partnership with consulting firm Marcu & Arora to apply for U.S. Drug Enforcement Agency (DEA) licensure for psychedelics, including defining the protocols for application and the focus of the formulation research and development. Additionally, Real Brands will apply to the DEA for authorization to process and handle psychedelic substances, and it has applied to the state of Rhode Island to be able to prescribe, dispense, store and ship controlled substances.
“We are pursuing research and development of medical psychedelics because current traditional mental health care treatments are often ineffective and have severe negative side effects,” stated Thom Kidrin, CEO of Real Brands. “Revolutionary breakthroughs in medicine, pharmacology, and behavioral neuroscience have exposed the vast potential of psychedelics and empathogenic drugs as highly effective therapies. We have engaged Marcu & Arora to help us navigate the complicated process of DEA licensure for research on psychedelics, the protocols for application and all aspects of formulation R&D. We hope to become the first in Rhode Island to secure a license.”
Kidrin noted, “Dr. Jahan Marcu and Dr. Nigam B. Arora are two of the most knowledgeable experts in the fledgling psychedelics industry. With a combined 30+ years of experience in chemistry, pharmacology, research, communications, government relations, advocacy, and entrepreneurship, we believe their ability to navigate the federal regulatory and research environments are unparalleled. Additionally, Marcu & Arora’s network of PhD scientists, medical doctors, attorneys, standards experts and venture capital firms specializing in these areas provides us with additional resources we can tap to efficiently build our psychedelics business with the highest standards.”
Previously, research on psychedelics has been prohibited by federal agencies due to their classification as Schedule I substances. The federal agencies are now in the process of allowing controlled production of certain Schedule I substances for the purpose of expanded research.
“Fortunately, federal agencies have recently begun to acknowledge the results of the limited studies that have been done and the larger body of anecdotal evidence that indicates psychedelics show promise for treatment of certain medical conditions such as depression, PTSD and traumatic brain injury,” stated Jahan Marcu, PhD, Founding Partner at Marcu & Arora. “We believe Real Brands can successfully navigate the licensure process for research into Schedule 1 substances. The study concepts that Real Brands is pursuing will have the potential to become game-changing solutions for entheogen-based treatment of certain mental health conditions with minimal risk.”
Real Brands is developing a variety of formulations for psychedelics, including administration forms with low dosing or ‘micro-dosing.’ Microdosing is the practice of consuming very low, sub-hallucinogenic doses of a psychedelic substance, such as lysergic acid diethylamide (LSD) or psilocybin (found in some mushrooms). There are a few scholarly articles and a wealth of anecdotal stories reporting that a wide cross section of people have experienced benefits in the treatment of PTSD, anxiety, addiction recover, depression, and have experience increased creativity and improved sense of happiness. Real Brands will be exploring psychedelics-assisted therapies, based on compounds such as psilocybin, mescaline and N,Ndimethyltryptamine, which are found in nature and have been used by Indigenous populations for millennia.
“Just as there has been a sea change in the research and acceptance of cannabis for medicinal purposes, we believe that psychedelics are the next wave of pharmaceuticals primed to be developed,” Kidrin remarked. “Amidst unprecedented societal challenges associated with overlapping crises in mental health and a strained healthcare system, we find ourselves on the precipice of profound change. This previously untapped and under-researched class of medicinal drugs is the center of a developmental renaissance where client-centered, evidence-based interventions are urgently sought after by patients and providers as well as institutional and governmental stakeholders. Real Brands is positioning itself to leverage the new clinical research and the opportunity before us, to produce and deliver safe, nature-based product formulations that will effectively treat mental health conditions.
Research firm Research And Markets projects that the Psychedelic Drugs Market size is projected to reach USD $10.75 Billion by 2027, from USD $4.75 Billion in 2020 growing at a CAGR of 12.36% during 2021-2027. Fairfield Market Research has stated traditional drug treatments and therapies are not effectively combatting the mental health crisis. Fairfield argues that psychedelic substances could see a boost in demand in the coming years. “These statistics put together [about mental health rates] are expected to generate a demand for psychedelic drugs as diagnosis, therapy, and mental health awareness programs gain emphasis at individual and institutional levels.”
The positive results of various clinical trials with psychedelics have been coupled with a large amount of capital investment into psychedelics biotech companies. As more companies are seeing the potential of psychedelics to treat mental health issues, the field expands.
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About Real Brands Inc.
Real Brands is a multi-brand owner, formulator, extractor and manufacturer of branded hemp-derived CBD products to improve targeted areas of health and wellness for athletes, consumers and pets. Real Brands is the result of a 2020 merger with Canadian American Standard Hemp Inc. (CASH) that brought together Industrial-scale hemp CBD oil/isolate extraction and processing, wholesaling of CBD oils and isolate, and production and sales of numerous hemp-derived CBD consumer brands of smokable, edible and topical products. Its Halo 5 proprietary chromatography extraction technology mass produces highly purified material and precise pharmaceutical grade molecular separation at dramatically reduced costs resulting in more affordable precisely formulated products. Visit https://realbrands.com/. Consumer product lines are available on www.phazesports.com, www.wabrands.com, and www.americanstandardhemp.com.
This release contains certain forward-looking statements and information relating to Real Brands, Inc. (the “Company”) that are based on the current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, the Company. Such statements reflect the current views of the Company with respect to future events and are subject to certain assumptions, including those described in this release. Should one or more of these underlying assumptions prove incorrect, actual results may vary materially from those described herein as “should,” “could,” “will,” “anticipate,” “believe,” “intend,” “plan,” “might,” “potentially” “targeting” or “expect.” Additional factors that could also cause actual results to differ materially relate to the global COVID-19 crisis and other risk factors described in our public filings. The Company does not intend to update these forward-looking statements. The content of the websites referenced above are not incorporated herein.