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Pharma Tech Outlook | Tuesday, March 31, 2020
Real Brands enters the medical psychedelics market, forms partnerships with Marcu & Arora for licensure and research and development.
FREMONT, CA: The pharmaceutical industry covers the production, preparation, and marketing of medications and its growth is heavily dependent on research and development (R&D). This sector is continually forced to rethink its business models to maximize revenue from patents and optimize medication development; investing in R&D is critical to avoiding obsolescence in a highly competitive market. Real Brands, a multi-brand owner, formulator, extractor, and manufacturer of branded hemp-derived CBD products, is embarking on a growth strategy to establish itself as a leading provider of medicinal psychedelics. In Phase I of establishing a foothold in the medical psychedelics market, Real Brands has partnered with consulting firm Marcu & Arora to apply for psychedelics licensure with the United States Drug Enforcement Agency (DEA), including defining the application protocols and the focus of formulation R&D. Additionally, Real Brands has applied to the DEA for authorization to process and handle hallucinogenic chemicals, and the state of Rhode Island for authorization to prescribe, dispense store, and ship prohibited narcotics.
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“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,” states 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.”
Previously, federal agencies disallowed research on psychedelics due to their Schedule I classification. Federal authorities are currently working on permitting the restricted manufacture of certain Schedule I drugs to expand 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," states 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 creating a range of psychedelic formulations, including low- or micro-dosage delivery forms. Microdosing is consuming shallow doses of a psychedelic chemical, such as lysergic acid diethylamide (LSD) or psilocybins that are not hallucinogenic—found in some mushrooms. A few research publications and a plethora of anecdotal anecdotes indicate that a diverse group of people has benefited from enhanced creativity and a greater sense of enjoyment in the treatment of PTSD, anxiety, addiction recovery, and depression. Real Brands will investigate psychedelic-assisted medicines based on naturally occurring substances such as psilocybin, mescaline, and N,Ndimethyltryptamine used by Indigenous peoples for millennia.
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