DEA rescheduling of Epidiolex to Schedule V establishes commercial viability for cannabis-based formulations
LAS VEGAS, Oct. 2, 2018 /PRNewswire/ -- GB Sciences, Inc.
(OTCQB: GBLX) has gained momentum in its innovative drug discovery program with the Drug Enforcement Administration (DEA)'s
decision to reschedule GW Pharmaceuticals' Epidiolex, from Schedule I to Schedule V of the Controlled Substances Act (CSA).
In June of 2018, Epidiolex was the first ever plant-based, cannabis drug to be approved by the Food and Drug Administration
(FDA). There is now both a regulatory precedent for market approval on a plant-based cannabinoid-containing drug and a path to
its commercialization. The new DEA rescheduling establishes that products containing cannabidiol (CBD) that are approved by the
FDA can now be rescheduled to the lowest rating a drug can receive based on their approved medical use and low potential for
abuse. However, the most significant consequence of the DEA rescheduling is that Epidiolex can now be distributed through
standard pharmaceutical channels to patients based on a doctor's prescription. The odds of successful commercialization of
cannabis-based therapeutics have now been greatly increased, not only in the US, but given the stature of the US FDA, across the
globe.
The DEA rescheduling of Epidiolex validates the commercial potential of the Company's research program focused on creating
cannabis-based medical formulations containing complex mixtures of cannabinoids and terpenoids. To date, the Company has filed
four patent applications protecting disease-specific, cannabinoid-containing complex mixtures (CCCM™) for use in four disease
categories: neurodegenerative disorders, cardiovascular diseases, inflammatory disorders, and chronic and neuropathic pain.
Within each patent application family, there are dozens of CCCM™ claimed. In total, over sixty potential medical conditions
are addressed by GB Sciences' disease-specific CCCM™. CBD is a therapeutic component in about 20% of these formulations.
Fewer than 10% of GB Sciences' patent-pending formulations contain delta-nine tetrahydrocannabinol (THC), the psychoactive
component of cannabis. GB Sciences' intellectual property portfolio currently describes and claims many
pharmaceutically active CCCM™ that, subject to successful clinical trials in the future, could one day be eligible for FDA
approvals.
"I am very hopeful about the rescheduling of FDA-approved CBD to Schedule V, especially coming on the heels of our
announcement that Catalent will be formulating our cannabis-based Parkinson's disease formulations in preparation for our planned
Exploratory IND-filing and Phase 0 human clinical trial," explained Dr. Andrea Small-Howard,
Chief Science Officer of GB Sciences. "This may be the best time in history to be developing cannabis-based
medicines!"
In an analyst's report by a respected investment banking firm, it was stated that, "Companies that pursue robust medical
and clinical cannabis strategies will distinguish themselves not only in clinical applications of cannabis, but also in the
forthcoming adult-use cannabis market. Therefore, companies developing FDA-regulated products will be less susceptible to the
vagaries of the recreational market, command higher prices and margins, drive strong adoption, and access not only the massive
U.S. market, but much larger global markets as well."
"The DEA rescheduling is significant for our company because we are not a Cannabis company that dabbles in science, we are
a biopharmaceutical company that happens to grow Cannabis," said John Poss, CEO and Chairman
of GB Sciences. "Although the recent ruling by the DEA is a positive development, it falls short of giving researchers the
tools required to rapidly advance cannabis-based drug research and development. The US remains one of the most hostile
environments in the world in which to strive to make cannabis-based drugs available to the patients who need them, and the US FDA
sets the tone for international harmonized regulatory standards."
About GB Sciences, Inc.
GB Sciences, Inc. (OTCQB: GBLX) is a diverse cannabis company, focused on standardized cultivation and production methods; as
well as biopharmaceutical research and development. The Company's goal is creating safe, standardized, pharmaceutical-grade,
cannabinoid therapies that target a variety of medical conditions. To learn more about GB Sciences, Inc., go to: http://gbsciences.com.
Forward-Looking Statements
This press release may contain statements relating to future results or events, which are forward-looking statements.
Words such as "expects", "intends", "plans", "may", "could", "should", "anticipates", "likely", "believes" and words of similar
import may identify forward-looking statements. These statements are not historical facts, but instead represent only the
Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's
control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the
anticipated results and financial condition indicated in these forward-looking statements. Further, information concerning
the Company and its business, including factors that potentially could materially affect the Company's business and financial and
other results, are contained in the Company's filings with the Securities and Exchange Commission, available at www.sec.gov. All forward-looking statements included in this press release are made
only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any
forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.
Note: Although the Company's research and development activities are not illegal, the production and sale of cannabis
products violate federal laws as they presently exist.
Contact Information
Corporate:
GB Sciences, Inc., 3550 West Teco Ave., Las Vegas, NV 89118
866-721-0297, or
Tom Arcuragi, EVP, tom@gbsciences.com
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SOURCE GB Sciences, Inc.