Pharma Focus Asia

GB Sciences' Drug Development Program Benefits from Establishment of Clear Pathway for Cannabis-Based Drug Approvals and Commercialization

Wednesday, October 03, 2018

GB Sciences, Inc. 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."

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