Cannabis-Based Drug Companies Hopeful Epidiolex Will Pave the Way for Future Approvals
Following the U.S. Drug Enforcement Agency’s rescheduling of GW Pharmaceuticals' Epidiolex from a Schedule I to a Schedule V, other cannabis-based drug development companies believe there is momentum for their medications to gain regulatory approval.
In June the U.S. Food and Drug Administration (FDA) approved Epidiolex as a treatment for seizures associated with two rare forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome. The approval of Epidiolex marked the first time the FDA approved a drug that contains a purified drug substance derived from marijuana.
This morning Las Vegas-based GB Sciences, Inc. said the rescheduling and approval of Epidiolex “validates the commercial potential” of the company’s assets. Like U.K.-based GW Pharmaceuticals, GB Sciences is developing cannabinoid therapies for a number of medical conditions. GB’s lead asset is focused on Parkinson’s disease. GB Sciences noted that a significant consequence of the DEA’s rescheduling of Epidiolex, a treatment for a rare form of epilepsy, established that Epidiolex can be distributed to patients through standard pharmaceutical channels. That means, the company said, it will be easier for future cannabis-based medicines to get to patients should they pass regulatory muster.
Despite the DEA’s rescheduling of Epidiolex, other non-FDA-approved CBD preparations remain in Schedule I. That is a sore point for some other CBD drugmakers like GB Sciences.
John Poss, chief executive officer of GB Sciences said GB Sciences is not a “cannabis company that dabbles in science,” rather it is a “biopharmaceutical company that happens to grow cannabis.”
“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,” Poss said in a statement.
The hope for GW Pharma’s medication to pave the way for future CBD drugs to gain approval comes days after GB Sciences struck a deal with U.K.-based Catalent Pharma Solutions to provide oral delivery systems, formulation development, and clinical-scale oral dose manufacturing of GB Sciences’ CBD treatments, GBS101, GBS102, and GBS103, for Parkinson’s disease. The company’s assets are complex mixtures containing up to nine cannabinoid-containing complex mixtures. It’s that combination of components that the company said are “more potent than would have been predicted by combining the activity of each individual compound.”
Andrea Small-Howard, chief science officer of GB Sciences, said she was hopeful about the rescheduling of CBD medications to Schedule V, particularly in light of the announcement that Catalent will be formulating the cannabis-based Parkinson's disease formulations in preparation for the company’s planned exploratory investigational new drug-filing
"This may be the best time in history to be developing cannabis-based medicines,” Small-Howard said in a statement.
To date, GB Sciences said it has filed four patent applications for its cannabinoid-containing complex mixtures for use in four disease categories: neurodegenerative disorders, cardiovascular diseases, inflammatory disorders, and chronic and neuropathic pain. The company said more than 60 potential medical conditions can be addressed by its cannabis-based formulations. CBD is a therapeutic component in about 20 percent of these formulations, the company said. Additionally, the company noted that less than 10 percent of its formulations contain delta-nine tetrahydrocannabinol (THC), the psychoactive component of cannabis.