Big News about Epidiolex

Big News about Epidiolex

In mid-March, British-based GW Pharmaceuticals made big news when it announced that its drug Epidiolex, a medication derived from the cannabis plant, reduced seizures in children suffering from Dravet Syndrome by 39 percent. GW Pharma will request approval of the Federal Drug Administration to market the drug in the U.S. As Justin Gover, GW’s Chief Executive Officer said,


The positive outcome of this Phase 3 trial is a significant milestone in the development of Epidiolex as a potential new treatment for patients suffering from Dravet syndrome. We are excited about the potential for Epidiolex to become the first FDA approved treatment option specifically for Dravet syndrome patients and their families.


Because Epidiolex is derived from marijuana, however, it will have to be de-scheduled or rescheduled as less than a Schedule I controlled substance before sales could begin. The U.S. Drug Enforcement Agency is not expected to oppose the move. With a Schedule II or III classification, Epidiolex could be on the shelves as early as 2017.


What just happened, here?


Did a British drug company just cut through the regulatory tangle that has hamstrung medical cannabis research and drug development in the U.S. for decades?


As always with cannabis, it’s complicated.


Parents and Investors are Happy


The availability of another promising option for children with treatment-resistant forms of epilepsy, even in addition to Dravet Syndrome, is surely good news for them and for their parents.


Investors have also taken note. On the day GW Pharma announced the results of its study, the stock price jumped 135.54 percent, hitting $90.59 by mid-day. By the end of March, the stock was trading in the $70 range, but still a healthy jump from pre-announcement levels.


It is also important to recall that GW Pharma operates in an international market. Although the U.S. segment might be considerable, it is hardly the whole story. The Australian state of New South Wales, for example, began to offer Epidiolex as part of a compassionate access scheme for children with severe forms of epilepsy during March.


Mixed Views from U.S. Cannabis


In the fledgling U.S. cannabis industry, however, not all see GW Pharma’s move as a good thing  — throwing wide the doors to research and development through de-scheduling or rescheduling.


It’s a hard question. It might be sour grapes; it might be an enlightened  view of what health means and what the potential for exploration is. It might be a struggle for cannabis culture.


Rescheduling cannabis-based drugs is actually nothing new. Marinol, a synthetic form of THC, is classified as a Schedule III drug, and has been available in the United States since 1985. Until now the FDA has maintained a distinction between synthetic and plant-based drugs.


It would be logical to assume that FDA’s approval of plant-based Epidiolex might finally put away the argument that cannabis should be classified as a Schedule I drug because it has no legitimate medical use.


However, GW Pharma has long positioned itself not as a medical marijuana company, but as a regular pharmaceutical company that happens to use compounds derived from the cannabis plant. It has opposed full legalization because of the potential for negative impact on its share price, even going so far as to hire a high-profile marijuana critic to help it distinguish its products from medical marijuana. The profitability of drugs like Epidiolex may depend, at least in part, on continued barriers to medical marijuana research under federal law.


Nowhere was the competition for government funding more obvious than in the decision by the Florida Department of Health to use its earmarked CBD research funds to test Epidiolex rather than raw CBD oils like Charlotte’s Web.


Many insist that the benefits of cannabis are greater when the various endocannabinoids present in the whole plant are available, not in the isolation produced through FDA research. Others see great potential for cannabis as a wellness product even beyond its role as in curing or treating disease.


Still others fear the power of Big Pharma and see the FDA’s apparent new openness as no less than cultural hijacking.


Some believe Uncle Sam has embraced GW Pharmaceuticals because the drug company has the necessary capital needed to obtain FDA approval, while others argue a corporate version of legal marijuana is simply easier for the feds to understand because it is packaged with familiarity – corporations led by crisp haircuts and Armani suits, not dreadlocks and tie-dyed T-shirts.


For these and others, the issue is the future of marijuana culture. What’s the story with Epidiolex? It clearly depends on who you ask, but there is no reason to choose one answer to the exclusion of all others.