Cannabinoid drugs are already in late-stage development in the U.S., with some on the cusp of FDA approval. As a California-based company operating within this industry, which is regulated by the FDA and DEA, we recognize that regulatory changes are likely to occur, especially in an election year. I’ll describe briefly what is likely to change next Tuesday on Election Day, then look at how it will impact our company as well the ability of patients and physicians to access treatment.
First of all, it’s clear the trend towards state legalization is continuing. There are five additional states that have legalization on the ballot, including the nation’s most populous, California. Our state may approve recreational marijuana, and this could represent a tipping point nationwide. Secondly, of course the actions of a new President could alter the drug development landscape as well, but more on that later.
When legalization occurs in a state, it can become a hotbed of clinical research. The state of Colorado for instance has funded $9 million in clinical trials of cannabinoids, including the CANDID trial, a study of the effects of cannabis on 160 pediatric inflammatory bowel disease (“IBD”) patients. As a result, new data on the safety and efficacy of cannabinoids emerges, which can really help pharma companies like us that are delivering targeted effects in pill form. Medical marijuana acts as a proxy for cannabinoid drugs, and so this emerging data can help guide us towards rapid approval of effective cannabinoid medicines. In cases like ours, at Vitality Biopharma, where we’re also developing a site-specific pharmaceutical, it also means that any therapeutic effects that can be attained with medical marijuana, we could amplify and do even better. So, for us, in short, the more legalization the better.
When it’s approved for recreational use, as is being considered in California, clinical use becomes even easier because all friction is removed for patients that wish to obtain these medications. California is a state that is 7 times larger than Colorado, so instead of 160 IBD patients experimenting with cannabinoids as a treatment, it’s not hard to imagine hundreds or even thousands of patients in California could soon be doing the same.
The interest and excitement that is occurring within the IBD community with cannabinoids is very similar to what occurred over the last several years with pediatric epilepsy. Early reports from those states which legalized medical marijuana led to a dramatic reevaluation by the medical community about the utility of CBD for epilepsy. The therapeutic results became impossible to ignore when it was being used to treat kids with drug-resistant seizures, a devastating condition where there are no other alternatives. There was initial skepticism about these early success stories, but it quickly faded away when the results were replicated in large, randomized clinical trials. Now, here we are, where a company is on the cusp of drug approval for this indication, and FDA-approved CBD could become available for the first time.
As I’ve noted previously, widespread testing of cannabinoids will also enable new treatments for prevention of opiate abuse and treatment of opiate addiction. Initial results indicate that cannabinoids could help both reduce opiate use in the first place, and also provide treatment for withdrawal and preventing relapse. So as a company our discovery work in this area is geared towards identifying how cannabinoids can be best applied to this epidemic, and how these benefits can be delivered in pill form.
Turning back to the presidential election, a choice between two tough-on-drug candidates means that no matter who wins it isn’t likely that the regulatory power of the DEA or FDA will erode significantly. As a result, at the federal level, it appears an FDA-approved pharmaceutical will remain the only legal way to deliver the therapeutic benefits of cannabinoids nationwide. We don’t have any issue with this approach (our team is built for the task), and we simply hope we can continue to move ahead quickly.
One significant impact of Hillary Clinton’s election would be an acceleration of new treatments for opiate addiction. She’s already announced a $10 billion initiative, and her family foundation has a track record on this issue, as they’ve been funding efforts to curb prescription drug abuse through the Clinton Health Matters Initiative. Given that no clear solutions exists currently, and that cannabinoids represent a promising alternative, you’re likely to hear much more about this in late 2016 and into 2017.
Robert Brooke, CEO