In June, Colorado State University-Pueblo hosted Clayton Snell, a pharmacist at Greenwich Biosciences, to discuss the company’s work on epilepsy and developing cannabis plant-derived products to be approved by the US Food and Drug Administration.
Snell focused his presentation on the path to FDA-approval for Epidiolex, a cannabidiol-based medicine, which in 2018 became the first product derived directly from cannabis plants to obtain approval from the FDA. The approval was granted to treat the seizures associated with syndromes Dravet and Lennox-Gastaut, or Tuberous sclerosis, a rare condition that results in the development of many, often benign, tumors.
The approval process for Epidiolex was more complicated than for many other medicines because cannabis remains in the strictest category of the Controlled Substances Act, Schedule I. And, it was years in the making. In 2014, the FDA fast-tracked the company’s clinical trials after strong interest from families and lawmakers to make CBD-based products available to children with intractable forms of epilepsy, or seizures that generally do not respond to other medications. Families of sick children living in states without legal access to CBD were traveling or relocating to states like Colorado to obtain CBD-rich oil. It was clear at the time that sentiments around cannabis-derived medicines were evolving, too: In 2015, Nora Volkow, the director of the National Institute on Drug Abuse, wrote a blog post called “Researching Marijuana for Therapeutic Purposes: The Potential Promise of Cannabidiol (CBD).” And, just days before the FDA approval, the World Health Organization (WHO) Critical Review Report on cannabidiol (CBD) found that CBD “exhibits no effects indicative of any abuse or dependence potential.”
Snell covered four clinical trials: two that covered Lennox-Gastaut syndrome, published in 2018; one on Dravet syndrome, published in 2017; and one on tuberous sclerosis, published in 2020. Most patients who participated in these studies were 17 or younger, with some outliers. Broadly, these studies showed a reduction in seizures that was “statistically significant versus placebo.”
While these studies had similarities and differences, there were specific data points that had particular significance, including adverse events, total seizure frequency reduction, the proportion of patients in the treatment group that “achieved a reduction” of 50 percent or more, and the “patient and caregiver global impression of change at the end of treatment,” Snell said.
In other words, Snell continued, “Since they started this therapy, how has the therapy affected the patient or yourself?”
Snell laid out some of the warnings associated with taking Epidiolex from potential for liver injury in very high doses to drowsiness. Additionally, people who are pregnant should take Epidiolex only if doing so “outweighs the benefits and risks to the fetus.” And, people who are pregnant and on Epidiolex are being encouraged, Snell said, to enroll in the North American Antiepileptic Drug Pregnancy Registry so that data can be recorded.
The FDA has been on a mission to collect data about CBD since shortly after the 2018 Farm Bill legalized hemp, defined as cannabis plants with .3% THC or less, which is abundant in CBD. It is now up to the FDA to craft rules for non-medicine CBD products, which can already be found on the shelves of mainstream stores from coast-to-coast. Further complicating the FDA’s task in developing these rules is its approval of Epidiolex, as a product that has been approved as a medicine — in this case, CBD — cannot be allowed in, say, foods.
GW Pharmaceuticals, parent company of Greenwich Biosciences, has other cannabis-derived products, too. Nabiximols, the company’s oral spray product, which contains both THC and CBD, as well as “minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides,” is moving through the FDA channels for approval for “treatment of MS spasticity.” That product is known as Sativex outside of the US, and is already approved in some countries for multiple sclerosis.
Greenwich Biosciences has the largest cannabis-related lobbying footprint in the United States. The company has registered to lobby in every single state in the country—including ones where all forms of cannabis are prohibited—and at the federal level, as Cannabis Wire was the first to report.
Cannabis Wire asked the company in 2019 why it registered in so many states.
Stephen Schultz, then the company’s vice president of investor relations, said that the registrations were to ensure two things: one, that Epidiolex is available to patients in every state, and two, that the company’s other products quickly reach patients, should they also be approved by the FDA.
“Greenwich’s Government Affairs Team engages and actively lobbies in any jurisdiction in which there are challenges that would impede or delay access to our FDA approved medications for appropriate patients,” Schultz told Cannabis Wire in an email at the time. “We are similarly seeking to ensure that our investigational product, Sativex, will be rapidly available to patients in the states if and when it is approved by FDA and rescheduled by DEA.”
