Norfolk firm to use cannabidiol for medical research
In May, Nofolk-based Sanyal Biotechnology became one of few U.S. companies to receive licensing to import cannabidiol (CBD) for medical research and clinical trials.
CBD is an oil extracted from hemp or marijuana. It also can be synthesized in a laboratory. Under the license, Sanyal also can import tetrahydrocannabinol (THC), a marijuana extract that has some medical benefits but also is the mind-altering component of cannabis.
Sanyal, which was spun out of Virginia Commonwealth University in 2015, applied for the license after being asked by Ontario-based Revive Therapeutics to use CBD to conduct research on obesity and NASH (the most severe form of non-alcoholic fatty liver disease). “We never anticipated getting into this industry. The company found us,” says Rebecca Caffrey, Sanyal’s CEO.
Drugs falling under Schedule 1 classification of the U.S. Controlled Substances Act are illegal. They include heroin, LSD and marijuana. The federal government scrutinizes Schedule 1 licensing applications to prevent the import and sale of products for illegal purposes.
The licensing process with the Virginia Board of Pharmacy and the U.S. Drug Enforcement Agency took a year to complete. “It’s nearly impossible to get a license,” says Caffrey. “We got the broadest license available.”
Interest from researchers and physicians conducting clinical trials with CBD has increased since June when the FDA approved the drug Epidiolex, which contains pure CBD. The drug, produced by GW Pharmaceuticals, will be used to treat seizures in patients with rare, severe forms of epilepsy.
The FDA’s decision has set up a difficult decision for the government. “This has forced the hands of the federal government,” says Caffrey. “They have to determine if they reschedule marijuana.”
The DEA has “90 days to schedule Epidiolex as a Schedule 2, 3, 4 or 5 drug or not schedule it at all. We are in the process of looking into this,” says DEA spokesman Wade Sparks. “That does not mean it will be a sweeping reschedule of CBD or marijuana as a whole. CBD could stay Schedule 1. It could come out a total reschedule of the ingredient but it doesn’t have to be. All that is being determined by the DEA.”
Caffrey is talking to physicians in other states about the potential use of CBD properties to treat attention deficit disorder, headaches, depression, anxiety, sleep disorders and post-traumatic stress disorder. “Before we couldn’t get the drugs to do clinical trials,” she says. “We are bringing a piece of the puzzle that no one has had before.”
This type of research represents a growing area in the medical field. In February, the Virginia Senate and House of Delegates passed HB 125, allowing the use of CBD oil or THC-A oil to help alleviate the symptoms of diagnosed conditions or diseases. Gov. Ralph Northam signed the bill in March.
“This is a challenging environment. Everything changes on a daily basis,” Caffrey says. “It’s like working on roller skates in a greased rink that is on fire.”