Aug
1
2018

The US Food and Drug Administration (FDA) gave veterinarians the green light to use cannabis in the treatment of pets—in a manner of speaking.

Put it this way: It didn’t say they couldn’t.

Here’s what happened: Last month, the FDA took the groundbreaking step of approving a prescription drug that includes an active ingredient found in the Cannabis sativa plant (a.k.a. marijuana), to treat certain conditions in people . The active ingredient is cannabidiol, typically called CBD.

The new prescription drug, named Epidiolex, is labeled for use in human patients to treat two forms of rare, severe epilepsy: Dravet syndrome and Lennox-Gastaut syndrome.

But what about using Epidiolex to treat, say, epilepsy in dogs?

That’s where things get tricky.

The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) authorizes extralabel use of human drugs in veterinary medicine. It means the FDA can restrict extralabel use (sometimes called offlabel use) of specific drugs in animals. It has not, however, restricted Epidiolex.

So does that mean Epidiolex is fair game? NEWStat reached out to the FDA for clarification.

FDA spokesperson Siobhan DeLancey, RVT, MPH, confirmed for NEWStat that “the FDA has placed no restrictions on extralabel use of Epidiolex in animals.” She did caution that, “Veterinarians must follow the principles discussed in AMDUCA, as well as any state and federal regulations for the handling of the drug.”

Does that mean veterinarians can use Epidiolex as an extralabel drug in veterinary patients?

Not quite yet.

There are at least two stumbling blocks: First, before Epidiolex is cleared for sale in the United States, the US Drug Enforcement Agency (DEA) has to review it and, more importantly, classify it. Right now the drug is technically illegal because the DEA considers CBD a Schedule I drug. According to the DEA, a Schedule I drug “ha[s] no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.” The DEA has 90 days from the date of FDA approval to change the Schedule I designation, although at this point in the approval process the Schedule change is pretty much a formality.

And second, nobody even knows if Epidiolex will do dogs any good.

Research is ongoing. The work of Stephanie McGrath, DVM, MS, DAVCIM (Neurology), an assistant professor at the Colorado State University College of Veterinary Medicine and Biomedical Sciences, is especially promising. Her research into the efficacy of CBD in dogs with epilepsy found that 89% of dogs who received CBD in a clinical trial had a reduction in the frequency of seizures (Learn more about the current state of Cannabis research, including more about McGrath’s work, in this article from the May 2018 issue of Trends magazine).  

Whether Epidiolex can make a difference remains to be seen. And until the DEA makes its ruling, Epidiolex as an option for the treatment of epilepsy in dogs isn’t just offlabel, it’s off the table.

Photo credit: © iStock/Monica Click

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