FDA Briefing Hints at First U.S. Government-Approved Marijuana-Derived Drug

Medical marijuana advocates and patients sing the plant’s praises for its ability to help people who live with PTSD, opioid dependency, and even seizures. And while the whole plant, as well as its main active chemicals, Δ⁹-tetrahydrocannabinol (THC) and cannabidiol (CBD), have shown healing potential, there aren’t any U.S. Food and Drug Adminstration-approved uses for marijuana or marijuana-derived drugs. A new report from the organization, however, suggests that may change very soon, though.

According to a briefing circulated in advance of the Thursday meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee, GW Pharmaceuticals is seeking approval for a cannabidiol drug to treat two rare seizure disorders in children, Lennox-Gastaut syndrome and Dravet syndrome. If the committee approves the drug, it will be the first marijuana-derived drug to ever receive FDA approval. The overwhelmingly positive briefing suggests that the odds of approval are high — and investors are betting on the FDA’s decision, as GW Pharmaceuticals’ stock surged on Tuesday.

Even though clinical trials demonstrated CBD’s effectiveness in treating these seizure disorders, two obstacles to approval remained: concerns over toxicity and abuse potential. Regarding liver toxicity, the FDA briefing indicates that “Although the risk of liver injury has the potential to be serious, the observed risk can be appropriately managed.” The issue of abuse is a little more sticky, as marijuana’s current legal status — Schedule I — states that it has high abuse potential and no medical potential.

But CBD, just one of many cannabinoids in marijuana, is minimally psychoactive, so the FDA briefing indicates that this shouldn’t be an issue. Still, federal law regarding marijuana derivatives has kept CBD products in a grey market. While the U.S. has patchwork state-by-state cannabis laws, it’s still illegal under federal law. But the FDA, a federal body, has examined the evidence available for CBD use and “concluded that CBD has a negligible abuse potential.” And overall the conclusions seem quite positive.

“Although the review is still ongoing, the risk-benefit profile established by the data in the application appears to support approval of cannabidiol for the treatment of seizures associated with [Lennox-Gastaut syndrome] and [Dravet syndrome],” reads the committee briefing. The meeting on Thursday should shed some light on the U.S.’s first marijuana-derived drug.

If GW Pharmaceuticals gets approval to sell a cannabidiol medication, it will set a new precedent for the pharmaceutical industry’s role in the medical marijuana movement. And while a dominant strain among medical marijuana advocates is a distrust of big pharma, sometimes it seems that the deep pockets necessary to run clinical trials can get the job done.