FDA Approves Marketing Of Plant-Derived Marijuana Medicine


Years ago, the Stanley brothers of southern Colorado grew a strain of marijuana low in THC and high in CBD.

Aside from Epidiolex, GW Pharma also sells Sativex-which includes components of marijuana-in 30 countries as a treatment for multiple sclerosis-related spasticity.

Several researchers are studying the potential of CBD to treat psychiatric conditions.

The FDA news signals that the DEA will likely adjust its scheduling for CBD, which is now a Schedule I substance, denoting high potential for abuse and no medical applications. The drug, Epidiolex, was developed by British biotechnology company GW Pharmaceuticals to treat two rare forms of severe epilepsy - Dravet syndrome and Lennox-Gastaut syndrome. It is the fourth marijuana-based medicine to receive US FDA approval - joining dronabinol (aka Marinol), nabilone (aka Cesamet), and liquid synthetic THC (aka Syndros).

As a result, Epidiolex's launch remains at the discretion of the DEA which must now evaluate the drug and consider reclassifying it as a substance that has medical properties, which would allow GW to begin selling it. It is given as an oil, and in clinical trials, it was shown to reduce the number of seizures by about 40 percent in patients with Dravet or Lennox-Gastaut syndromes.

Side effects included sleepiness, sedation, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, weakness, insomnia, poor quality sleep and infections.

"We anticipated that Epidiolex will be the first of many potential FDA-approved medicines based on the cannabis plant", Armentano continued.

The drug contains cannabidiol, or CBD, a substance derived from marijuana, but causes no intoxication, euphoria or "high", the FDA said.

Epidiolex's effectiveness was studied in three randomized clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome, comparing Epidiolex to a placebo. Gover said the green light signifies that his company's recent efforts in developing more drugs from marijuana's compounds (also known as cannabinoids) finally have a concrete path forward.

For medical marijuana advocates, it's a clear vindication of a fundamental premise of a decadeslong movement: that cannabis can have legitimate medical applications and it isn't the bogeyman that the federal government has long made it out to be. FDA Commissioner Scott Gottlieb further added: "This is the approval of one specific CBD medication for a specific use".

The FDA is not required to follow the advisory panel's advice but usually does.

For their part, GW Pharmaceuticals executives say they are not trying to disrupt products already on the market. The agency is expected to make this classification within 90 days. Agency officials paved the way for the cannabis-based drug by defending its effects in a briefing document, writing, "In general, the risks associated with CBD treatment appear acceptable, particularly given the findings of clinical efficacy in LGS and DS, which are serious, debilitating, and life-threatening disorders".

The FDA's first approval of a cannabis-derived compound happened thanks to sound science, and it must proceed that way.