FDA Approves Epidiolex, the U.S.’s First Cannabis Drug

Cannabis research is a tricky subject even in academic circles because the federal government still classifies marijuana as a Schedule 1 drug. The few labs that do with the substance are limited to a small number of strains grown in a single lab, making it difficult for researchers to determine the usefulness and efficacy of different strains.

This is why the FDA approval of a new cannabis drug, known as Epidiolex, is so exciting — it could both open the door for more cannabis research and make it easier for those who need marijuana or related products to obtain it.

Epidiolex and Epilepsy

Epidiolex is the first drug of its kind on the market — a medication derived from marijuana cannabinoids the FDA has approved to treat two rare types of epilepsy. It is derived from the non-psychoactive cannabidiol (CBD), a natural component found in marijuana. CBD doesn’t provide the high most recreational users are seeking — that effect comes mostly from the tetrahydrocannabinol (THC) in the plant.

Epidiolex has been approved to treat two different types of epilepsy, but we still have a few hoops to jump through before we can actually sell and use it in the U.S. The fact that this drug is derived from CBD means it still falls under the same federal Schedule 1 classification that all cannabis products fall under.

Although the FDA approved it, the DEA will have to reclassify CBD away from Schedule 1 or even reclassify the entire marijuana plant — though that is unlikely given the current state of the presidential administration, as well as the Attorney General’s abject hatred of marijuana.

Cannabis and Cancer

While the FDA has only approved Epidiolex for use in epilepsy treatments, it’s source material is being studied as a tool for treating a variety of other different medical conditions.

While there is a lack of published studies in the United States about the effects of cannabis on cancer cells, many exist in other countries that state cannabis can help reverse the effects of cancer. These studies also note marijuana can improve cancer patients’ quality of life by helping them manage the side effects and symptoms that come with both cancer and the harsh chemicals used to treat it.

Alternate Cannabinoids

One way for Epidiolex to get around the Schedule 1 restriction would be to source the drug’s cannabinoids from a plant other than cannabis. Three different types of cannabinoids to choose from include:

• Synthetic: These cannabinoids are produced in a lab. They’re not as effective as the natural alternatives, but they aren’t as restricted.
• Phytocannabinoids: These cannabinoids are produced naturally in plants — namely the cannabis plant, though there are others that also contain similar chemicals and bind to the same receptors in the brain.
• Endocannabinoids: These cannabinoids are produced naturally in the body.

By sourcing the CBD for Epidiolex from another plant that isn’t classified as a Schedule 1 drug, the FDA could get the drug on the market faster.

Medical Marijuana and Alternatives

The qualifying medical conditions that allow a patient to obtain a medical marijuana prescription are limited and vary dramatically from state to state. Some states also allow doctors to prescribe medical marijuana for any chronic condition they believe could benefit from it, especially if standard treatments are proving insufficient. Meanwhile, others still ban medical cannabis use completely.

The approval of Epidiolex could mean a shift in the medical marijuana industry, especially if the government removes CBD from the Schedule 1 drug list. It could make the benefits of medical marijuana available to everyone who needs it without jumping through hoops to obtain a medical marijuana card at the state level.

Synthetic alternatives and derivatives aren’t as effective as the real thing, but introducing them could still contribute to the overall legalization of cannabis.

It’s too early to tell what kind of effect this new FDA approved drug will have on the marijuana industry — both recreational and medical — but it might be a move in the right direction. Epidiolex has already proven itself as an effective treatment for epilepsy, or the FDA would not have approved it.  Hopefully, this will be the pebble that starts the avalanche of change for marijuana legislation in general.

We still have the biggest hurdle to overcome — Attorney General Jeff Sessions who has been fighting against state-level marijuana legalization since he took office. Currently, though, his fight is making things easier for legal cannabis-related businesses. Taking the fight to illegal growers means many consumers are turning to illicit marijuana businesses to obtain their medication.

Either way, this FDA approval is a good sign for the people who need CBD or related medication for the treatment of their epilepsy or other medical conditions. It might not be as effective as the real thing, but it is a step in the right direction.