Marijuana-Derived Medications: FDA-Approved Cannabinoids as of August 2018

Let’s start with the fact that dronabinol (Marinol, Syndros), nabilone (Cesamet) and cannabidiol (Epidiolex) are medications approved by the FDA. Currently, there is no-FDA approved medical indication for prescribing marijuana. Why is one approved and not the other? Do they work? What are their differences?

Here’s what you should know.

What is marijuana FDA-approved for?

Nothing, yet. Both the European Medicines Agency (EMA) and the United States FDA do not approve of the use of herbal cannabis or its extracts. The use of medical marijuana—the whole, unprocessed plant or its basic extracts—for refractory cancer pain is very controversial as it hasn’t been well-studied. Marijuana use is still illegal in the United States at the federal level. It’s considered a schedule I controlled substance, which makes it difficult to study.  

What about components of marijuana?

Cannabis sativa, the marijuana plant, contains over 400 compounds, including more than 60 different types of cannabinoids. Two cannabinoids in particular have been studied for medicinal uses: delta-9-tetrahydrocannabinol (often referred to just as THC) and cannabidiol (CBD).

There are currently four FDA-approved cannabinoid medicines available in the United States:

Marinol and Syndros (dronabinol)

Marinol and Syndros (dronabinol) is a pill or solution containing synthetic THC. Of the current four cannabinoid medicines, dronabinol is the best studied. The main indications for the use of dronabinol are 1) stimulating appetite in patients with AIDS or cancer and counteract weight loss, and 2) mitigate nausea and vomiting associated with chemotherapy. They begin working within 30 minutes to one hour, with peak effect at two to four hours.

Dronabinol has been studied for postoperative and neuropathic pain and was not found to be any better than placebo. For chronic non-cancer pain, it has been found to be only slightly better than placebo.

Cesamet (nabilone)

Nabilone (Cesamet) is a capsule that contains a synthetic cannabinoid similar to THC.  Like dronabinol, nabilone is used for nausea and vomiting caused by chemotherapy.

Epidiolex (cannabidiol)

Lastly, cannabidiol (Epidiolex) liquid solution was just approved by the FDA in June 2018 for seizure disorder associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana.

What’s next?

Clinical research on marijuana-derived drugs is ongoing. It involves several federal agencies, including the DEA (Drug Enforcement Administration), NIDA (National Institute on Drug Abuse) and FDA (Federal Food and Drug Administration). They regulate samples used for research and review clinical research on therapeutic benefits, side effects, and long-term health impacts of new drug contenders—like nabiximols (Sativex), an oral spray with two cannabinoids (THC and CBD) that is not yet approved by the FDA, but is endorsed by the American Academy of Neurology for treatment of spasticity (muscle rigidity) and nerve pain in patients with multiple sclerosis.

Dr O.

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