FDA approved cannabis-derived products

This article is about FDA approved cannabis-derived products.

The FDA has approved one cannabis-derived product and three cannabis-related products. There are other cannabis-related medications outside the US.

Medications that the FDA approved in the US might not be approved in the EU. Even if one EU country approved certain medications, other EU countries or the US may not have approved them.

However, the FDA has not approved cannabis, as a plant, for the treatment of any condition or disease.

We are discussing the following topics:

FDA approved CBD medications
FDA approved THC medications
Cannabis-derived medications approved in the European Union but not in the United States
Cannabis-derived products that are not FDA approved
The drug authorization process in the US – FDA approval
Phases of clinical research
Access to cannabis derived products that are not FDA-approved

FDA approved CBD medications

The FDA has approved one cannabis-derived product:

Purified CBD under the name Epidiolex (the maker is Greenwich Biosciences).

Epidiolex is a prescription medicine to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.

It is now in Schedule V of the Controlled Substances Act (CSA), which is the least restrictive schedule of the CSA.

FDA approved THC medications

The FDA has approved three cannabis-related products:

Dronabinol is a synthetic THC, which the FDA approved under the names
- Marinol (the maker is AbbVie Inc.) and
- Syndros (the maker is Insys Therapeutics Inc.)
Nabilone is another synthetic cannabinoid that has a chemical structure similar to THC, which the FDA approved under the name Cesamet (offered by Bausch Health)

Marinol and Syndros are prescription medicines to treat anorexia in people with AIDS who have lost weight and to treat nausea and vomiting caused by chemotherapy in cancer patients.

Cesamet is a prescription medicine to treat nausea and vomiting associated with chemotherapy in cancer patients.

Marinol, Syndros, and Cesamet are CSA Schedule II drugs, meaning they have high potential for abuse, with use potentially leading to severe psychological or physical dependence.

Based on scientific information makers of the drugs have provided to the agency, the FDA concluded that the above drugs are effective medicines for their intended uses, and they are also safe to use.

Cannabis-derived medications approved in the European Union but not in the United States

Cannabis-related medications that are approved in Europe, but not in the US are:

Sativex (a medication containing THC:CBD in a 1:1 ratio), and
Canemes (Nabilone).

Currently there are no cannabis-related medications centrally (EMA) approved in all EU countries. Only certain EU countries authorized the above medications.

Cannabis-derived products that are not FDA approved

Apart from Epidiolex, Marinol, Syndros, and Cesamet, there are no other FDA- or EU regulatory-approved drugs that contain CBD.

There are CBD products available on the market for medical, therapeutic, or dietary uses without regulatory approval and without regulatory authority review. However, these products have have no proof of being safe or effective because nobody evaluated them for

whether they actually have the ingredients that they claim to have
the purity of the ingredients that they claim to have
whether these products work
what the appropriate dosage is if they work
how they might interact with other medications and
whether they have safety concerns or side effects

The drug authorization process in the US – FDA approval

The FDA supports the development of new drugs, but these potential medications must undergo a rigorous drug approval process. First, the maker of the drug conducts a large number of scientific investigations and experiments to support their claims.

For example, in the US, companies need to submit an Investigational New Drug Application to the FDA’s Center for Drug Evaluation and Research. However, conducting clinical research using cannabis-related products that are CSA scheduled often involves other federal agencies besides the FDA, such as:

the Drug Enforcement Administration (DEA) and
the National Institute on Drug Abuse (NIDA).

Before entering the market, drugs must receive approval from the FDA through a process called New Drug Application (NDS). Alternatively, they can undergo an over-the-counter (OTC) drug review. According to the FDA, however, CBD is not an OTC drug either.

Phases of clinical research

There are six phases of clinical research that are necessary in order to collect evidence that a new drug works:

Preclinical: animal and laboratory (non-human) experiments to look at the effect of the drug
Phase 0: experiments on a very small number of people (about ten or so) to test the effect
Phase I: experiments on a small number of people (20-80) to assess safety and doses
Phase II: experiments on a group of people (100-300) to assess efficacy and side effects
Phase III: experiments on a group of people (1,000-3,000) to assess efficacy, effectiveness, and safety

The drug maker will provide scientific publications of these experiments in order to receive regulatory approval. The regulatory agency will then decide based on this submitted information whether to approve the drug.

Phase IV: even after approval, drug makers must conduct so-called post-marketing surveillance studies with real world patient data (tens of thousands and millions of users) to monitor the drug’s long-term effect and safety.

Access to cannabis derived products that are not FDA-approved

Despite the strict FDA regulation, there are other ways to legally try cannabis-based medications in the US. Patients can have access to cannabis-derived products that are not yet FDA approved medications through:

Expanded access:
- For patients with an immediately life-threatening condition or serious disease or condition
- to gain access to an investigational Phase II or Phase III medical product
- outside of clinical trials
Right to Try:
- For patients with life-threatening diseases or conditions
- to gain access to an investigational Phase I medical product
- outside of clinical trials