How does the approval process for drugs with cannabis components proceed?
Currently, interest in cannabis and its application in medicine is growing. Doctors are discovering many new potentially positive effects of cannabis. The foreign organization FDA (Food and Drug Administration) deals with the approval of medications containing cannabis components. However, they are very cautious in their approval and have not yet approved any treatment purely using cannabis.
What cannabis compounds are used in medications?
We are talking about medicinal preparations with cannabis components. But what does this mean? Practically, these are chemical substances from which all medications are typically made, with cannabis compounds added. These are divided based on whether they are:
- Derived from cannabis: These include compounds naturally found in the cannabis plant. These are mainly CBD and THC. These compounds are extracted directly from the plant.
- Related to cannabis: These are artificially created compounds synthesized in a laboratory. Examples include dronabinol and nabilone. Some of these naturally occur in cannabis, but there may not be enough, so their production occurs under expert supervision in a chemical environment.
Medications with Cannabis Components
FDA Approved Three Cannabis-Based Medications
To date, 3 medications containing cannabis have been officially approved. Specifically, these are the well-known Epidiolex, Marinol, Syndros, and Cesamet. Their use is tied to a medical prescription from the relevant doctor. You can usually find them in selected pharmacies. Let's discuss them in more detail:
Epidiolex: It is the first and longest-approved medication worldwide. It contains a purified form of the medicinal substance cannabidiol (CBD). It is prescribed to people with epilepsy and Lennox-Gastaut syndrome. It is intended for adults and children from 2 years and older.
Marinol and Syndros: Their use is currently approved only in the United States. They are most commonly used for severe forms of nausea that arise as a consequence of cancer or other serious illnesses. They contain dronabinol, an effective substance that binds to THC.
Cesamet: The active ingredient in this medication is nabilone, which has a chemical structure similar to THC. It is synthetically produced and is also prescribed for severe nausea.
FDA Approves Relevant Cannabis-Based Medications
Medication Approval Process for Cannabis
The FDA is well aware of its responsibility in the medical environment. Therefore, doctors, nurses, and patients can always be sure that medications approved by this organization are effective, high-quality, and completely safe. The FDA aims to approve cannabis medications for therapy for patients who have not yet received assistance. However, this is not a simple process and consists of several interconnected steps. If a specialist is interested in approving a cannabis medication, the procedure is as follows:
- Meeting with FDA experts
- Contacting a registered cannabis source
- Discussing research
- Obtaining authorization and all data
- Sending a copy and protocol
- FDA review, which will either grant or deny the request
- If the request is granted, a clinical study/research begins
The FDA ensures that cannabis-based medications introduced to the market meet all criteria. The approval of medications is preceded by long-term research that demonstrates effects and potential indications. In Slovakia and the Czech Republic, these medications are still not considered standard. Only recently was the CBD component legalized in Slovakia, and in the Czech Republic, there was a change regarding medical marijuana last year.