FDA approves the first marijuana drug in the United States: Here's What You Need to Know About Epidiolex



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The Food and Drug Administration has approved Epidiolex, the first marijuana drug in the United States. Epidiolex is intended for the treatment of epilepsy and seizures in children as early as 1 year of age.
( Rex Medlen | pixabay )

The US Food and Drug Administration has approved a marijuana drug for the first time, paving the way for further research on an ingredient still illegal in federal law despite increasing legalization for medical and recreational purposes .

The drug, named Epidiolex, received the unanimous recommendation of an FDA advisory committee in April. The approval is good news for proponents of the drug, which is used to treat children with severe forms of epilepsy and seizures.

Here is what you need to know about Epidiolex

The FDA has approved the prescription of Epidiolex for patients 2 years of age and older for the treatment of two forms of epileptic syndromes. The first is Dravet syndrome, which is a rare genetic dysfunction that begins during the first year of the child, and the second is Lennox-Gastaut syndrome, a form of epilepsy that causes several types of seizures usually begin between 3 and 5 years old.

Strawberry flavored syrup is a purified form of Cannabidiol or CBD, one of more than 80 chemicals found in cannabis plants. However, unlike tetrahydrocannabinol or THC, it does not give people who take it a high.

It is unclear how CBD reduces cases of seizures in people, but this is the result of studies conducted by GW Pharmaceuticals. The British drug maker has studied the effects of Epidiolex in more than 500 patients with difficult-to-treat epileptic seizures, with positive results.

According to the FDA, Epidiolex reduces cases of seizures when it is taken in combination with older drugs used for the treatment of epilepsy.

The effectiveness of Epidiolex has forced parents who have children with epilepsy to relocate to states where marijuana has been legalized. With the approval of the FDA, this will no longer be a requirement, although it is feared that this will lead to the restriction of other cannabis products.

The future of marijuana-based drugs

In a statement, FDA Commissioner Dr. Scott Gottlieb said the approval of Epidiolex is "an important medical advance".

"Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the uniform strength of the drug and the consistent delivery," added Gottlieb.

Gottlieb, however, noted that the approval of Epidiolex does not mean that marijuana and all its components have also received approval. Only one specific CBD drug has been approved, and only for a specific use.

The FDA, meanwhile, has paved the way for other drug developers who want to get approval for marijuana medicine. This should mean that more marijuana-derived drugs should make their way through the FDA approval process in the near future.

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