The U.S. Food and Drug Administration has approved a marijuana-based drug for the first time, pacing the way for more research into an ingredient that is still illegal in federal law despite increasing legalization for medical and recreational purposes.
The drug, named Epidiolex, received unanimous recommendation from an FDA advisory committee in April. The approval comes as good news for the supporters of the drug, which is being used to treat children suffering from severe forms of epilepsy and seizures.
Here’s What You Need To Know About Epidiolex
The FDA approved the prescription of Epidiolex for patients 2 years old and older for the treatment of two forms of epileptic syndromes. The first is Dravet syndrome, which is a rare genetic dysfunction that starts within a child’s first year, and the second is Lennox-Gastaut syndrome, which is a form of epilepsy that causes multiple types of seizures usually starting from 3 to 5 years old.
The strawberry-flavored syrup is a purified form of cannabidiol or CBD, one of the 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 the instances of seizures in people, but that was the result of studies carried out by GW Pharmaceuticals. The British drugmaker studied the effects of Epidiolex in over 500 patients suffering from hard-to-treat seizures, with positive results.
According to the FDA, Epidiolex reduced cases of seizures when taken in combination with older drugs used for epilepsy treatment.
The effectiveness of Epidiolex has forced parents who have children suffering from epilepsy to move to states where marijuana has been legalized. With the FDA approval, that will no longer be a requirement, though there are concerns that it will lead to the restriction of other cannabis products.
The Future Of Marijuana-Based Drugs
In a statement, FDA Commissioner Dr. Scott Gottlieb said that 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 drug’s uniform strength and consistent delivery,” Gottlieb added.
Gottlieb, however, noted that the approval for Epidiolex does not mean that marijuana and all of its components have also received approval. Only one specific CBD medication was approved, and only for a specific use.
The FDA, meanwhile, has opened the path for other drug developers who want to gain approval for marijuana-based medicine. This should mean that more drugs derived from marijuana should make their way through the FDA approval process in the near future.