A marijuana-based drug named Epidiolex has been approved by the US FDA (Food and Drug Administration). It’s the first cannabis-based drug to get greenlight in the United States to treat patients suffering from severe epilepsy.
Epidiolex contains CBD which is short for cannabidiol, a chemical derived from cannabis. It will be used for the treatment of seizures associated with two rare and severe forms of epilepsy- Lennox-Gastaut syndrome and Dravet syndrome. CBD does not cause intoxication or euphoria, it is the THC (tetrahydrocannabinol) that gets a person high when consumed.
After conducting its own trials, FDA has finally approved the medicine which will be used to treat patients above the age of 2 years. Epidiolex, developed by GW Research Ltd., is also the first drug approved by FDA to treat Dravet Syndrome. Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures).
On the other hand, Lennox-Gastaut syndrome begins in childhood (usually between 3 to 5 years of age) and is characterized by multiple types of seizures. Almost all children with Lennox-Gastaut syndrome develop learning problems and intellectual disability.
“This approval serves as a reminder that advancing sound development programs that properly evaluate active ingredients contained in marijuana can lead to important medical therapies. And, the FDA is committed to this kind of careful scientific research and drug development,” said FDA Commissioner Scott Gottlieb, M.D.
“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” said Justin Gover, GW’s Chief Executive Officer.
CBD, under the Controlled Substances Act, is still considered a Schedule I substance in the United States which is defined by DEA (Drug Enforcement Administration) as “drugs with no currently accepted medical use and a high potential for abuse.” Patients still won’t have access to the medicine even after getting approved by the FDA until CBD is rescheduled by the DEA, which is expected to happen within 90 days.
“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high-quality products. But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims,” added Scott Gottlieb.
Greenwich Biosciences is also planning to make the medicine available in Europe as the drug is currently under review by the EMA (European Medicines Agency). EMA’s decision on whether to recommend approval is expected in the first quarter of 2019, claimed the company.
