Epidiolex, a cannabis-based medicine recently approved by the FDA for the treatment of Dravet and Lennox-Gastaut syndromes, is the first drug containing Cannabidiol or CBD to be officially marketed for epilepsy therapy. Initially approved in June by the Food and Drug Administration (FDA), the US drug agency, the first Cannabidiol-based medicine against two epilepsy form is now available in the United States since November 1st.
The drug, which is an oral solution prepared by the British company GW Pharmaceuticals, is designed to treat Dravet and Lennox-Gastaut syndromes. “Because these patients have always reacted poorly to available medicines, there is an urgent need for new treatments to reduce the frequency and impact of seizures,” said Justin Gover, CEO of the pharmaceutical company, in a statement.
That is the first time that the FDA has approved a product based on Cannabis for medical use. That because Cannabidiol, even though it’s extracted from Cannabis, it is not responsible for the “high” state in users as it is different from THC, the psychoactive substance in Cannabis.
In a 2017 British clinical the trial on 225 patients with Lennox-Gastaut syndrome, Cannabidiol or CBD has yielded positive results in keeping the condition under control.
Epidiolex, a Cannabidiol-based drug against epilepsy, approved by FDA
“Compared to other drugs used to treat epilepsy, I think Epidiolex, which contains 99% pure Cannabidiol (CBD), has a better side effect profile than many of the available drugs,” said Dr. Orrin Devinsky, the study’s leading researcher of the third clinical trial that demonstrated the efficacy of Epidiolex in treating Dravet and Lennox-Gastaut syndromes.
Nevertheless, the FDA noted in its Epidiolex approval statement that side effects may occur, such as drowsiness, lethargy, lack of appetite, diarrhea or infections, among others.
“This approval reminds us that the implementation of rational development programs that properly evaluate the active ingredients contained in Marijuana can lead to important medical therapies. And the FDA is committed to this type of scientific research and drug development,” concluded the FDA Commissioner, Scott Gottlieb, in a statement of approval.
Vadim is a passionate writer on various topics but especially on stuff related to health, technology, and science. Therefore, for Great Lakes Ledger, Vadim will cover health and Sci&Tech news.