FDA endorsed Epidiolex – first marijuana medication on Monday June 25. The new drug – Epidiolex is an oral solution made up of cannabidiol (CBD), which is a chemical component derived from marijuana plants that doesn’t lead to euphoric high or intoxication.
The drug has been approved by the US Food and Drug Administration to be used for patients ageing two years or older than that suffering serious types of epilepsies, called as Dravet syndrome and Lennox-Gastaut syndrome, which are able to develop in adolescence.
GW Pharmaceuticals plc, a British biopharmaceutical company known for multiple sclerosis treatment product nabiximols, expects another considerable choice in next few weeks, i.e. to get US Drug Enforcement Administration for reclassifying CBD.
Scott Gottlieb, FDA Commissioner said in a statement, “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.”
CBD along with other marijuana components is currently classified as Schedule I drug by the DEA. The Schedule I drugs include LSD, marijuana as well as heroin. Such drugs are characterized as the components with ‘no currently accepted medical use’ and high abuse potential.
CEO of GW Pharmaceuticals plc, Justin Gover stated, “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”