GW Pharmaceuticals’ Epidiolex has become the first cannabinoid prescription medicine to be approved in the US, winning clearance to treat two rare forms of epilepsy.
In a historic move, the US Food and Drug Administration has given the green light for the drug’s use to treat seizures associated with Lennox-Gastaut Syndrome or Dravet Syndrome, two rare, severe and notoriously difficult-to-treat childhood-onset epilepsies.
“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,” noted the UK firm’s chief executive Justin Gover.
“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.”
Epidiolex contains cannabidiol (CBD), a chemical component of the cannabis sativa plant, more commonly known as marijuana. CBD does not cause intoxication or euphoria that comes from tetrahydrocannabinol (THC), the primary psychoactive component of the drug.
“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.
Read more: http://www.pharmatimes.com/news/fda_approves_gws_cannabinoid_drug_epidiolex_1241983