UK-based GW Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its marijuana-based Epidiolex oral solution to treat seizures caused due to Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe types of epilepsy that begin in childhood.
Epidiolex is the first cannabis-derived drug to be approved by the FDA. It is also the first in a new class of anti-epileptic medications, and to secure the US regulatory authorisation to treat Dravet syndrome.
Indicated for patients aged two years and above, Epidiolex contains cannabidiol (CBD) as its active ingredient. CBD is a chemical component derived from the cannabis plant, but does not lead to intoxication or euphoria, unlike its co-component tetrahydrocannabinol (THC).
FDA commissioner Scott Gottlieb said: “This approval serves as a reminder that advancing sound development programmes that properly evaluate active ingredients contained in marijuana can lead to important medical therapies.
“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.”
Gottlieb added that the regulatory agency will also monitor the illegal marketing of products that contain CBD and come with serious, unproven medical claims.
Epidiolex was evaluated in three randomised, double-blind, placebo-controlled clinical trials with a total of 516 participants suffering from Lennox-Gastaut or Dravet syndrome.
Data showed that use of Epidiolex along with other anti-epileptic medications can effectively minimise the frequency of seizures when compared to placebo. The most common adverse reactions during the studies were sleepiness, sedation, lethargy and diarrhea, among others.
Expected to be available to appropriate patients over the coming months, Epidiolex will be marketed by GW Pharma’s US subsidiary Greenwich Biosciences.