The drug has been approved, on June 25, by the U.S. agency following an advisory committee unanimously recommending acceptance in April 2018. According to TechCrunch the agreement concerning Epidiolex represents a milestone in terms of pharmaceuticals, clustered around the acceptance of medical marijuana.
The drug product Epidiolex is designed to treat the most severe types of childhood epilepsy. The product is taken orally, and it consists of “highly purified” cannabidiol with the levels of the psychoactive constituent tetrahydrocannabinol (THC) minimal.
The specific use of the drug is for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older. Dravet syndrome is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures); whereas, Lennox-Gastaut syndrome is a childhood-onset epilepsy that most often appears between the second and sixth year of life and which is characterized by a triad of signs including frequent seizures of multiple types.
The syndromes have a higher early mortality rate than other types of epilepsy and do not respond to many of the other drugs available.
Epidiolex was developed by GW Pharmaceuticals, based in London, U.K. A quote from Justin Gover, the company’s Chief Executive Officer says: “GW’s vision is to be the global leader in prescription cannabinoid medicines, developing and commercializing pharmaceutical products which address clear unmet needs.”
To date the FDA, as Healthcare Packaging reports, has only approved medications that contain synthetic forms of THC. What is notable about the new approval is that it is the first medication actually derived from the marijuana plant itself.
Speaking about the approval, FDA Commissioner Scott Gottlieb stated, signalling the path to other marijuana derived medications: “Controlled clinical trials testing the safety and efficacy of a drug, along with careful review through the FDA’s drug approval process, is the most appropriate way to bring marijuana-derived treatments to patients.”
A further implication from the FDA decision is that cannabidiol is most likely be reclassified by the U.S. Drug Enforcement Agency, something which is set to occur within 90 days following on from the June 25 FDA decision.
