If Epidiolex receives approval from the US authorities, this cannabidiol-based drug could reform US federal law.
Epidiolex, a drug derived from cannabidiol seems to go where no cannabis drug has gone before: the shelf of pharmacies.
A treatment derived from natural cannabidiol in the process of making history
The flagship drug of GW Pharmaceuticals, the Epidiolex, is currently being reviewed by the US Food and Drug Administration (FDA). It treats two rare types of infantile epilepsy - Dravet syndrome and Lennox-Gastaut syndrome. Epidiolex uses CBD, which is known for its impressive medical benefits. Unlike THC, CBD has no psychotropic effects. This makes it an attractive option for drug developers and the FDA.
To date, the FDA has never approved a drug based on cannabinoids. Only drugs containing synthetic forms of THC have been given the go-ahead.
In a study of patients with Dravet syndrome, Epidiolex demonstrated a reduction of 39% in seizure frequency. Indeed, there is no FDA approved treatment for Dravet syndrome. Epidiolex would become a miracle cure for those who suffer in the United States, one person on 40 000.
Epidiolex continues to build its reputation
Thus, the prestigious New England Journal of Medicine has highlighted the results of one of his essays. It involved patients with Lennox-Gastaut syndrome and Epidiolex. About 14 000 to 18 500 patients suffer from LGS in the United States.
The study focused on 225 patients with LGS. 76 received Epidiolex at high dose, 73 at low dose Epidiolex and 76 at placebo. During a reference period of four weeks, 85 epileptic seizures were recorded resulting in a sudden loss of muscle strength. However, after a treatment period of 14 weeks, the frequency of epileptic seizures decreased by 17,2% in the placebo group, 37,2% in the low dose Epidiolex arm and 41,9% in the Epidiolex arm to strong dose. This is another clear feather in the cap for the Epidiolex.
GW Pharmaceuticals also announced last month that the FDA's advisory committee had recommended Epidiolex by unanimous vote. While the FDA is not required to follow the advice of its advisory board, it generally follows its advice. If Epidiolex were given the go-ahead by the FDA by its decision-making date of Xuumx June XUUMX, it would go down in history.