United States: FDA gives green light to Epidiolex

Epidiolex, a drug based on cannabidiol (CBD) for the treatment of epilepsy, particularly in children, received this week the support of the Food and Drug Administration, opening the door to future final approval.

CBD has been used for many years to treat epileptic seizures, as well as other pathologies, in both children and adults. In the United States, CBD is sold on the medical and recreational markets in States where cannabis is legal, and as a hemp derivative in other states.

In their preliminary advisory report, FDA officials concluded that in three studies involving over 500 patients, Epidiolex reduced the number of seizures in patients with Lennox Gastaut Syndrome (LGS) and Dravet Syndrome (DS), two rare types of childhood epilepsy, by around 40%.

«Clinically and statistically significant reductions in seizure frequency were demonstrated in three adequate and well-controlled trials for LGS and DS,» detailed the FDA report. «The results of these three studies provide substantial evidence of the efficacy of CBD for the treatment of seizures associated with LGS and DS.»

Unlike other pharmaceutical companies that have tried to synthesize THC and CBD for the US medical market, Epidiolex is made from natural CBD, which has fewer side effects than synthetic cannabinoids.

All that remains now is to go through a panel of experts, who will make their decision on June 27. If this CBD drug receives final FDA approval, it could be marketed as early as July this year.

The action of GW Pharmaceuticals, the company that manufactures and distributes Epidiolex, took 11% in less than 24 hours after the FDA announcement.