Pharmaceutical grade cannabidiol (CBD) (Epidiolex; Greenwich Biosciences, Carlsbad, CA), approved by the FDA for treatment of patients age 2 and up with Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome (DS) is now available by prescription.
This pharmaceutical, regulated formulation of CBD is a first-in-class antiepileptic drug derived from the cannabis plant; it contains less than 0.1% of delta-tetrohydrocannabinol and does not induce the psychoactive effects, or “high,” of marijuana. It is manufactured and purified in a controlled manner that ensures each dose delivers the same amount of CBD every time it is given to a patient. This specific formulation is the only CBD to be rescheduled by the DEA as an uncontrolled Schedule 5 substance by the Drug Enforcement Agency (DEA).
In phase 3 trials, this formulation of CBD reduced the frequency of drop seizures for patients with LGS by as much as 41.9% compared to a 17.2% decrease seen with placebo. Patients with DS experienced decreases in seizure frequency of 39% compared to a 13% decrease seen with placebo. This is the first drug approved for the treatment of patients with DS.
A comprehensive patient-support plan titled Epidiolex-Engage has been inititated to assist patients and their caregivers access the medication by providing education and resources to help lower or eliminate out-of-pockets costs for eligible patients.
As noted previously by Justin Gover, Chief Executive Officer of GW Pharmaceuticals when CBD was approved, this 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.” Today he said, “We are committed to ensuring that these patients can access this novel cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and is eligible to be covered by insurance for appropriate patients.”
Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation stated, “Our community has long desired a medication specifically approved for the treatment of seizures associated with Dravet syndrome, and the availability of epidiolex is an important milestone for patients and caregivers whose lives are significantly impacted by this catastrophic, lifelong form of epilepsy.”
Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation said, “Despite the use of multiple epilepsy treatments, the majority of LGS patients continue to have life-long, debilitating seizures and our community welcomes the availability of a new, first-in-class treatment option.”