Epidiolex (cannabidiol oral solution) has been made available by GW Pharmaceuticals for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients ≥2 years old.
The Food and Drug Administration (FDA) approved the treatment in June 2018, making it the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol, as well as the first treatment indicated for patients with Dravet syndrome. The approval of Epidiolex was based on data from 3 randomized, double-blind, placebo-controlled trials involving patients with either LGS or Dravet syndrome. In September 2018, Epidiolex was rescheduled from a Schedule I substance to a Schedule V, the lowest restriction classification.
Epidiolex is supplied as a 100mg/mL strawberry-flavored oral solution. The product is packaged with a calibrated measuring device and is recommended to measure and deliver the prescribed dose. Any unused portion of the medication should be discarded after 12 weeks of first opening the bottle.
Prior to starting treatment, patient serum transaminases (ALT and AST) and total bilirubin levels should be obtained because of the risk of hepatocellular injury. Food may affect levels of Epidiolex, therefore patients should be advised to take the drug consistently either in the fasted or fed state.
GW Pharmaceuticals has also launched the Epidiolex Engage support program to help patients and clinicians navigate the steps to obtaining Epidiolex; the program also provides education and resources to patients and caregivers.
“We are delighted to announce that Epidiolex is now available by physician prescription as a new treatment option for patients with LGS and Dravet syndrome, two of the most difficult-to-treat forms of childhood-onset epilepsy,” said Justin Gover, Chief Executive Officer of GW Pharmaceuticals. “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.”
For more information visit epidiolexhcp.com.