NICE Issues Positive Recommendation for Cannabidiol Oral Solution to Treat Epilepsy

November 14, 2019
Pharmaceutical Technology Editors

NICE has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.

The United Kingdom’s National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for GW Pharmaceuticals’ Epidyolex (cannabidiol) oral solution for the treatment of seizures in patients with a rare form of childhood-onset epilepsy.

GW Pharmaceuticals released the news in a Nov. 10, 2019 press release, while also welcoming the decision by NICE to recommend reimbursement for another of its medicines, Sativex (nabiximols), used to treat spasticity resulting from multiple sclerosis (MS), on the National Health Service (NHS). The decisions taken by NICE on the aforementioned treatments represent the first time that plant-derived cannabis-based medicines have been recommended for use on the NHS.

“This is a momentous occasion for UK patients and families who have waited for so many years for rigorously tested, evidenced and regulatory approved cannabis-based medicines to be reimbursed by the NHS,” said Chris Tovey, GW’s chief operating officer, in the press release. “This is proof that cannabis-based medicines can successfully go through extensive randomized placebo-controlled trials and a rigorous NICE evaluation process to reach patients. I am hugely proud of the entire GW team for achieving this milestone in the country where the company was founded and where both of these medicines were developed and are manufactured.”

“This is a significant moment for adults and children with the most difficult to treat epilepsies,” added Dr. Rhys Thomas, consultant neurologist at the Royal Victoria Hospital in Newcastle. “NICE’s recommendation of cannabidiol oral solution follows a period of great anticipation and enthusiasm for patients and their clinicians. The European Medicines Agency (EMA) license and availability through the NHS is welcome as we badly need additional effective treatments for Dravet and Lennox Gastaut syndromes (LGS).”

EMA approval for Epidyolex as an adjunctive therapy in conjunction with clobazam for seizures associated with LGS or Dravet syndrome in patients aged two years and older was granted in September 2019.

Source: GW Pharmaceuticals