JAMA Neurology Publishes Results from Positive Phase 3 Trial of EPIDIOLEX (cannabidiol) oral solution in Children with Seizures Associated with Dravet Syndrome

EPIDIOLEX significantly reduced convulsive seizure frequency in children taking multiple anti-epileptic drugs with poor seizure control

CARLSBAD, Calif., March 02, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, announced today that JAMA Neurology has published results from the second positive Phase 3 trial (GWPCARE2) of EPIDIOLEX (cannabidiol) oral solution CV in children with seizures associated with Dravet syndrome. The article has been published online and will be included in the May 2020 print issue of the journal. EPIDIOLEX, a pharmaceutical formulation of highly purified cannabidiol (CBD), is the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older.

In the study, two doses of EPIDIOLEX, 10 and 20 mg/kg/day, significantly reduced convulsive seizure frequency compared to placebo in children two to 18 years of age with highly treatment-resistant Dravet syndrome, meeting the study’s primary endpoint. The primary endpoint outcomes for the 10 and 20 mg/kg/day arms were similar, with seizure reductions of 49% and 46% from baseline, respectively, vs 27% for placebo (10 mg/kg/day, p=0.0095 and 20 mg/kg/day, p=0.0299).

“Dravet syndrome is one of the most difficult-to-treat forms of epilepsy and patients are highly individualized in their symptoms and dosing needs,” said Ian Miller, M.D., Chief of Neurology at Nicklaus Children's Hospital in Miami, FL and lead author. “The data published by JAMA Neurology show that EPIDIOLEX 10 and 20 mg/kg/day were both efficacious and significantly reduced convulsive seizures. Drug-resistant seizures are common with Dravet syndrome and it is valuable to have a range of approved doses that offer physicians the flexibility to adjust treatment to a patient’s specific needs.”

Results from key secondary endpoints also showed:

• Significant reductions in total seizure frequency from baseline: 56% for 10 mg/kg/day and 47% for 20 mg/kg/day vs 30% for placebo (p=0.0003 and p=0.0255, respectively).
   
• Significantly more patients taking EPIDIOLEX (44% on 10 mg/kg/day and 49% on 20 mg/kg/day) achieved a 50 percent or greater reduction in convulsive seizures from baseline during the treatment period compared to placebo (26%; p=0.0332 and p=0.0069, respectively).