Greenwich Biosciences, a GW Pharmaceuticals Company, Presents New Data for EPIDIOLEX (cannabidiol) in Patients with Tuberous Sclerosis Complex (TSC) at the American Epilepsy Society Annual Meeting

Study results showed EPIDIOLEX significantly reduced difficult-to-treat seizures associated with TSC and improved overall patient condition as reported by caregivers

CARLSBAD, Calif., Dec. 07, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences, today presented new data from a Phase 3 clinical trial of EPIDIOLEX (cannabidiol or CBD) oral solution, CV in tuberous sclerosis complex (TSC) at the American Epilepsy Society (AES) Annual Meeting. The study found that patients treated with EPIDIOLEX 25 mg/kg/day or 50 mg/kg/day experienced a significantly greater reduction in TSC-associated seizures (49% for 25 mg/kg/day and 48% for 50 mg/kg/day) compared to placebo (27%; p=0.0009 and p=0.0018, respectively).

“Epilepsy is the most common neurological feature of TSC,^1,2,3 a rare and severe childhood-onset disease, and as many as two-thirds of patients experience treatment-resistant seizures,”⁴ said Elizabeth Thiele, M.D, Ph.D., director of pediatric epilepsy and director of The Carol and James Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, professor of neurology at Harvard Medical School, Boston and lead investigator of the trial. “There is a significant need for new treatments to address TSC-related seizures and these positive results suggest patients may benefit from this pharmaceutical formulation of highly-purified CBD.”

New secondary endpoint data, presented for the first time at AES, showed that more patients on EPIDIOLEX experienced a 50% or greater reduction in seizures (36% for 25 mg/kg/day and 40% for 50 mg/kg/day) compared to placebo (22%; p=0.0692 and p=0.0245, respectively). Additionally, 48% of patients taking either dose of EPIDIOLEX in the study experienced a greater reduction in total seizure frequency compared to placebo (27%; p=0.0013 and p=0.0018, respectively). Caregivers and patients also reported overall improvement with EPIDIOLEX in 69% of patients on 25 mg/kg/day and 62% of patients on 50 mg/kg/day compared to 39% on placebo (p=0.0074 and p=0.0580, respectively). Additional analysis showed that patients taking EPIDIOLEX in the study experienced a greater reduction in composite focal seizures (52% for 25 mg/kg/day and 50% for 50 mg/kg/day) compared to placebo (32%; p=0.0076 and p=0.0116, respectively).