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GW Pharmaceuticals Announces Second Positive Phase 3 Pivotal Trial for EPIDIOLEX® (cannabidiol) oral solution CV in Patients with Dravet Syndrome

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: “GWP,” “GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive top-line results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of EPIDIOLEX® (cannabidiol or CBD) CV in the treatment of seizures associated with Dravet syndrome, a rare and severe form of childhood-onset epilepsy. In this trial, EPIDIOLEX, when added to the patient’s current treatment, achieved the primary endpoint of reduction in convulsive seizures for both dose levels (10 mg/kg per day and 20 mg/kg per day) with high statistical significance compared to placebo. Both EPIDIOLEX doses also demonstrated statistically significant improvements on all key secondary endpoints.

“The positive outcome in this second trial of EPIDIOLEX in patients with Dravet syndrome further reinforces the effectiveness of this newly available medicine in this particularly difficult to treat, childhood-onset epilepsy,” stated Ian Miller, M.D., Director, Epilepsy and Neurophysiology Program at Nicklaus Children’s Hospital in Miami, FL and principal investigator of the trial. “The totality of data from the controlled clinical trials completed for EPIDIOLEX have shown clinically meaningful seizure reductions and a consistent safety and tolerability profile. I am excited that this recently approved and important new treatment option is now available for my patients.”

“The positive results from this trial follow the recent FDA approval, DEA rescheduling and U.S. launch of EPIDIOLEX for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut Syndrome in patients two years and older. These data show an effective dose range in Dravet syndrome that is consistent with our FDA approved label, and which allows for dosing flexibility to address individual patient needs,” stated Justin Gover, GW’s CEO. “We are proud to have recently launched EPIDIOLEX, the first FDA-approved plant-derived cannabinoid medicine and are excited about its potential to help the lives of patients and their families.”

“This new important EPIDIOLEX data is good news for the Dravet syndrome community and offers further scientific evidence for this newly available therapy,” said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation. “As the first FDA-approved medicine for patients with Dravet syndrome, EPIDIOLEX offers hope to individuals who previously had few options available to effectively control their seizures.”

“The positive results from this latest EPIDIOLEX clinical trial are very encouraging for those living with intractable seizures caused by LGS and Dravet syndrome, two extremely difficult treatment-resistant forms of epilepsy,” said Philip M. Gattone, president and CEO of the Epilepsy Foundation. “This trial increases the body of scientific evidence to support the only FDA-approved cannabidiol therapy and provides hope to the most vulnerable individuals in our epilepsy community who are trying to gain better seizure control. We thank GW and all our partners who invest in a better tomorrow for people with epilepsy.”

Trial Overview and Results

Patients aged 2-18 years with a confirmed diagnosis of drug-resistant Dravet syndrome currently uncontrolled on one or more concomitant anti-epileptic drugs (AEDs) were eligible to participate in this Phase 3, randomized, double-blind placebo-controlled trial. The trial randomized 199 patients into three arms, where EPIDIOLEX 20 mg/kg/day (n=67), EPIDIOLEX 10 mg/kg/day (n=67) or placebo (n=65) was added to current AED treatment. On average, patients were taking three AEDs, having previously tried and discontinued on average, four other AEDs. The average age of trial participants was nine years (range 2-18). The median baseline convulsive seizure frequency per month was 12 and the median baseline total seizure frequency per month was 35.

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