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Additional Late-Stage Study Confirms Efficacy, Safety Of GW Pharma's Epidiolex

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Additional Late-Stage Study Confirms Efficacy, Safety Of GW Pharma's Epidiolex

GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) announced incremental positive news on its lead cannabinoid product candidate Epidiolex, sending the stock higher.

What Happened

GW Pharma announcedpositive results for a second, late-stage study that evaluated its Epidiolex oral solution for treatment seizures associated with Dravet syndrome - a rare and severe form of childhood-onset epilepsy.

The Phase 3 trial showed that Epidiolex, when added to the current treatment regime of the patients, achieved the primary endpoint of reduction in convulsive seizures for two doses, namely 10 mg/kg per day and 20 mg/kg per day, achieving statistically significant improvement relative to the placebo.

The pipeline asset showed statistically significant improvements on all key secondary endpoints, the company said.

Why It's Important

Epidiolex was approved by the FDA in June for treating epilepsy associated with both Dravet and Lennox-Gataut syndromes.

Later in September, the U.S. Drug Enforcement Administration agreed to reclassify the drug as a Schedule V drug, which makes it legal in the U.S.

"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," said GW Pharma CEO Justin Gover. "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."

What's Next

The company plans to present the results at future a medical conference, and subsequently publish these in a medical journal.

Shares were trading higher by 6 percent to $131.80 at time of publication Monday morning.

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