Cannabidiol Drug Reduces Seizure Rate in New Study

In a Phase III trial, the investigational medicine Epidiolex (cannabidiol, GW Pharmaceuticals plc) performed significantly better than placebo in reducing convulsive seizures in children with Dravet syndrome, a rare and severe form of epilepsy. Cannabidiol is a liquid formulation of pure plant-derived cannabidiol.

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The study involved 120 children whose average age was 10. Participants had an average of 13 convulsive seizures during 4-week observation period. Afterward, investigators randomly assigned the children to 14 weeks of treatment with cannabidiol (20 mg/kg/day) or placebo.

Children taking cannabidiol had, on average, a 39% reduction in monthly convulsive seizures, according to GW Pharmaceuticals, compared with a 13% reduction among children taking placebo. The difference between cannabidiol and placebo was apparent during the first month of treatment and continued the entire 14 weeks.

The most common adverse events associated with cannabidiol, which occurred in more than 10% of children receiving the biopharmaceutical, were somnolence, diarrhea, decreased appetite, fatigue, pyrexia, vomiting, lethargy, upper respiratory tract infection, and convulsion.

The FDA has granted GW Pharmaceuticals both an orphan drug and a fast-track designation for Epidiolex. Dravet syndrome has no FDA-approved treatment.—Jolynn Tumolo

Reference

GW Pharmaceuticals announces positive Phase 3 pivotal study results for Epidiolex (cannabidiol) [press release]. GW Pharmaceuticals: London; March 14, 2016.