GW conducts study showing the potential of cannabidiol in reducing seizures

GW Pharmaceuticals and its U.S. subsidiary Greenwich Biosciences, have conducted a study which showed the potential of cannabidiol in reducing seizures. The study was published in The Lancet, the company announced on Wednesday.

The Lancet has published results from a Phase 3 study of Epidiolex (cannabidiol) in patients with Lennox-Gastaut syndrome (LGS). Epidiolex, GW’s lead product candidate and the potential first in a new category of anti-epileptic drugs (AEDs), is a pharmaceutical formulation of purified cannabidiol (CBD), a cannabinoid lacking euphoric side effects, which is being studied for the treatment of a number of rare, severe pediatric-onset epilepsy disorders.

GW noted that a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for Epidiolex for the LGS and Dravet syndrome, another rare childhood-onset epilepsy, was accepted in December with an assigned PDUFA goal date of June 27, 2018. If approved, it should be available in the U.S. by prescription in the second half of 2018, GW said. A Marketing Authorisation Application (MAA) was submitted to the European Medicines Agency (EMA) in December 2017, and GW expects its decision in early 2019.

Elizabeth Thiele, director of pediatric epilepsy at Massachusetts General Hospital, professor of Neurology at Harvard Medical School and lead author of the study publication, said that these results show that Epidiolex may provide clinically meaningful benefits for patients with LGS.

GW said that the study randomized 171 patients with LGS whose seizures were not controlled by their current AED regimen, to receive either Epidiolex (20mg/kg/day) or placebo in addition to existing treatment. Conducted in 24 study centers in the United States and Europe, on average, patients were taking approximately three AEDs, having previously tried and discontinued an average of six other AEDs. At baseline, patients had a median frequency of 74 drop seizures per month.

According to GW, over the 14-week treatment period (two-week dose escalation period followed by 12 weeks of maintenance), patients taking Epidiolex had a significantly greater median reduction in drop seizures compared to placebo: 44%:22%.

Adverse Events, one study unrelated dead

Furthermore, GW explained that the most common adverse events (AEs) (>10 percent) were diarrhea, somnolence, pyrexia, decreased appetite and vomiting. Overall, 86 percent of patients taking Epidiolex and 69 percent of patients taking placebo experienced an AE, and most were mild or moderate. Of those patients who experienced AEs, the events resolved by the end of the trial for 61 percent of Epidiolex patients and 64 percent of placebo patients.

Twenty patients on Epidiolex experienced serious AEs, including one fatal case of acute respiratory distress syndrome, for which GW said it was considered unrelated by the Investigator, compared with four patients with serious AEs on placebo. Twelve patients taking Epidiolex discontinued treatment due to AEs compared with one patient taking placebo.

Across the Epidiolex development program, the most common reported adverse reactions are somnolence, decreased appetite, diarrhea, pyrexia, fatigue, lethargy, rash, nasopharyngitis, and pneumonia; dose-related reversible elevation of liver transaminases without elevation of bilirubin were also observed.

“Uncontrolled seizures significantly impact the lives of patients and their families and there is a tremendous need for new options in difficult-to-treat epilepsies such as LGS,” said Philip Gattone, president and CEO, Epilepsy Foundation. “This randomized, controlled clinical study provides positive evidence of the potential role of cannabidiol in reducing seizures and we are excited about the possibility of a new treatment option for LGS.”