GW Pharmaceuticals recently announced that its drug Epidiolex, which contains an active ingredient derived from marijuana, shows promise in seizure treatment. The London-based company revealed data from 27 patients with treatment-resistant epilepsy that have been taking its cannabidiol drug for at least 12 weeks. Cannabidiol is just one of the many cannabinoids in marijuana. It is a purified liquid extract of cannabis that does not cause highs.
Epilepsy is a neurological disorder that causes seizures. Seizures are episodes when neurons in the brain send out the wrong signals and can range from mild to severe.
Of the 27 patients, 26 were between ages 3 and 16, with the average age of 10.5 years. The one other patient was 26-years-old. They are plagued with more difficult seizures caused by different types of severe epilepsy such as Dravet syndrome and Lennox-Gastaut syndrome, which cannot be controlled by current medications.
The treatments were conducted at the University of California in San Francisco and the New York University Langone Medical Center. Two of the 27 patients began treatment in 2013, and the other 25 patients began treatment in early 2014.
Forty-eight percent of the patients had a reduction in seizures by at least 50 percent, 41 percent had a reduction of at least 70 percent, and 22 percent of the patients had at least a 90 percent decrease in their seizure frequency. Fifteen percent of all the patients were seizure free at the end of 12 weeks. In all patients, Epidiolex was added to their current anti-epileptic drug (AED) regimen.
The drug Epidiolex shows special promise for many, despite it being derived from marijuana, including those like Valerie Weaver who have been waiting for a breakthrough in the treatment of severe seizure disorders. Weaver’s young son has Lennox-Gastaut syndrome which causes him to suffer 80 seizures a day, despite his current treatment, which includes seven medications. She became interested in cannabidiol when she heard about children’s seizures being vastly reduced by it. Weaver said she was hoping for these kind of results. “I’m very, very excited,” she explained.
Dr. Orrin Devinsky admits that there is a huge unmet need in many epilepsy syndromes that affect about 750,000 Americans. Because high doses of anti-epileptic medications are unable to help frequent seizures, “some of the greatest needs are in children with severe epilepsy syndromes,” said Dr. Devinsky. He also said that the results of the study are “encouraging.”
Nine of the 27 patients suffer from Dravet syndrome, with those patients ranging from 3-years-old to 16 years. Dravet syndrome is a rare and severe form of epilepsy that begins in infancy. Children with this form of epilepsy have a higher incidence of sudden unexplained death in epilepsy (SUDEP), and have other conditions associated with the disorder. Some of these conditions related to Dravet syndrome include problems sleeping, developmental delays, balance and movement issues, nutritional problems, behavioral delays, and chronic infections. The FDA only includes convulsive seizures when assessing primary efficacy for this epileptic syndrome. Fifty-six percent of these patients who took Epidiolex had at least a 50 percent decrease in frequency of seizures as compared to baseline seizure frequency, 44 percent had at least a 70 percent reduction, and 33 percent obtained at least a reduction of 90 percent. Thirty-three percent of Dravet syndrome patients taking Epidiolex were seizure-free after 12 weeks.
Although the drug is derived from marijuana, Epidiolex is being fast-tracked through the U.S. drug approval system, and the promising results that it has shown in seizure treatment are encouraging. GW Pharmaceutical CEO Justin Glover is looking forward to commencing a Phase 2/3 clinical trial of the drug in Dravet syndrome later this year.
By Twanna Harps