A Fresno, CA. pediatric epilepsy patient’s seizures are reportedly controlled by a marijuana extract. The pharmaceutical version, Epidiolex, passed a pivotal trial, according to reports. (Photo courtesy of Jason David)
The compounds in marijuana seem to treat devastating seizures in children, another study today confirmed, causing the price of shares in the company that makes the drug to double.
UK company GW Pharmaceutical announced today that its marijuana-derived drug Epidiolex reduced untreatable seizures by an average of 39 percent in a major, placebo-controlled trial. GW’s stock doubled today on the news.
A 120-patient trial of the pot extract rich in the molecule cannabidiol (CBD) passed the first of four, final trials for the drug, which could have a market of $1.1 billion, experts forecast.
GW’s Epidiolex appears to significantly reduce the seizures of Dravet Syndrome — a rare, often catastrophic, untreatable epilepsy.
The pot compound worked where pills failed, the study noted. On average, patients in the study had tried and failed four other current anti-epileptic drugs. The patients’ average age was 10 years old.
“In this study, patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39 percentcompared with a reduction on placebo of 13 percent, which was highly statistically significant (p=0.01). … The difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period.”
Epidiolex could still be years from the market. Meanwhile, patients and caregivers are not waiting. Medical marijuana formulations rich in CBD are widely available in California and other states with robust medical cannabis industries, but remain rare elsewhere.
Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center said patients are one step closer to having a pharmaceutical industry version of medical marijuana first legalized in California in 1996.
“These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future,” he stated.
“Dravet syndrome is one of the most catastrophic types of epilepsy in children and safe and effective treatments are desperately needed. We are thrilled to learn of these positive results, which bring much needed hope to the children and families who have been living with these debilitating seizures,” said Mary Anne Meskis, Executive Director of the Dravet Syndrome Foundation.
The marijuana extract is no silver bullet. Eight patients quit the trial due to adverse effects versus one who quit from adverse effects of the placebo. The most common side effects were mild, the study noted.
“The most common adverse events (occurring in greater than ten percent of Epidiolex-treated patients) were: somnolence, diarrhea, decreased appetite, fatigue, pyrexia, vomiting, lethargy, upper respiratory tract infection and convulsion. Of those patients on Epidiolex that reported an adverse event, 84 percent reported it to be mild or moderate,” GW Pharmaceuticals stated.