A new class of drugs for epilepsy based on an ingredient derived from marijuana may be available as early as the second half of 2018 in the United States pending approval by the Food Administration. and Medications.
Officials at GW Pharmaceuticals, the company that developed the drug, on Wednesday announced promising results from a study of 171 randomized patients in treatment and placebo groups. The members of the group, between 2 and 55 years of age, have a condition called Lennox-Gastaut syndrome and had seizures that were not controlled by existing medications. On average, they had tried and stopped six anticonvulsant treatments and had 74 epileptic seizures per month. Epileptic seizures affect the entire body, trunk or head and often cause a fall or other type of injury.
The results, published in The Lancet, show that during a 14-week treatment period, 44 percent of patients taking the drug, called Epidiolex, produced a significant reduction in seizures, compared with 22 percent of the placebo group. In addition, more of the patients who received the medication experienced a 50 percent or greater reduction in seizures per gout.
Elizabeth Thiele, director of pediatric epilepsy at Massachusetts General Hospital and lead author of the study, said the results vary by patient.
"For some it does not do much, but for the people where it does work, it's priceless," he said.
"A child who comes to mind had multiple attacks per day, she had taken all possible medications," said Thiele, a professor of neurology at Harvard Medical School. Then, the patient tried the cannabis-based treatment and has been free of attacks for almost four years. "She's now talking about college options, she would never have had that conversation before, life has changed."
Epidiolex is based on a purified cannabidiol, a marijuana plant oil that has made headlines in recent years. It all started when Paige Figi, a Colorado mom, started writing about how an extract, nicknamed "Charlotte's web," had almost halted her daughter's convulsions. Numerous families moved to the state, where marijuana is legalized, to try to receive treatment, and others moved into their own states to try to obtain permission to import it.
Despite its apparent effect, the Charlotte website has been controversial due to the lack of supervision and regulation regarding production, sales and dosing. The oil was produced by a small company run by brothers who grow cannabis plants. Epidiolex is meant to be a prescription medication dispensed by doctors.
"As a pharmaceutical product, it is subjected to rigorous and intense manufacturing controls, patients have the reassurance that the product is what we say it is and what it thinks it is," said Justin Gover, CEO of GW. In an interview. He declined to discuss the price of the drug, but said the company is already in talks with health insurers about coverage.
A previous study, published in the New England Journal of Medicine in May, showed that Epidiolex also appears to be safe and effective in children suffering from Dravet Syndrome, a rare and severe form of epilepsy.
Epidiolex is somewhat unusual in the developing drug world because about 1,500 people are already taking the drug under the "compassionate use" of the FDA "Exception, which allows products to be used in limited ways before be approved.
GW Pharmaceuticals said it also has a new drug application pending with the European Medicines Agency.
Dravet Syndrome: Marijuana extract drastically reduces Seizures in severe form of epilepsy
2014: "Mommy lobby" emerges as a powerful advocate of marijuana-based treatment for children
A family of doctors helps reinvent medical marijuana