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Research has shown that Epidiolex-based cannabidiol is effective in significantly reducing epileptic seizures that are difficult to treat. Patients over two years of age with Dravet and Lennox-Gastaut syndrome experienced a 50% decrease in seizure frequency. ( Greenwich Biosciences, Inc. )
People with a rarer and more serious form of epilepsy called Dravet syndrome have shown a significant decrease in the number of seizures after taking Epidiolex, a cannabis-based substance.
In 2018, the US Food and Drug Administration approved Epidiolex for the treatment of Dravet and Lennox-Gastaut syndromes in children over 2 years of age. This is the first time the agency has approved a purified marijuana drug as well as Dravet Syndrome.
Promising results
The results of the phase 3 clinical trial showed that a lower dose, 10 mg per kilogram of body weight taken daily, had the same efficacy as the 20 mg dose. The only difference between the new test and the 2017 document published in the New England Journal of Medicine is the dosage.
A total of 199 children with Dravet syndrome took the drug infused with cannabidiol, a non-psychoactive compound found in cannabis. In 14 weeks, the 20 mg group had 47% fewer seizures and 46% fewer convulsions with seizures.
The group with only 10 milligrams of Epidiolex had 56% fewer seizures and 49% fewer seizures. The frequency of seizures in the placebo group decreased by 30%, while seizures decreased by 27%.
"I was personally surprised to see such a potent treatment effect with a lower dose," said co-author Dr. Ian Miller of Nicklaus Children's Hospital in Miami, Florida. "Side effects are less common at the lower dose, and this study warrants trying patients at the lowest dose first to evaluate the efficacy and tolerability."
Miller said that increasing the dose to more than 10 milligrams per kilogram per day should be the subject of careful evaluation in terms of effectiveness and safety for each patient. The drug cannabidiol caused a lack of appetite, fever, diarrhea and fatigue in approximately 7% of participants.
Tolerance to medication
Both doses of CBD were found to be nearly as effective, but the new study showed that a lower dose of CBD was better tolerated. However, an Israeli study of 92 children and adults with different forms of epilepsy revealed that the benefits of Epidiolex seemed to fade over time.
The researchers found that about one-third of the patients exhibited tolerance to the drug after an average of seven months. Doctors had to increase the dose to 30% to achieve the same effect of reducing seizures.
FDA approval means that patients in all states will have legal access to the drug. They can also apply for insurance coverage for the medication. Miller and colleagues will present the details of the Phase 3 clinical trial at the annual meeting of the American Epilepsy Society in December.
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