The cannabis product was the first to receive FDA approval, and has shown significant health benefits
Dravet (DS) and Lennox-Gastaut (LGS) syndromes are two severe, treatment-refractory, pediatric-onset epileptic syndromes associated with a marked increase in mortality rates and comorbidities compared to the general population. The specialists who care for them highlight the unmet needs and the lack of specific, safe, and effective treatments for better management of the disease. Fortunately, Epidiolex has become a drug to treat these diseases effectively and safely, reducing the 50% reduction in monthly seizures observed in patients, according to real-world studies.
Before the FDA-approved Epidiolex, a cannabidiol (CBD)-based drug, it had already been proven in different studies that by administering 100% purified CBD to patients with Dravet syndrome, seizures were reduced in half of the patients. In fact, it was observed that in 5%, they were completely stopped. Very similar results were obtained in LGS.
The safety and efficacy of Epidiolex in young and adult patients with DS and LGS were supported in a real-world report, with benefits similar to those seen in previous clinical trials and expanded access programs (EAPs). This oral solution of highly purified CBD has already gained approval both inside and outside the US, as it is highly effective in preventing seizures associated with DS and LGS in young children and adults.
Researchers claim that these approvals were given thanks to positive efficacy and safety data through several clinical trials. Still, experts say that “more knowledge is needed on the most appropriate combination, dosage, and titration for CBD use.”
After retrospectively analyzing data from 102 Spanish Dravet and LGS patients treated with Epidiolex in 14 hospitals, a 50% reduction in monthly seizures could be found. “Considering most disabling seizures, the results of our study were also similar to those of an EAP conducted at 25 US centers,” the researchers wrote.