INSYS Therapeutics has just released data from their long-term safety study of CBD as a treatment for refractory pediatric epilepsy. The results were positive and we’re excited about the future of this treatment.
The company is now enrolling patients in three different ongoing clinical trials for CBD. These include a Phase 3 trial for infantile spasms and a Phase 2 trial for Prader-Willi syndrome. There is also a Phase 2 trial for childhood absence epilepsy whose results are expected soon.
What exactly is CBD?
CBD is a component of cannabis which is not psychoactive. It’s official name is Pharmaceutical-grade cannabidiol. The drug is administered orally. It is being investigated as a treatment for currently treatment-resistant forms of pediatric epilepsy.
The results of this most recent trial of CBD were extremely positive, giving us more hope about this new treatment. Additionally, the results were consistent with the data received from other CBD studies, further confirming the company’s findings.
Results from the safety trial
Overall, results showed that even high doses of CBD are generally well-tolerated in pediatric patients (1 to 17 years of age).
Unfortunately though, well-tolerated doesn’t mean without side effects.
The study was conducted with 52 patients from 11 states across the US. It included 9 infants, 26 children, and 17 adolescent patients. For 48 weeks, patients were given the CBD oral solution at either 10 mg, 20 mg, or 40 mg each day.
Safety was assessed primarily by the type and number of treatment-emergent adverse events or TEAEs. Physical exams and neurological exams/lab tests were also conducted at follow-up appointments. 90.4% of patients in the study had one or more TEAEs however, of these, only 46.2% were likely related to CBD. There were 278 different TEAEs reported in total, 37 of these being serious. Of the serious TEAEs, only 3 were possibly related to CBD.
“The results of this study support the promising safety profile of CBD oral solution from INSYS in the context of treating pediatric patients with intractable seizures due to epilepsy.”
25 of the patients within this trial will continue to receive CBD even after the completion of the study, ensuring the supply of an investigational drug which has the potential to change patient lives.
You can read more about this study and the currently enrolling clinical trials here.