Cannabidiol linked to significant seizure reduction in focal-onset epilepsy

Key takeaways:

• Cannabidiol treatment was associated with median reduction of 67% to 99% in focal aware seizures.
• All participants, regardless of seizure type, experienced at least a 50% reduction at 144 weeks.

DENVER — Treatment with cannabidiol led to significant seizure reduction in those with focal-onset epilepsy and demonstrated a favorable safety profile, according to research presented at the American Academy of Neurology annual meeting.

“Four-year [Expanded Access Program] results demonstrated that [cannabidiol] was associated with sustained seizure improvement in [treatment-resistant epilepsy],” Karthik Rajasekaran, PhD, associate medical director of epilepsy at Jazz Pharmaceuticals, and colleagues wrote.

Rajasekaran and fellow researchers sought to report long-term safety and efficacy of cannabidiol (CBD) administration in those enrolled within the Expanded Access Program who were diagnosed with focal-onset seizures, including focal aware seizures (FAS), focal impaired awareness seizures (FIAS) and focal to bilateral tonic-clonic seizures (FBTCS).

A total of 892 participants (mean age 15.8 years; 51% male) received plant-derived highly purified cannabidiol (Epidiolex, 100 mg/mL oral solution) at 35 epilepsy centers across the United States between January 2014 and January 2019.

Administration was initiated at 2 mg/kg to 10 mg/kg per day and was subsequently titrated to a maximum of 25 mg/kg to 50 mg/kg per day.

The primary outcome of interest was percentage change from baseline in median monthly frequency of focal seizures and responder rates across 12-week intervals through 144 weeks of treatment.

From the initial cohort, 238 participants completed the study, with 113 withdrawing due to lack of efficacy.

According to results, CBD treatment was associated with median reduction of 67% to 99% for FAS, 61% to 78% for FIAS and 50% to 81% for FBTCS.

Data also showed that median percent reduction from baseline in focal seizures for all types was 62% to 76%, while all patients, regardless of seizure type, had at least 50% reduction.

Among patients with any focal seizure, 90% reported adverse events, and 38% of those were deemed serious, while 7% withdrew due to adverse events. The most common adverse events were diarrhea, convulsions and somnolence. Five deaths, not related to treatment, were recorded in the cohort.

“These results suggest that [cannabidiol] may be effective against focal onset seizures regardless of epilepsy diagnosis,” Rajasekaran said during the presentation.