Long-Term Data Reveal CBD Treatment Linked to Significant Reductions in Focal-Onset Seizures

The use of cannabidiol (CBD) was associated with reductions in focal-onset seizure, including focal aware seizures (FAS), focal impaired awareness seizures (FIAS), and focal to bilateral tonic-clonic seizures (FBTCS), with an acceptable safety profile. These results of an analysis of a study population from an expanded access program (EAP) were presented at the American Academy of Neurology (AAN) 2024 Annual Meeting.

The study included a total of 892 EAP patients, of whom 351 experienced focal-onset seizures. Patients were treated with Epidiolex (cannabidiol; Greenwich Biosciences, Carlsbad, CA) starting at 2–10 mg/kg/d and titrated to a maximum of 25–50 mg/kg/d. The median Epidiolex exposure was 684 days (range, 10 to 1793 days), with a median top dose of 25/kg/d (IQR, 24 to 31). Researchers assessed responder rates (RRs) and change from baseline in median monthly frequency of focal-onset seizures at 12-week intervals for 144 treatment weeks.

At 144 treatment weeks, the median reductions in monthly focal seizure frequency were as follows:

• FAS: 67% to 99% reduction
• FIAS: 61% to 78% reduction
• FBTCS: 50% to 81% reduction

In terms of RRs:

• FAS:
  • 61% to 88% experienced a ≥50% reduction.
  • 45% to 72% experienced a ≥75% reduction.
  • 20% to 46% experienced a 100% reduction.
• FIAS:
  • 55% to 69% experienced a ≥50% reduction.
  • 41% to 56% experienced a ≥75% reduction.
  • 18% to 29% experienced a 100% reduction.
• FBTCS:
  • 52% to 69% experienced a ≥50% reduction.
  • 41% to 54% experienced a ≥75% reduction.
  • 23% to 36% experienced a 100% reduction.

Of those with focal seizures, 90% reported adverse events (AEs) and 38% reported serious AEs; 7 participants withdrew due to AEs and there were 5 deaths that were not treatment-related.

The study authors are affiliated with Jazz Pharmaceuticals, PANDA Neurology, and the Medical College of Georgia at Augusta University.