Prescription Cannabidiol Sustains Reductions in Seizure Frequency and Improves Function, Leading to Treatment Continuation
Results of a survey study show that 93% of caregivers for those with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) plan to continue treatment with prescription cannabidiol (CBD) (Epidiolex; Jazz Pharmaceuticals, Palo Alto, CA). In a survey of 562 caregivers, 498 of whom completed the survey, reasons for planned continuation included reduced seizure frequency (91%) and improvements in functional measures (77%).
More seizure-free days/week were reported by 67% of respondents, and 16% reported the person they cared for achieved seizure freedom in the month before the survey was completed. Reductions in health care utilization were also reported by 68% of caregivers, with 57% reporting decreased use of rescue medications, and 54%, 53%, and 48%, respectively, reporting fewer emergency department visits, hospitalizations, and injuries.
Additionally, post hoc analysis of the open-label extension study of prescription CBD for LGS showed seizure frequency reduction increased by a mean 14% after further dose titration (from 12.5 mg/kg/day to a mean 25.8 mg/kg/day.) Increased seizure frequency reduction was higher among those who had not achieved 50% or more seizure frequency reduction during the blinded portion of the study. Once effective doses were reached, a mean 65% seizure frequency reduction from baseline was maintained during 82-week open-label period.
Robert Iannone, MD, MSCE, and executive vice president of research and development and chief medical officer at Jazz Pharmaceuticals said, “Looking across the different syndromes and seizure subtypes that occur in those syndromes, which are quite distinct, we see that Epidiolex is effective for a broad range of seizure types. In addition to the data available for Epidiolex that support its approved indications to treat seizures associated with Lennox-Gastaut syndrome, Dravet syndrome (DS) and tuberous sclerosis complex, we are continuing our development with a trial announced for epilepsy with myoclonic atonic seizures (EMAS) and continued work in epilepsy at all stages, from the bench to the development of novel medications.”
Regarding functional measures, 71% of respondents reported improved alertness, awareness, and ability to learn new things. Improvements in attention, following simple instructions, and completing tasks were reported by more than half of the respondents. Caregivers also expressed that those taking prescription CBD were more able to engage with others (68%), seemed happier (64%-67%), and were more able remain calm (56%). Most, however, reported no change in uncontrollable outbursts, frustration, or seeming withdrawn. Improvements in 1 or more areas of communication were reported for both nonverbal (79%) and verbal (74%) individuals.
In the survey study, caregivers reported their impressions of individuals with mean age of 16 years (range 1-73) for all patients, 17 years (range 2-73) for LGS and 12 years (range 1-56) for DS. The treated individuals had been taking this prescription CBD for a mean 2 years with median dose of 14 mg/kg/d, and approximately half were prescribed a dose between 10 and 20 mg/kg/day.
Prescription CBD is approved by the Food and Drug administration for the treatment of seizures related to DS, LGS, and tuberous sclerosis complex (TSC). Proven effective in double-blind, randomized, placebo-controlled clinical trials, this prescription CBD differs from myriad CBD products available without a prescription, in that it is highly purified via a controlled manufacturing process to ensure consistency of dose and purity.
These data were presented at the American Epilepsy Society (AES) Annual Meeting, held December 3-7, 2021, in Chicago, Illinois and virtually through AES 2021 Digital Select.