TSC-ASSOCIATED SEIZURE REDUCTION
EPIDIOLEX® (cannabidiol) significantly reduced the frequency of TSC-associated seizures by half
Reduction in monthly frequency of TSC-associated seizures
Results from the 16-week treatment period. Primary endpoint seizures included all countable TSC-associated seizures, including partial-onset† seizures and generalized seizures (tonic-clonic, tonic, clonic, or atonic).
*The median percent reduction from baseline for patients living with TSC was 43% for patients receiving EPIDIOLEX 25 mg/kg/day, compared with 20% for patients receiving placebo (P<0.01).
†Partial-onset seizures (focal) included simple partial seizures (focal motor seizure), complex partial seizures (focal impaired), and secondary generalized tonic-clonic seizures (focal to bilateral tonic-clonic).1
Patients at baseline2:
- Had previously tried a median of 4 prior ASMs
- Currently uncontrolled with a median of 3 current ASMs
89% of patients were taking ≥2 ASMs at baseline and still experiencing 57 TSC-associated seizures per 28 days.2
The most commonly used concomitant ASMs were:
45% valproate|
33% vigabatrin|
29% levetiracetam|
27% clobazam
Reductions in TSC-associated seizure frequency were reported as early as Day 6 in a post hoc analysis of the TSC clinical trial.3
The recommended maintenance daily dosage for EPIDIOLEX is 25 mg/kg/day for patients living with TSC.
Patients with moderate to severe hepatic impairment require a dose adjustment.
TSC-ASSOCIATED PARTIAL-ONSET SEIZURES
EPIDIOLEX® (cannabidiol) reduced TSC-associated partial-onset seizure score by 46% in a prespecified exploratory analysis4
Reduction in monthly composite partial-onset seizure score
Results from the 16-week treatment period. Results of the composite seizure score were not controlled for multiplicity; therefore, P-values are not reported.2,4
RESPONDER RATES AND SEIZURE FREEDOM
More patients living with TSC achieved ≥50% and ≥75% reductions in TSC-associated seizures with EPIDIOLEX® (cannabidiol) than with placebo
Responder rates (≥50% and ≥75% reductions in TSC-associated seizures from baseline)6
Results from the 16-week treatment period.
More patients achieved freedom from TSC-associated seizures with EPIDIOLEX.
6%
EPIDIOLEX
25 mg/kg/day
0%
PLACEBO
Prespecified exploratory endpoint: Change in mean number of TSC-Associated seizure-free days4*
| Baseline (per 28 days) |
Maintenance period (per 28 days) |
Percent increase | |
| EPIDIOLEX 25 mg/kg/day n=71 |
7.4 days | 14.7 days | 97% |
| PLACEBO n=76 |
7 days | 10.9 days | 55% |
| EPIDIOLEX 25 mg/kg/day n=71 |
PLACEBO n=76 |
|
| Baseline (per 28 days) |
7.4 days | 7 days |
| Maintenance period (per 28 days) |
14.7 days | 10.9 days |
| Percent increase | 97% | 55% |
*Analysis was not controlled for multiplicity and is considered exploratory in nature.4
3-YEAR OPEN-LABEL EXTENSION
3-year sustained reduction of TSC-associated seizures7
Open-label extension: Reduction in monthly frequency of TSC-associated seizures7
WEEKS
Decreasing n-values reflect a combination of discontinuations and rolling entry into the open-label extension trial.7
- Patients received treatment in the open-label extension for a maximum of 1 year, except in the United States and Poland, where patients could continue beyond 1 year7
- The majority of those eligible transitioned to a commercially available product7
Adverse events:
- The long-term safety profile of EPIDIOLEX® (cannabidiol)in this open-label extension trial was generally similar to that observed in the EPIDIOLEX clinical development program7
- There was 1 death reported during the study, which was deemed unrelated to treatment by the investigator7
- In the open-label extension trial, titration to doses over 25 mg/kg/day was permitted. At higher doses, an increase in adverse reactions was observed7
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