Significant seizure reductions in patients with LGS
EPIDIOLEX® (cannabidiol) significantly reduced seizure frequency in highly refractory patients with LGS
EPIDIOLEX® (cannabidiol) significantly reduced seizure frequency in highly refractory patients with LGS
Results from the 14-week treatment period. Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led to or could have led to a fall or injury.1,2
Patients at baseline1,2:
- Had previously tried a median of 6 prior AEDs
- Currently uncontrolled with a median of 3 current AEDs
94% of patients were taking ≥2 AEDs at baseline and still experiencing a median of 74 and 85 drop seizures (Study 1 and Study 2, respectively) per 28 days
The most frequently used concomitant AEDs across Study 1 and Study 2 were:
49% clobazam | 39% valproate | 33% lamotrigine
Reductions in drop seizure frequency were reported as early as Day 6 in a post-hoc analysis of the LGS clinical trials3
Recommended daily dosage is 10 mg/kg/day (5 mg/kg twice daily), with a maximum maintenance dosage of 20 mg/kg/day (10 mg/kg twice daily).
Administration of the 20 mg/kg/day dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions. Patients with moderate to severe hepatic impairment require a dose adjustment.
See recommended dosing informationEPIDIOLEX significantly reduced total seizures in patients with LGS
Results from the 14-week treatment period. Total seizures included drop and non-drop seizures. The baseline frequency of total seizures (median) in Study 1 was 177 in the placebo group and 145 in the EPIDIOLEX 20 mg/kg/day group. In Study 2, the baseline frequency of total seizures (median) was 181 in the placebo group, 165 in the EPIDIOLEX 10 mg/kg/day group, and 174 in the EPIDIOLEX 20 mg/kg/day group.1,2
EPIDIOLEX cut seizure frequency by ≥50% and ≥75% in more patients than
placebo in LGS trials1
Results from the 14-week treatment period. Administration of the 20 mg/kg/day dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions.
In LGS Study 12:
- 44% of EPIDIOLEX 20 mg/kg/day patients achieved ≥50% reduction in seizures (vs 24% on placebo)
- 20% of EPIDIOLEX 20 mg/kg/day patients achieved ≥75% reduction (vs 8% on placebo)
More patients achieved seizure freedom with EPIDIOLEX than placebo
Freedom from drop seizures in the maintenance period
0.6%
Placebo
4%
EPIDIOLEX
10 mg/kg/day
5%
EPIDIOLEX
20 mg/kg/day
EPIDIOLEX provided patients with LGS a sustained reduction of drop seizures over 3 years4
Decreasing N-values reflect rolling entry into the open-label extension
- Retention rates at 1, 2, and 3 years were 81%, 69%, and 65%, respectively
- 31% (n=37) of withdrawals were due to adverse reactions
- LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency
Reductions in total seizure frequency were also maintained with long-term treatment
Adverse events4
- The long-term safety profile of EPIDIOLEX in this open-label extension trial was generally similar to that in the pivotal trials for LGS, Dravet syndrome, and TSC
- Eleven deaths were reported in patients with LGS; none were deemed treatment-related by the investigator
- In the open-label extension trial, titration to doses over 20 mg/kg/day was permitted. At higher doses, an increase in adverse reactions is possible
EPIDIOLEX is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product