Significant seizure reductions in patients living with LGS
EPIDIOLEX® (cannabidiol) significantly reduced drop seizure frequency in patients living with LGS
REDUCTION IN MONTHLY FREQUENCY OF DROP SEIZURES
![Clinical Trial Study for Lennox Gastaut Syndrome, LGS, shows a reduction in drop seizures with EPIDIOLEX, See Important Safety Information](/themes/custom/EPIDIOLEX_hcp/images/charts/GWS22104_LGS_MonthlyDropSeizures_bargraph_v2_RGB 1.png)
![EPIDIOLEX significantly reduced drop seizure frequency in patients living with LGS, See Important Safety Information](/themes/custom/EPIDIOLEX_hcp/images/LGS-chart-1-mobile.png)
![Lennox Gastaut Syndrome, LGS - Legend for Patient Responder Rates with EPIDIOLEX](/themes/custom/EPIDIOLEX_hcp/images/LGS-chart-1-legend-mobile.png)
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 ASMs
- Currently uncontrolled with a median of 3 current ASMs
94% of patients were taking ≥2 ASMs at baseline and still experiencing a median of 74 and 85 drop seizures (Study 1 and Study 2, respectively) per 28 days.1,2
The most commonly used concomitant ASMs 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 trials.3
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.
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Additional endpoints
EPIDIOLEX significantly reduced total seizures in patients living with LGS
REDUCTION IN MONTHLY FREQUENCY OF DROP SEIZURES
![EPIDIOLEX significantly reduced drop seizure frequency in patients living with LGS, See Important Safety Information](/themes/custom/EPIDIOLEX_hcp/images/charts/GWS22104_LGS_chart2_70_RGB 1.png)
![EPIDIOLEX significantly reduced drop seizure frequency in patients living with LGS](/themes/custom/EPIDIOLEX_hcp/images/LGS-chart-2-mobile.png)
![Clinical Trial Study for Lennox Gastaut Syndrome, LGS - Percentage reduction in total seizures with EPIDIOLEX](/themes/custom/EPIDIOLEX_hcp/images/LGS-chart-2-legend-mobile.png)
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.1
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.2
EPIDIOLEX cut seizure frequency by ≥50% and ≥75% in more patients than placebo in the LGS trials
Responder rates (≥50% and ≥75% reductions in drop seizures from baseline)1,2
![EPIDIOLEX significantly reduced drop seizure frequency in patients living with LGS, See Important Safety Information](/themes/custom/EPIDIOLEX_hcp/images/charts/GWS22104_LGS_chart3_rev_full_study_1_v2_RGB 1.png)
![Lennox Gastaut Syndrome, LGS - Patient Responder Rates with EPIDIOLEX](/themes/custom/EPIDIOLEX_hcp/images/LGS-responder-rates-chart.png)
![Lennox Gastaut Syndrome, LGS - Legend for Patient Responder Rates with EPIDIOLEX](/themes/custom/EPIDIOLEX_hcp/images/LGS-chart-1-legend-mobile.png)
Results from the 14-week treatment period.1,2
More patients achieved freedom from drop seizures with EPIDIOLEX than with placebo.
4%
EPIDIOLEX
10 mg/kg/day
5%
EPIDIOLEX
20 mg/kg/day
0.6%
PLACEBO
3-year sustained reduction of drop seizures54
OPEN-LABEL EXTENSION: REDUCTION IN MONTHLY FREQUENCY OF DROP SEIZURES54
![Lennox Gastaut Syndrome, LGS - Sustained Drop Seizure Reduction Week 1 to 156 with EPIDIOLEX, See Important Safety Information](/themes/custom/EPIDIOLEX_hcp/images/charts/Rectangle 123.png)
WEEKS
![Epidiolex Dravet Syndrome - Patient Responder Rates with Epidiolex (≥50% Reduction in Convulsive Seizures)](/themes/custom/EPIDIOLEX_hcp/images/charts/lgs-chart-3-mobile-key.png)
![Epidiolex Dravet Syndrome - Patient Responder Rates with Epidiolex (≥50% Reduction in Convulsive Seizures)](/themes/custom/EPIDIOLEX_hcp/images/charts/lgs-chart-3-mobile.png)
Decreasing n-values reflect a combination of discontinuations and rolling entry into the open-label extension trial.65
- Retention rates at 1, 2, and 3 years were 81%, 69%, and 65%, respectively65
- 30% (n=37) of withdrawals were due to adverse reactions54
- LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency65
Reductions in total seizure frequency were also maintained with long-term treatment.54
of patients with LGS who completed controlled clinical trials chose to continue into the open-label extension.54
Adverse events
- The long-term safety profile of EPIDIOLEX in this open-label extension trial was generally similar to that observed in the EPIDIOLEX clinical development program54
- Eleven deaths were reported in patients with LGS; none were deemed to be treatment-related by the investigator54
- In the open-label extension trial, titration to doses over 20 mg/kg/day was permitted. At higher doses, an increase in adverse reactions was observed54
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