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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 EPIDIOLEX significantly reduced drop seizure frequency in patients living with LGS, See Important Safety Information Lennox Gastaut Syndrome, LGS - Legend for Patient Responder Rates with EPIDIOLEX

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

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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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Efficacy of EPIDIOLEX and clobazam in LGS

Drop seizure reduction in patients with LGS taking concomitant clobazam was evaluated in a prespecified exploratory analysis4

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Dosing and administration

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Efficacy of EPIDIOLEX and clobazam in LGS Dosing and administration

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 EPIDIOLEX significantly reduced drop seizure frequency in patients living with LGS Clinical Trial Study for Lennox Gastaut Syndrome, LGS - Percentage reduction in total seizures with EPIDIOLEX

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 Lennox Gastaut Syndrome, LGS - Patient Responder Rates with EPIDIOLEX Lennox Gastaut Syndrome, LGS - Legend for Patient Responder Rates with EPIDIOLEX

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

WEEKS

Epidiolex Dravet Syndrome - Patient Responder Rates with Epidiolex (≥50% Reduction in Convulsive Seizures)
Epidiolex Dravet Syndrome - Patient Responder Rates with Epidiolex (≥50% Reduction in Convulsive Seizures)
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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

99% (n=366)

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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