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

Epidiolex Clinical Trial Study for Lennox Gastaut Syndrome (LGS) - Percentage reduction in drop seizures with Epidiolex Epidiolex Clinical Trial Study 1 for Lennox Gastaut Syndrome (LGS) - Percentage reduction in drop seizures with Epidiolex Epidiolex Clinical Trial Study 2 for Lennox Gastaut Syndrome (LGS) - Percentage reduction in drop seizures 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 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

See baseline demographics

Reductions in drop seizure frequency were reported as early as Day 8 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 information
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EPIDIOLEX significantly reduced total seizures in patients with LGS

Epidiolex Clinical Trial Study for Lennox Gastaut Syndrome (LGS) - Percentage reduction in total seizures with Epidiolex Epidiolex Clinical Trial Study 1 for Lennox Gastaut Syndrome (LGS) - Percentage reduction in total seizures with Epidiolex Epidiolex Clinical Trial Study 2 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. 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

Epidiolex Lennox Gastaut Syndrome (LGS) - Patient Responder Rates with Epidiolex Epidiolex Lennox Gastaut Syndrome (LGS) - Patient Responder Rates with Epidiolex (≥50% Reduction in Drop Seizures) Epidiolex Lennox Gastaut Syndrome (LGS) - Patient Responder Rates with Epidiolex (≥75% Reduction in Drop Seizures)


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

Epidiolex Lennox Gastaut Syndrome (LGS) - Sustained Drop Seizure Reduction Week 1 to 156 Epidiolex Lennox Gastaut Syndrome (LGS) - Sustained Drop Seizure Reduction Week 1 to 156 Epidiolex Lennox Gastaut Syndrome (LGS) - Sustained Drop Seizure Reduction Week 1 to 156

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

99% (n=366) of patients with LGS who completed controlled clinical trials chose to continue into the open-label extension study

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
See recommended dosing information
TSC data Dravet syndrome data

EPIDIOLEX is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product

SEE WARNINGS AND PRECAUTIONS