Significant seizure reductions in patients with Dravet syndrome

EPIDIOLEX®
(cannabidiol)
significantly reduced convulsive seizures in patients with Dravet syndrome

EPIDIOLEX®
(cannabidiol)
significantly reduced convulsive seizures in patients with Dravet syndrome

Epidiolex Clinical Trial Study for Dravet Syndrome - Percentage reduction in convulsive seizures with Epidiolex



Results from the 14-week treatment period. Convulsive seizures included all countable atonic, tonic, clonic, and tonic-clonic seizures.

Patients at baseline1:

  • Had previously tried a median of 4 prior AEDs
  • Currently uncontrolled with a median of 3 current AEDs

In Study 3, 93% of patients were taking ≥2 AEDs at baseline and still experiencing a median of 13 convulsive seizures per 28 days

The most frequently used concomitant AEDs were:
65% clobazam | 57% valproate | 43% stiripentol

See baseline demographics

Seizure frequency reduction was reported by Day 10 in a post-hoc analysis of the Dravet syndrome clinical trial2

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 cut seizure frequency by ≥50% and ≥75% in more patients with Dravet syndrome than placebo1

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


Results from the 14-week treatment period.

 

More patients achieved seizure freedom with EPIDIOLEX than placebo

Freedom from convulsive seizures in the maintenance period

0%

Placebo

7%

EPIDIOLEX
20 mg/kg/day

EPIDIOLEX maintained reductions in convulsive seizures for patients with Dravet syndrome over 3 years3

Epidiolex Dravet Syndrome - Sustained Convulsive Seizure Reduction Week 1 to 72 Epidiolex Dravet Syndrome - Sustained Convulsive Seizure Reduction Week 1 to 72 Epidiolex Dravet Syndrome - Sustained Convulsive Seizure Reduction Week 1 to 72

Decreasing N-values reflect rolling entry into the open-label extension

  • Retention rates at 1, 2, and 3 years were 72%, 53%, and 45%, respectively
  • 18% (n=24) of withdrawals were due to adverse reactions
  • LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency
95% (n=315) of patients with Dravet syndrome who completed controlled trials elected to continue into the open-label extension

Adverse events3

  • The long-term safety profile of EPIDIOLEX in this open-label extension trial was generally similar to that observed in the pivotal trials for LGS, Dravet syndrome, and TSC
  • Four deaths were reported in patients with Dravet syndrome, all of which were deemed unrelated to treatment 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
LGS data TSC data

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

SEE WARNINGS AND PRECAUTIONS