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
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
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 recommendeddosing information
EPIDIOLEX cut seizure frequency by ≥50% and ≥75% in more patients with Dravet syndrome than placebo1
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
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- LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency
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
EPIDIOLEX is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product