Significant seizure reductions in patients with TSC

EPIDIOLEX®
(cannabidiol)
significantly reduced the frequency of TSC-associated seizures by half1

EPIDIOLEX®
(cannabidiol)
significantly reduced the frequency of TSC-associated seizures by half1

EPIDIOLEX Tuberous sclerosis complex (TSC) – Percentage Reduction in Monthly Seizure Frequency vs Placebo

*The median percent change from baseline for patients with TSC was 43% for patients receiving EPIDIOLEX 25 mg/kg/day, compared with 20% for patients receiving placebo (P<0.01).

Results from the 16-week treatment period. Primary endpoint seizures included all countable TSC-associated seizures, including partial-onset seizures and generalized seizures (tonic-clonic, tonic, clonic, or atonic).1

Patients at baseline1,2:

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

89% of patients were taking ≥2 AEDs at baseline and still experiencing 57 TSC-associated seizures per 28 days3

Venn Diagram Icon

The most commonly used concomitant AEDs were1:
45% valproate
33% vigabatrin
29% levetiracetam
27% clobazam

See baseline demographics



Results from the 16-week treatment period. Primary endpoint seizures included all countable TSC-associated seizures, including partial-onset seizures and generalized seizures (tonic-clonic, tonic, clonic, or atonic).1

*The median percent change from baseline for patients with TSC was 43% for patients receiving EPIDIOLEX 25 mg/kg/day, compared with 20% for patients receiving placebo (P<0.01).

Reductions in TSC-associated seizure frequency were reported as early as Day 6 in a post-hoc analysis of the TSC clinical trial4

The recommended maintenance daily dosage for EPIDIOLEX is 25 mg/kg/day for patients with TSC.1

Patients with moderate to severe hepatic impairment require a dose adjustment.

See recommended
dosing information
EXPAND ALL

EPIDIOLEX reduced TSC-associated partial-onset seizure score by 46% in a prespecified exploratory analysis3

EPIDIOLEX Tuberous sclerosis complex (TSC) – Percentage Reduction in Frequency vs Placebo

Composite score is a weighted average of the 3 types of partial-onset seizures included in the primary endpoint2,3,5:

  • Simple partial seizures
  • Complex partial seizures
  • Secondary generalized tonic-clonic seizures

Results from the 16-week treatment period. Results of the composite seizure score were not controlled for multiplicity; therefore, P-values are not reported.2,3

More patients with TSC achieved ≥50% and ≥75% reductions in TSC-associated seizures with EPIDIOLEX than with placebo1

EPIDIOLEX Tuberous sclerosis complex (TSC) – Percentage responders achieved reductions in seizures vs Placebo

Results from the 16-week treatment period.

More patients achieved seizure freedom with EPIDIOLEX than with placebo1

Freedom from TSC-associated seizures in the 12-week maintenance period

0%

Placebo

5%

EPIDIOLEX
25 mg/kg/day

PRESPECIFIED EXPLORATORY ENDPOINT: CHANGE IN MEAN NUMBER OF TSC-ASSOCIATED SEIZURE-FREE DAYS/28 DAYS3†

Baseline
(per 28 days)
Maintenance period
(per 28 days)
EPIDIOLEX 25 mg/kg/day, n=75 7.4 days 14.7 days 97% increase
Placebo, n=76 7 days 10.9 days 55% increase
Placebo,
n=76
EPIDIOLEX
25 mg/kg/day,
n=75
Baseline
(per 28 days)
7
days
7.4
days
Maintenance
period
(per 28 days)
10.9
days

55%
increase
14.7
days

97%
increase

Analysis was not controlled for multiplicity and is considered exploratory in nature.

EPIDIOLEX maintained reductions in TSC-associated seizures in an ongoing open-label extension trial6

EPIDIOLEX Tuberous sclerosis complex (TSC) – Percentage Responders Who Maintained Reductions in Seizures in an Ongoing Open-Label Extension Trial

Decreasing N-values reflect rolling entry into the open-label extension6

  • The retention rate at 48 weeks was 79%3
  • 28% (n=11) of withdrawals were due to adverse reactions6
  • LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency6
99% (n=199) of patients with TSC who completed the controlled trial elected to continue into the open-label extension6

Adverse events6

  • The long-term safety profile of EPIDIOLEX in this open-label extension trial was generally similar to that observed in the 16-week trial for TSC
  • There was 1 death reported during the study, which was deemed unrelated to treatment by the investigator
  • In the open-label extension trial, titration to doses over 25 mg/kg/day was permitted. At higher doses, an increase in adverse reactions is possible
See recommended dosing information
LGS 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