Jump to section:

Significant seizure reductions in patients living with TSC

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

REDUCTION IN MONTHLY FREQUENCY OF TSC-ASSOCIATED SEIZURES

EPIDIOLEX significantly reduced the monthly frequency of TSC-associated seizures, See Important Safety Information Tuberous sclerosis complex, TSC – Percentage Reduction in Monthly Seizure Frequency vs Placebo Tuberous sclerosis complex, TSC – Legend for percentage responders achieved reductions in seizures vs Placebo

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).

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

†Partial-onset seizures (focal) included simple partial seizures (focal motor seizure), complex partial seizures (focal impaired), and secondary generalized tonic-clonic seizures (focal to bilateral tonic-clonic).1

Patients at baseline2:

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

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

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

The most commonly used concomitant ASMs were:

45% valproate|

33% vigabatrin|

29% levetiracetam|

27% clobazam

Reductions in TSC-associated seizure frequency were reported as early as Day 6 in a post hoc analysis of the TSC clinical trial.3

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

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

Additional endpoints

EPIDIOLEX reduced TSC-associated partial-onset seizure score by 46% in a prespecified exploratory analysis4

REDUCTION IN MONTHLY COMPOSITE PARTIAL-ONSET SEIZURE SCORE

Chart of tuberous sclerosis complex, TSC – Percentage Reduction in Frequency vs Placebo Chart of TSC-associated partial-onset seizures in a prespecified exploratory analysis, See Important Safety Information 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 endpoint1,4,5:

  • 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.2,4

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

RESPONDER RATES (≥50% AND ≥75% REDUCTIONS IN TSC-ASSOCIATED SEIZURES FROM BASELINE)6

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

Results from the 16-week treatment period.

More patients achieved freedom from TSC-associated seizures with EPIDIOLEX.

6%

EPIDIOLEX
25 mg/kg/day

0%

PLACEBO

Prespecified exploratory endpoint: Change in mean number of TSC-Associated seizure-free days4‡

Baseline
(per 28 days)		 Maintenance period
(per 28 days)		 Percent increase
EPIDIOLEX
25 mg/kg/day
n=71		 7.4 days 14.7 days 97%
PLACEBO
n=76		 7 days 10.9 days 55%
EPIDIOLEX
25 mg/kg/day
n=71		 PLACEBO
n=76
Baseline
(per 28 days)		 7.4 days 7 days
Maintenance period
(per 28 days)		 14.7 days 10.9 days
Percent increase 97% 55%

‡Analysis was not controlled for multiplicity and is considered exploratory in nature.4

3-year sustained reduction of TSC-associated seizures7

OPEN-LABEL EXTENSION: REDUCTION IN MONTHLY FREQUENCY OF TSC-ASSOCIATED SEIZURES

Tuberous sclerosis complex, TSC – Percentage of responders who maintained reductions in seizures in an ongoing open-label extension trial for EPIDIOLEX, See Important Safety Information

WEEKS

Tuberous sclerosis complex TSC – Percentage responders who maintained reductions in seizures in an ongoing open-label extension trial/tsc-chart-3-mobile.png
Tuberous sclerosis complex, TSC – Percentage Responders Who Maintained Reductions in Seizures in an Ongoing Open-Label Extension Trial
Drag for more

Decreasing n-values reflect a combination of discontinuations and rolling entry into the open-label extension trial.7

  • Patients received treatment in the open-label extension for a maximum of 1 year, except in the United States and Poland, where patients could continue beyond 1 year7
  • The majority of those eligible transitioned to a commercially available product7
99% (n=199) of patients with TSC who completed the controlled trial elected to continue into the open-label extension.7

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 program7
  • There was 1 death reported during the study, which was deemed unrelated to treatment by the investigator7
  • In the open-label extension trial, titration to doses over 25 mg/kg/day was permitted. At higher doses, an increase in adverse reactions was observed7

Similar resources

EPIDIOLEX significantly reduced drop seizure frequency in patients living with LGS, See Important Safety Information

LGS data

EPIDIOLEX significantly reduced drop/total seizure frequency in patients living with LGS

See the data

 EPIDIOLEX significantly reduced convulsive seizures in patients living with Dravet syndrome, See Important Safety Information

Dravet syndrome data

EPIDIOLEX significantly reduced convulsive seizures in patients living with Dravet syndrome

See the data

 The safety profile of EPIDIOLEX was evaluated in an expansive clinical trial program

Safety

The safety profile of EPIDIOLEX was evaluated in an expansive clinical trial program

See the data