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EPIDIOLEX® (cannabidiol) is proven across a wide range of patients living with LGS, Dravet syndrome, and TSC, and with concomitant therapies

EPIDIOLEX has a breadth of data in patients living with LGS, Dravet syndrome, and TSC

Patients at baseline1-4

Median number of seizures at baseline/28 days Median number of previous ASMs Median number of current ASMs Patients taking ≥2 ASMs (%)
LGS
Study 1
(ages 2-55 years)1*		 74
(drop seizures)		 6 3 94%
LGS
Study 2
(ages 2-55 years)2*		 85
(drop seizures)		 6 3 94%
Dravet syndrome
Study 3
(ages 2-18 years)3†		 13
(convulsive seizures)		 4 3 93%
TSC
Study 4
(ages 1-65 years)4‡		 57
(TSC-associated
seizures)		 4 3 89%
LGS Study 1 (ages 2-55 years)1*
Median number of seizures at baseline/28 days 74
(drop seizures)
Median number of previous ASMs 6
Median number of current ASMs 3
Patients taking ≥2 ASMs (%) 94%
LGS Study 2 (ages 2-55 years)2*
Median number of seizures at baseline/28 days 85
(drop seizures)
Median number of previous ASMs 6
Median number of current ASMs 3
Patients taking ≥2 ASMs (%) 94%

* Eligibility criteria for age was 2-55 years. 32% of patients in LGS studies were ages 18-55. Both trials had a 4-week baseline period, during which patients were required to have a minimum of 8 drop seizures while on stable ASM therapy.1-2

Dravet syndrome Study 3 (ages 2-18 years)3*
Median number of seizures at baseline/28 days 13
(convulsive seizures)
Median number of previous ASMs 4
Median number of current ASMs 3
Patients taking ≥2 ASMs (%) 93%

* In the Dravet syndrome study, eligibility criteria for age was 2-18 years. During the 4-week baseline period, patients were required to have at least 4 convulsive seizures while on stable ASM therapy.

TSC Study 4 (ages 1-65 years)4*
Median number of seizures at baseline/28 days 57
(TSC-associated seizures)
Median number of previous ASMs 4
Median number of current ASMs 3
Patients taking ≥2 ASMs (%) 89%

* Eligibility criteria for age was 1-65 years. During the 4-week baseline period, patients were required to have a minimum of 8 TSC-associated seizures (countable focal or generalized), with at least 1 seizure per week in ≥3 of the 4 weeks while on stable ASM therapy.5

* Eligibility criteria for age was 2-55 years. 32% of patients in LGS studies were ages 18-55. Both trials had a 4-week baseline period, during which patients were required to have a minimum of 8 drop seizures while on stable ASM therapy.1-2

† In the Dravet syndrome study, eligibility criteria for age was 2-18 years. During the 4-week baseline period, patients were required to have at least 4 convulsive seizures while on stable ASM therapy.

‡ Eligibility criteria for age was 1-65 years. During the 4-week baseline period, patients were required to have a minimum of 8 TSC-associated seizures (countable focal or generalized), with at least 1 seizure per week in ≥3 of the 4 weeks while on stable ASM therapy.5

EPIDIOLEX delivers broad-spectrum efficacy to significantly reduce generalized (LGS, Dravet syndrome, and TSC) and focal (TSC) seizures

PRIMARY ENDPOINT: CHANGE (PER 28 DAYS) FROM BASELINE VS PLACEBO WHEN ADDED TO CURRENT TREATMENT

LGS

Dravet syndrome

TSC
PROVEN REDUCTIONS IN: ✔ Drop/total seizures ✔ Convulsive seizures ✔ TSC-associated seizures including partial-onset§ and generalized
PRIMARY ENDPOINT:

Drop seizures defined as seizures that led to or could have led to a fall or injury1,2:

  • Atonic
  • Tonic
  • Tonic-clonic

Convulsive seizures defined as countable3:

  • Atonic
  • Tonic
  • Tonic-clonic
  • Clonic

TSC-associated seizures defined as4:

  • Partial-onset seizures§
  • Atonic
  • Tonic
  • Tonic-clonic
  • Clonic

LGS

Drop seizures defined as seizures that led to or could have led to a fall or injury1,2:

  • Atonic
  • Tonic
  • Tonic-clonic
Efficacy in LGS

Dravet syndrome

Convulsive seizures defined as countable3:

  • Atonic
  • Tonic
  • Tonic-clonic
  • Clonic
Efficacy in Dravet syndrome

TSC

TSC-associated seizures defined as4:

  • Partial-onset seizures†
  • Atonic
  • Tonic
  • Tonic-clonic
  • Clonic
Efficacy in TSC

§†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).6

EPIDIOLEX was studied in 900 patients, the largest clinical trial program to date in LGS, Dravet syndrome, and TSC∥‡

4 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER PHASE 3 TRIALS1-4

4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trials Chart 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trials Chart

∥‡There was a second randomized controlled trial in 199 patients with Dravet syndrome that has been completed since its original approval.7

§Patients who completed the randomized controlled trials were eligible to continue in an open-label extension.1,2

Similar resources

EPIDIOLEX, cannabidiol, is indicated in patients with LGS, Dravet syndrome, and TSC 1 year and older

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

 EPIDIOLEX reduced the frequency of TSC associated seizures, See Important Safety Information

TSC data

EPIDIOLEX reduced the frequency of TSC-associated seizures

See the data