Significant seizure reductions in patients with Dravet syndrome

Significant seizure reductions in patients with Dravet syndrome

EPIDIOLEX®
(cannabidiol) Cannabidiol CV Symbol
significantly reduced convulsive seizures in patients with Dravet syndrome1

REDUCTION IN MONTHLY FREQUENCY OF CONVULSIVE SEIZURES1

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

Patients had failed a median of 4 prior AEDs and were currently uncontrolled on a median of 3 current AEDs2

Results from the 14-week treatment period. Convulsive seizures included all countable atonic, tonic, clonic, and tonic-clonic seizures.1

See baseline demographics

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).1

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.1

See recommended
dosing information

Convulsive seizure frequency reduction was reported as early as Day 10 in a post-hoc analysis of the Dravet syndrome clinical trial3

EPIDIOLEX cut seizure frequency by ≥50% in more patients than placebo in the Dravet syndrome trial2

RESPONDER RATES (≥50% REDUCTION IN CONVULSIVE SEIZURES FROM BASELINE)2

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

Results from the 14-week treatment period (nominal P=0.08).2

EPIDIOLEX made seizure freedom possible for more patients than placebo1

Freedom from convulsive seizures in the maintenance period1

0%

Placebo

6.7%

EPIDIOLEX
20 mg/kg/day

EPIDIOLEX maintained reductions in convulsive seizures for Dravet syndrome4

REDUCTION IN FREQUENCY OF MONTHLY CONVULSIVE SEIZURES to 72 weeks4,5

Epidiolex Dravet Syndrome - Sustained Convulsive Seizure Reduction Week 1 to 72 Epidiolex Dravet Syndrome - Sustained Convulsive Seizure Reduction Week 1 to 72
92% (n=129) of patients with Dravet syndrome who completed controlled trials elected to continue into the open-label extension study4

Decreasing patient numbers are a result of rolling entry into the clinical study and therefore the open-label extension. Retention rate for patients who could have reached 1 year was 70%.4

  • LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency4
  • 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 possible4
See recommended dosing information

Adverse events

  • The long-term safety profile of EPIDIOLEX in this open-label extension trial was generally similar to that observed in the three 14-week trials for LGS and Dravet syndrome4
  • Two deaths were reported in patients with Dravet syndrome, both of which were attributed to sudden unexplained death in epilepsy and deemed unrelated to treatment by the investigator4

LOCF=last observation carried forward.

The most common adverse reactions (≥10%; greater than placebo) were: somnolence; decreased appetite; diarrhea; transaminase elevations; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder, and poor quality sleep; and infections.

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

SEE WARNINGS AND PRECAUTIONS

References: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018. 2. Devinsky O, Cross JH, Laux L, et al. N Engl J Med. 2017;376(21):2011-2020. 3. Privitera M, Marsh E, Mazurkiewicz-Beldzinska M, et al. Poster presented at: American Epilepsy Society Annual Meeting; November 30-December 4, 2018; New Orleans, LA. 4. Scheffer IE, Halford J, Nabbout R, et al. Poster presented at: American Epilepsy Society Annual Meeting; November 30-December 4, 2018; New Orleans, LA. 5. Data on file. Greenwich Biosciences, Inc., Carlsbad, CA.