Significant seizure reductions in patients with LGS

Significant seizure reductions in patients with LGS

EPIDIOLEX®
(cannabidiol) Cannabidiol CV Symbol
significantly improved control of seizures in highly refractory patients with LGS1

REDUCTION IN MONTHLY FREQUENCY OF DROP SEIZURES1

Epidiolex Clinical Trial Study for Lennox Gastaut Syndrome (LGS) - Percentage reduction in drop seizures with Epidiolex Epidiolex Clinical Trial Study 1 for Lennox Gastaut Syndrome (LGS) - Percentage reduction in drop seizures with Epidiolex Epidiolex Clinical Trial Study 2 for Lennox Gastaut Syndrome (LGS) - Percentage reduction in drop seizures with Epidiolex

Patients had failed a median of 6 prior AEDs and were currently uncontrolled with a median of 3 current AEDs2,3

Results from the 14-week treatment period. Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led to or could have led to a fall or injury.1-3

See baseline demographics

Reductions in drop seizure frequency were reported as early as Day 8 in a post-hoc analysis of the LGS clinical trials4

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

REDUCTION IN MONTHLY FREQUENCY OF DROP AND NON-DROP SEIZURES1

Epidiolex Clinical Trial Study for Lennox Gastaut Syndrome (LGS) - Percentage reduction in total seizures with Epidiolex Epidiolex Clinical Trial Study 1 for Lennox Gastaut Syndrome (LGS) - Percentage reduction in total seizures with Epidiolex Epidiolex Clinical Trial Study 2 for Lennox Gastaut Syndrome (LGS) - Percentage reduction in total seizures with Epidiolex

Results from the 14-week treatment period. Total seizures included drop and non-drop seizures. The baseline frequency of total seizures (median) in Study 1 was 177 in the placebo group and 145 in the EPIDIOLEX 20 mg/kg/day group. In Study 2, the baseline frequency of total seizures (median) was 181 in the placebo group, 165 in the EPIDIOLEX 10 mg/kg/day group, and 174 in the EPIDIOLEX 20 mg/kg/day group.2,3

EPIDIOLEX cut seizure frequency by ≥50% in more patients than placebo in LGS trials2

RESPONDER RATES (≥50% REDUCTION IN DROP SEIZURES FROM BASELINE) IN LGS STUDY 22

Epidiolex Lennox Gastaut Syndrome (LGS) - Patient Responder Rates with Epidiolex Epidiolex Lennox Gastaut Syndrome (LGS) - Patient Responder Rates with Epidiolex (≥50% Reduction in Drop Seizures) Epidiolex Lennox Gastaut Syndrome (LGS) - Patient Responder Rates with Epidiolex (≥75% Reduction in Drop Seizures)

Results from the 14-week treatment period. 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.1

In LGS Study 13:

  • 44% of EPIDIOLEX 20 mg/kg/day patients achieved ≥50% reduction in seizures (vs 24% on placebo)
  • 20% of EPIDIOLEX 20 mg/kg/day patients achieved ≥75% reduction (vs 8% on placebo)

More patients achieved seizure freedom with EPIDIOLEX than placebo1

Freedom from drop seizures in the maintenance period1

0.6%

Placebo

4%

EPIDIOLEX
10 mg/kg/day

5%

EPIDIOLEX
20 mg/kg/day

EPIDIOLEX provided a sustained reduction of drop seizures in patients with LGS5

REDUCTION IN FREQUENCY OF MONTHLY DROP SEIZURES to 72 WEEKS5,6

Epidiolex Lennox Gastaut Syndrome (LGS) - Sustained Drop Seizure Reduction Week 1 to 72 Epidiolex Lennox Gastaut Syndrome (LGS) - Sustained Drop Seizure Reduction Week 1 to 72

Reductions in total seizure frequency were also maintained with long-term treatment5

99% (n=366) of patients with LGS who completed controlled clinical trials chose to continue into the open-label extension study5

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 80%.5

  • LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency5
  • 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 possible1,5
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 syndrome5
  • Five deaths were reported in patients with LGS; none were deemed treatment-related by the investigator5

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, Patel AD, Cross JH, et al. N Engl J Med. 2018;378(20):1888-1897. 3. Thiele EA, Marsh ED, French JA, et al. Lancet. 2018;391(10125):1085-1096. 4. 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. 5. Patel A, Gil-Nagel A, Chin R, et al. Poster presented at: American Epilepsy Society Annual Meeting; November 30-December 4, 2018; New Orleans, LA. 6. Data on file. Greenwich Biosciences, Inc., Carlsbad, CA.