EFFICACY

XCOPRI efficacy data for partial-onset seizure reduction

ZERO seizures with XCOPRI is possible1

In a study of adult patients with a median of 9 seizures/28 days at baseline

Primary
Outcome

Patients experienced up to 2x greater seizure reduction with XCOPRI compared with placebo (55% XCOPRI 400 mg, 55% XCOPRI 200 mg, 36% XCOPRI 100 mg vs 24% placebo)1

XCOPRI Logo with a wide white border

AS MANY AS 1 IN 5 PATIENTS EXPERIENCED ZERO SEIZURES1

Secondary
Outcome

Percentage of patients who achieved seizure reductions of 100%
(12-week, maintenance phase)1,2

Study Population
Study Design
Study 1
First 4 Weeks Results

Zero seizure rates achieved within the first 4 weeks and increased over time

Post-hoc analysis of an open-label study: Percentage of patients with 1-2 seizures/28 days at baseline who achieved zero seizures during first 4 weeks1

Graph showing percentage of XCOPRI patients achieving zero seizures in first 4 weeks with dosage increasing over time

Weeks of titration

Limitations

This post-hoc analysis of an open-label study of XCOPRI did not include a control arm. These data are descriptive and representative of an enriched population with a relatively small number of patients. Appropriate multiplicity adjustments were not applied.

Study Design
Pivotal Trial Results
Long-term Results

Long-term zero seizure rates for 12 months or longer

Post-hoc analysis of an open-label study: Patients with 1-2 seizures/28 days at baseline who achieved zero seizures for ≥12 months1

Icon representing 1 to 3 concomitant anti seizure medications not controlling seizures at baseline
Icon representing 1 to 3 concomitant anti seizure medications not controlling seizures at baseline

Limitations

This post-hoc analysis of an open-label study of XCOPRI did not include a control arm. These data are descriptive and representative of an enriched population with a relatively small number of patients. Appropriate multiplicity adjustments were not applied.

Study Design
First 4 Weeks Results
Seizure Reduction

Significant seizure reduction with XCOPRI

Secondary
Outcome

Percentage of patients who achieved seizure reductions
of ≥50%, ≥75%, and ≥90% (12-week, maintenance phase)1,2

Study Population
Study Design

Demonstrated to be effective in multiple types of partial-onset seizures2-4

XCOPRI demonstrated reductions in seizure frequency across multiple types of partial-onset seizures compared with placebo2-4

Secondary
Outcome

Median percentage reduction in 28-day seizure frequency in partial-onset seizure subtypes (12-week, maintenance phase)2,3

PARTIAL-ONSET
SEIZURE SUBTYPE

Placebo

XCOPRI
100 mg/day

XCOPRI
200 mg/day

XCOPRI
400 mg/day

Simple partial
seizures*†

11%

(n=17)

49%

(n=21)

62%

(n=24)

69%

(n=20)

Complex partial
seizures*

29%

(n=87)

32%

(n=95)

55%

(n=87)

62%

(n=86)

Secondary generalized
tonic-clonic seizures*

33%

(n=43)

51%

(n=34)

92%

(n=32)

83%

(n=36)

*Partial-onset=focal; simple partial=focal aware; complex partial=focal unaware; secondary generalized tonic-clonic=focal to bilateral tonic-clonic.5
†Only patients with simple partial motor seizures were included in the study.
Placebo Information
Study Design
Long-term Results

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References: 1. XCOPRI [package insert]. Paramus, NJ: SK Life Science, Inc. 2. Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020;19(1):38-48. 3. Chung SS, French JA, Kowalski J, et al. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020;94(22):e2311-e2322. 4. Data on file. SK Life Science, Inc.
Reference: 1. Aboumatar S, Biton V, Wechsler R, Ferrari L, Rosenfeld WE. Post hoc analysis of a phase 3 study for treatment of uncontrolled focal seizures: adjunctive cenobamate dose and seizure reduction by baseline seizure frequency. Epilepsy Res. 2022;186:107014.
Reference: 1. Aboumatar S, Biton V, Wechsler R, Ferrari L, Rosenfeld WE. Post hoc analysis of a phase 3 study for treatment of uncontrolled focal seizures: adjunctive cenobamate dose and seizure reduction by baseline seizure frequency. Epilepsy Res. 2022;186:107014.
References: 1. XCOPRI [package insert]. Paramus, NJ: SK Life Science, Inc. 2. Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020;19(1):38-48. 3. Krauss GL, Klein P, Brandt C, et al. Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol. 2020;19(suppl):S1-S7. 4. Chung SS, French JA, Kowalski J, et al. Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology. 2020;94(22):e2311-e2322. 5. Fisher RS, Cross JH, French JA, et al. Operational classification of seizure types by the International League Against Epilepsy: position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58(4):522-530.

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INDICATION

XCOPRI® (cenobamate tablets) CV is indicated for the treatment of partial‑onset seizures in adult patients.

Important Safety Information
and indication

CONTRAINDICATIONS
XCOPRI® is contraindicated in any patients with known hypersensitivity to the compound or any of the components of the drug product.
XCOPRI is contraindicated in patients with Familial Short QT syndrome.

Close IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION and INDICATION for XCOPRI® (cenobamate tablets) CV

CONTRAINDICATIONS

XCOPRI is contraindicated in any patients with known hypersensitivity to the compound or any of the components of the drug product.

XCOPRI is contraindicated in patients with Familial Short QT syndrome.

WARNINGS AND PRECAUTIONS

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Also known as Multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including XCOPRI. DRESS has been reported, including one fatality, when XCOPRI is titrated rapidly (weekly or faster titration). No cases of DRESS were reported in an open-label safety study of 1339 partial-onset seizure patients when XCOPRI was initiated at 12.5 mg/day and titrated every two weeks. This finding does not establish that the risk of DRESS is prevented by a slower titration; however, XCOPRI should be initiated at 12.5 mg once daily and titrated every two weeks. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement. Eosinophilia is often present. If such signs or symptoms are present, the patient should be evaluated immediately. XCOPRI should be discontinued immediately and not restarted if an alternative etiology for the signs or symptoms cannot be established.

QT Shortening: XCOPRI can cause shortening of the QT interval. Caution should be used when administering XCOPRI and other drugs that shorten the QT interval as there may be a synergistic effect on the QT interval that would increase the QT shortening risk.

Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including XCOPRI, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Advise patients, their caregivers, and/or families to be alert for these behavioral changes and report them immediately to a healthcare provider.

Neurological Adverse Reactions: XCOPRI causes dose-dependent increases in the neurologic adverse reactions including, dizziness, diplopia, disturbance in gait and coordination, somnolence, and fatigue.

Prescribers should advise patients against engaging in hazardous activities requiring mental alertness, such as operating motor vehicles or dangerous machinery, until the effect of XCOPRI is known.

Withdrawal of AEDs: As with all antiepileptic drugs, XCOPRI should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. But if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered.

MOST COMMON ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical studies, the most common adverse reactions that occurred in XCOPRI-treated patients (incidence at least 10% and greater than placebo) were somnolence, dizziness, fatigue, diplopia, headache.

DOSING CONSIDERATIONS

Dosage adjustment of XCOPRI or other concomitant medications may be necessary.

  • Consider gradually reducing phenytoin dosages by up to 50% during initial titration.
  • Consider reducing dosages of phenobarbital and clobazam as needed when used concomitantly with XCOPRI. When XCOPRI and carbamazepine or lamotrigine are taken concomitantly, consider increasing dosages as needed of carbamazepine or lamotrigine.
  • Consider increasing dosages as needed of drugs which are CYP2B6 and CYP3A substrates and decreasing dosages as needed of drugs which are CYP2C19 substrates.
  • Effectiveness of hormonal oral contraceptives may be reduced when administered concomitantly with XCOPRI. Women should use additional or alternative non-hormonal birth control.

Dosage reduction of XCOPRI may be considered in patients with mild to moderate and severe renal impairment. XCOPRI use is not recommended in end‑stage renal disease.

The maximum recommended daily dose is 200 mg for patients with mild or moderate hepatic impairment. XCOPRI use is not recommended in patients with severe hepatic impairment

DRUG ABUSE

XCOPRI is a Schedule V controlled substance.

INDICATION

XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.

Please see full Prescribing Information.