Cenobamate (YKP3089) is a small molecule approved in the United States (US), Europe and several other countries around the world for the treatment of Partial-Onset (focal) seizures in adult subjects (≥18 years of age). In the US it is approved for use as monotherapy, however, there is little clinical data assessing its use as monotherapy in adults with POS. This study is designed to explore the effectiveness of doses of 100 mg/day and 200 mg/day as monotherapy in adult subjects with newly diagnosed or recurrent POS/focal onset epilepsy.

Start Date18 Jul 2024

Sponsor / Collaborator

SK Life Science, Inc.

NCT06352723 / Not yet recruitingEarly Phase 1IIT

Use of Cenobamate in the Intensive Care Unit for Acute Frequent Seizures and Status Epilepticus

The CENOBITE study will be conducted as a multi-center trial involving X leading centers from the Critical Care EEG Monitoring Consortium (CCEMRC). A total of 10 patients will be recruited over a period of one year, with each patient undergoing monitored treatment regimen. Each site will obtain its own approval from their institutional review board. Data will be shared through the MGB REDCap; raw EEG files will be shared through the MGB Dropbox and analyzed at the BWH.
Monitoring for the development of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, a potential adverse reaction, will be a key aspect of the study. Regular assessments, including RegiSCAR scoring (a validated scoring system for DREeSS5), daily serum cenobamate level measurements, and comprehensive lab tests, will be conducted to ensure patient safety and the effective management of any adverse reactions such as DRESS syndrome.

Start Date01 Apr 2024

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

JPRN-jRCT2031220198 / RecruitingPhase 2

ONO-2017-02:A Phase 2, Multicenter Open-Label Extension Study to Evaluate the Long-term Safety of Cenobamate in Japanese Subjects with Partial Onset Seizures

Start Date04 Nov 2022

Sponsor / Collaborator-

100 Clinical Results associated with Cenobamate

100 Translational Medicine associated with Cenobamate

100 Patents (Medical) associated with Cenobamate

122

Literatures (Medical) associated with Cenobamate

01 Mar 2024·Epilepsy & behavior : E&B

Efficacy and safety of six new antiseizure medications for adjunctive treatment of focal epilepsy and epileptic syndrome: A systematic review and network meta-analysis

Review

Author: Li, Qifu ; Liu, Jiaqi ; Li, Zongjun ; Tong, Jingyi ; Chen, Yibin ; Lu, Na ; Ji, Tingting ; Liu, Ting

OBJECTIVE:

This study aimed to evaluate the efficacy and safety of six new antiseizure medications (ASMs) for adjunctive treatment in adult patients with focal epilepsy and adolescents with Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), or tuberous sclerosis complex (TSC).

METHODS:

A comprehensive literature search was performed using PubMed, Medline, Embase, and Cochrane library databases from inception to October 13, 2023. We included published studies for a systematic review and a network meta-analysis (NMA). The efficacy and safety were reported in terms of a 50% response rate and dropout rate along with serious adverse events (SAEs). The outcomes were ranked with the surface under the cumulative ranking curve (SUCRA).

RESULTS:

Twenty eligible trials with 5516 patients and 21 interventions, including placebo, contributed to the analysis. Included ASMs were brivaracetam (BRV), cenobamate (CBM), cannabidiol (CBD), fenfluramine (FFM), everolimus (ELM), and soticlestat (SLT). The six new ASMs were compared in four different epilepsy subtypes. In focal epilepsy treatment, BRV seemed to be safe [vs placebo, risk ratio (RR) = 0.69, 95 % confidence interval (CI): 0.25-1.91] and effective (vs placebo, RR = 2.18, 95 % CI: 1.25-3.81). In treating focal epilepsy, CBM 300 mg was more effective at a 50 % response rate (SUCRA 91.8 %) compared with BRV and CBD. However, with the increase in dosage, more SAEs (SUCRA 85.6 %) appeared compared with other ASMs. CBD had good efficacy on LGS (SUCRA 88.4) and DS (SUCRA 66.2), but the effect on adult focal epilepsy was not better than that of placebo [vs placebo, RR = 0.83 (0.36-1.93)]. The NMA indicated that the likelihood of the most appropriate intervention (SUCRA 91.2 %) with minimum side effects（SUCRA 12.5 %）for the DS was FFM. Compared with CBD, high exposure to ELM demonstrated a more effective treatment of TSC (SUCRA 89.7 %). More high-quality SLT studies are needed to further evaluate the efficacy and safety. The comparison-adjusted funnel plots of annualized relapse rate and side effects in the included studies revealed no significant funnel plot asymmetry.

CONCLUSIONS:

This NMA indicated that the most effective treatment strategy for focal epilepsy, DS, Lennox-Gastaut syndrome, and TSC, respectively, included CBM 300 mg, FFM, CBD, and ELM. However, the aforementioned findings need further confirmation.

01 Feb 2024·Epilepsy & behavior : E&B

Cognitive and psychiatric adverse events during adjunctive cenobamate treatment in phase 2 and phase 3 clinical studies

Article

Author: Chung, Steve S ; Ferrari, Louis ; Krauss, Gregory L ; Rosenfeld, William E ; Stern, Sean

OBJECTIVE:

Cognitive and psychiatric adverse events in patients with epilepsy are important determinants of therapeutic outcomes and patient quality of life. We assessed the relationship between adjunctive cenobamate treatment and selected cognitive and psychiatric treatment-emergent adverse events (TEAEs) in adults with uncontrolled focal epilepsy.

METHODS:

This was a retrospective analysis of pooled populations of patients with focal epilepsy from two phase 2, randomized, double-blind clinical trials; two open-label extensions (OLEs) of those trials; and a long-term, open-label, phase 3 safety study. Occurrence of cognitive and psychiatric TEAEs in patients treated with adjunctive cenobamate or placebo during double-blind treatment were evaluated. Exposure-adjusted incidence rates of the cognitive and psychiatric TEAEs, defined as the number of TEAEs per patient-year of treatment, during up to 7 years of long-term adjunctive cenobamate treatment, were determined in the pooled OLE and phase 3 patient populations.

RESULTS:

The pooled randomized trials resulted in a population of 442 patients treated with cenobamate (100 mg/day: n = 108; 200 mg/day: n = 223; 400 mg/day: n = 111) and 216 placebo-treated patients. The combined open-label studies resulted in pooled populations of cenobamate-treated patients ranging from n = 1690 during Year 1 to n = 103 during Year 7. Among cenobamate-treated (all doses) and placebo-treated patients during double-blind treatment, cognitive TEAEs were reported by ≤ 1.9 % (range, 0 %-1.9 %) and ≤ 0.5 % (range, 0 %-0.5 %), respectively, and psychiatric TEAEs by ≤ 3.6 % (range, 0 %-3.6 %) and ≤ 3.2 % (range, 0 %-3.2 %), respectively. During up to 7 years of open-label adjunctive cenobamate treatment, exposure-adjusted incidence rates of cognitive and psychiatric TEAEs were < 0.018 and < 0.038 events per patient-year, respectively. Discontinuation of adjunctive cenobamate due to cognitive or psychiatric TEAEs assessed in this study during double-blind or open-label treatment occurred in ≤ 0.3 % and ≤ 1.7 % of patients, respectively.

CONCLUSIONS:

Cognitive and psychiatric TEAEs were reported by similar numbers of cenobamate- and placebo-treated patients during double-blind adjunctive cenobamate treatment (< 4 % of patients), and exposure-adjusted incidence rates of these TEAEs remained low during open-label cenobamate treatment for up to 7 years. Treatment discontinuations due to these TEAEs were rare. The results of this post-hoc analysis indicate that adjunctive cenobamate treatment exhibits a low incidence of cognitive or psychiatric TEAEs in patients with uncontrolled focal seizures.

01 Jan 2024·European journal of pharmacology

Cenobamate enhances the anticonvulsant effect of other antiseizure medications in the DBA/2 mouse model of reflex epilepsy

Article

Author: Leo, Antonio ; Gallelli, Luca ; Bosco, Francesca ; Citraro, Rita ; Guarnieri, Lorenza ; Rania, Vincenzo ; De Sarro, Giovambattista ; De Sarro, Caterina

Clinical studies documented that cenobamate (CNB) has a marked efficacy compared to other antiseizure medications (ASMs) in reducing focal seizures. To date, different aspects of CNB need to be clarified, including its efficacy against generalized seizures. Similarly, the pattern of drug-drug interactions between CNB and other ASMs also compels further investigation. This study aimed to detect the role of CNB on generalized seizures using the DBA/2 mouse model. We have also studied the effects of an adjunctive CNB treatment on the antiseizure properties of some ASMs against reflex seizures. The effects of this adjunctive treatment on motor performance, body temperature, and brain levels of ASMs were also evaluated. ^CNB was able to antagonize seizures in DBA/2 mice. CNB, at 5 mg/kg, enhanced the antiseizure activity of ASMs, such as diazepam, clobazam, levetiracetam, perampanel, phenobarbital, topiramate, and valproate. No synergistic effects were observed when CNB was co-administered with some Na⁺ channel blockers. The increase in antiseizure activity was associated with a comparable intensification in motor impairment; however, the therapeutic index of combined treatment of ASMs with CNB was more favorable than the combination with vehicle except for carbamazepine, phenytoin, and oxcarbazepine. Since CNB did not significantly influence the brain levels of the ASMs studied, we suggest that pharmacokinetic interactions seem not probable. Overall, this study shows the ability of CNB to counteract generalized reflex seizures in mice. Moreover, our data documented an evident synergistic antiseizure effect for the combination of CNB with ASMs including phenobarbital, benzodiazepines, valproate, perampanel, topiramate, and levetiracetam.

News (Medical) associated with Cenobamate

12 Apr 2024

·www.pharmaceutical-technology.com

FDA approves new administration routes for Xcopri

Partial-onset seizure epilepsy is where seizures originate in one area of the brain, causing symptoms such as muscle jerking and altered consciousness. Credit: peterschreiber.media via Shutterstock. South Korea-based SK Life Sciences has received US Food and Drug Administration (FDA) approval for two new forms of administration of its epilepsy drug Xcopri (cenobamate), as an oral suspension mixed with water for mouth administration or via a nasogastric tube. Discovered and developed by SK Biopharmaceuticals, Xcopri is an anti-epileptic drug indicated for partial-onset seizures in adults. The therapy reduces repetitive neuronal firing by inhibiting voltage-gated sodium currents, leading to a decreased occurrence of seizures. The oral form of the treatment is taken once daily. The FDA-approved label revision is based on findings from an open-label study comparing the bioequivalence of three ways of administering the medication: swallowing a whole tablet, taking a crushed tablet in water by mouth, and using a nasogastric tube to administer a crushed tablet in water. The approval addresses the needs of patients living with epilepsy, who are unable to swallow Xcopri tablets whole, says Louis Ferrari, SK Life Sciences vice president of medical affairs. “In some patients, crushing tablets offer an additional option for dosing and administration by nasogastric tube. This label update addresses an unmet need for this patient population and offers administration alternatives to the healthcare providers managing their care,” says Ferrari. See Also: Candel wins FDA orphan drug designation for pancreatic cancer drug FDA approves AstraZeneca’s FASENRA for asthma in children Xcopri was first approved by the FDA in November 2019 for partial-onset seizures in adults, followed by a European approval of the drug in 2021 under the name Ontozry. The treatment is commercialised by Angelini Pharma, following the acquisition of Arvelle Therapeutics, who signed an exclusive licensing agreement with SK Biopharmaceuticals worth $430m in February 2019. Angelini acquired Arvelle in a $960m deal in 2021. According to GlobalData’s Pharma Intelligence Center, Xcopri/Ontozry is forecast to generate $1.5bn in sales in 2027. GlobalData is the parent company of Pharmaceutical Technology. Partial-onset seizure epilepsy is a type of epilepsy where seizures originate in one area of the brain. Seizures can cause a variety of symptoms depending on the part of the brain affected such as muscle jerking, sensory disturbances, or altered consciousness.

Drug ApprovalOrphan DrugAcquisitionLicense out/in

11 Apr 2024

·www.prnewswire.com

XCOPRI® (cenobamate tablets) CV Receives FDA Approval for Alternate Methods of Administration That Include Crushed Tablet in Liquid Suspension Taken Orally or Through a Nasogastric Tube

PARAMUS, N.J., April 11, 2024 /PRNewswire/ -- SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals, Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) approved two new administration options of XCOPRI® (cenobamate tablets) CV, an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, which can now be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. "The approval addresses the needs of patients living with epilepsy who are currently taking, or who may benefit from starting XCOPRI, but are unable to swallow the tablets whole," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science. "In some patients, crushing tablets offers an additional option for dosing and administration by nasogastric tube. This label update addresses an unmet need for this patient population and offers administration alternatives to the healthcare providers managing their care." The FDA-approved label update considered the results of an open-label, randomized, single-center, 3-period, 6-sequence, balanced crossover study demonstrating bioequivalence between three administration routes including swallowing an intact tablet, as a crushed tablet suspended in water and taken orally, and as a crushed tablet suspended in water and administered via a nasogastric tube. About Epilepsy Epilepsy is the fourth most common neurological disorder. There are approximately 3.4 million people living with epilepsy in the United States, with 150,000 new cases each year in the country.1,2 Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one's safety, relationships, work, driving, and much more.3,4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).3,4 Despite the availability of many antiepileptic therapies, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.5 About XCOPRI® (cenobamate tablets) CV  Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.   Cenobamate is approved in the United States for the treatment of partial-onset seizures in adults and is available under the brand name XCOPRI® (cenobamate tablets) CV. Cenobamate can be combined with other ASMs or used alone. The recommended initial dosage of cenobamate is 12.5 mg once-daily, with titration every two weeks; it is available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg. Cenobamate is also approved in the European Union and the United Kingdom for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizures that have not been adequately controlled despite a history of treatment with at least two antiepileptic medicinal products and is marketed by Angelini Pharma under the brand name ONTOZRY®. Additionally, cenobamate is in clinical development in Asia. Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercialize cenobamate in Japan and in the Greater China region, respectively. SK Biopharmaceuticals has recently entered into an exclusive licensing agreement with Endo for cenobamate in Canada. IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV DO NOT TAKE XCOPRI IF YOU: Are allergic to cenobamate or any of the other ingredients in XCOPRI. Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart. XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING: Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider. QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood. Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you. Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider. DISCONTINUATION: Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). DRUG INTERACTIONS: XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. PREGNANCY AND LACTATION: XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to . Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI. COMMON SIDE EFFECTS: The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired. These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at . DRUG ABUSE: XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law. INDICATION: XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age. Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Please see full Prescribing Information. About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc. SK Biopharmaceuticals and its U.S. subsidiary SK Life Science are pharmaceutical companies focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin their expansion into oncology through research and development efforts. The companies have a pipeline of eight compounds in development in both CNS disorders and oncology. Additionally, SK Biopharmaceuticals is focused on the discovery of new treatments in oncology. For more information, visit SK Biopharmaceuticals' website at and SK Life Science's website at . Both SK Biopharmaceuticals and SK Life Science are part of SK Group, one of the largest conglomerates in Korea. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information, please visit . XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. References Epilepsy Foundation. Who Can Get Epilepsy? . Accessed April 2024. Epilepsy Foundation. Facts & Statistics About Epilepsy. . Accessed April 2024. Epilepsy Foundation. Staying Safe. . Accessed April 2024. Epilepsy Foundation. Complications and Risks. . Accessed April 2024. Chen Z, Brodie MJ, Liew D, Kwan P. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs: a 30-year longitudinal cohort study. . Published online December 26, 2017. SOURCE SK Life Science, Inc.

Drug ApprovalLicense out/in

09 Apr 2024

·www.prnewswire.com

SK Life Science Announces Data Presentations for XCOPRI® (cenobamate tablets) CV at the 2024 American Academy of Neurology Annual Meeting

PARAMUS, N.J., April 9, 2024 /PRNewswire/ -- SK Life Science, Inc., a U.S. pharmaceutical company in pursuit of developing treatments that will change the future of central nervous system (CNS) disorders, today announced the schedule for two oral and six poster presentations at the American Academy of Neurology (AAN) Annual Meeting taking place April 13–18, 2024, virtually and in-person in Denver, Colorado. The data includes a study examining the relative bioavailability of cenobamate as an intact or crushed tablet administered either orally or via nasogastric tube, and a retrospective claims-based analysis comparing the effectiveness of cenobamate in reducing hospitalizations among patients with focal-onset seizures. "We are looking forward to sharing data on the use and administration of XCOPRI in adults with partial-onset (focal) seizures at this year's AAN meeting," said Louis Ferrari, RPh, MBA, vice president, Medical Affairs. "At SK Life Science we are continually conducting research that will help healthcare professionals and equip them with the information they need to care for patients living with the challenges of epilepsy. We continue to do this via ongoing research, relevant post-hoc analyses, and the publication of real-world data on the use of cenobamate in the U.S. and globally." Abstracts are available online on the AAN meeting website here and on site at booth #1262. The schedule of oral and poster presentations is detailed below. Oral Presentations Title: Comparative Effectiveness of Cenobamate in Reducing Hospitalizations in Patients with Focal-Onset Seizures: A Retrospective Claims-Based Analysis (Urban et al) Session: S29: Epilepsy Diagnostics and Therapeutics Date: Wednesday, April 17 Time: 1:24 PM Title: Relative Bioavailability of Cenobamate 200 mg Administered as a Crushed Tablet, Either Orally or via Nasogastric Tube, vs an Intact 200-mg Cenobamate Tablet (Vashi et al) Session: S29: Epilepsy Diagnostics and Therapeutics Date: Wednesday, April 17 Time: 1:36 PM Poster Presentations Title: Effectiveness Of Cenobamate in Pediatric Patients with Lennox-Gastaut Syndrome: A Retrospective Claims-based Analysis (Keough et al) Session: P1: Epilepsy/Clinical Neurophysiology (EEG): Pediatric Epilepsy 1 Date: Sunday, April 14 Time: 8:00 – 9:00 AM Title: Effectiveness Of Cenobamate in Pediatric Patients with Intractable Focal Seizures: A Retrospective Claims-based Analysis (Labiner et al) Session: P2: Epilepsy/Clinical Neurophysiology (EEG): Pediatric Epilepsy 2 Date: Sunday, April 14 Time: 11:45 AM – 12:45 PM Title: Increased Incidence of Comorbidities in Patients with Uncontrolled Epilepsy (Faught et al) Session: P4: Epilepsy/Clinical Neurophysiology (EEG): Epilepsy Co-morbidities and Special Populations Date: Monday, April 15 Time: 11:45 AM – 12:45 PM Title: Effectiveness Of Cenobamate in Postsurgical Patients: A Retrospective Claims-based Analysis (Pellinen et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes Date: Tuesday: April 16 Time: 5:30 – 6:30 PM Title: Cenobamate Use as Monotherapy: A Retrospective Claims-based Analysis (Becker et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes Date: Tuesday, April 16 Time: 5:30 – 6:30 PM Title: Dose Reduction Timing for Concomitant Antiseizure Medications: Post-hoc Analysis of a Phase 3, Open-label Study Of Cenobamate For Treatment Of Uncontrolled Focal Seizures (Ferrari et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical Trials and Outcomes Date: Tuesday, April 16 Time: 5:30 – 6:30 PM About XCOPRI® (cenobamate tablets) CV  Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. While the precise mechanism by which cenobamate exerts its therapeutic effect is unknown, it is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel.   Cenobamate is approved in the United States for the treatment of partial-onset seizures in adults and is available under the brand name XCOPRI® (cenobamate tablets) CV. Cenobamate can be combined with other ASMs or used alone. The recommended initial dosage of cenobamate is 12.5 mg once-daily, with titration every two weeks; it is available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg. Cenobamate is also approved in the European Union and the United Kingdom for the adjunctive treatment of focal-onset (partial-onset) seizures with or without secondary generalization in adult patients with seizures that have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products and is marketed by Angelini Pharma under the brand name ONTOZRY®. Additionally, cenobamate is in clinical development in Asia. Ono Pharmaceutical and Ignis Therapeutics have the rights to develop and commercialize cenobamate in Japan and in the Greater China region, respectively. SK Biopharmaceuticals has recently entered into an exclusive licensing agreement with Endo for cenobamate in Canada. IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI® (cenobamate tablets) CV DO NOT TAKE XCOPRI IF YOU: Are allergic to cenobamate or any of the other ingredients in XCOPRI. Have a genetic problem (called Familial Short QT syndrome) that affects the electrical system of the heart. XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING: Allergic reactions: XCOPRI can cause serious skin rash or other serious allergic reactions which may affect organs and other parts of your body like the liver or blood cells. You may or may not have a rash with these types of reactions. Call your healthcare provider right away and go to the nearest emergency room if you have any of the following: swelling of your face, eyes, lips, or tongue, trouble swallowing or breathing, a skin rash, hives, fever, swollen glands, or sore throat that does not go away or comes and goes, painful sores in the mouth or around your eyes, yellowing of your skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain, frequent infections, or infections that do not go away. Take XCOPRI exactly as your healthcare provider tells you to take it. It is very important to increase your dose of XCOPRI slowly, as instructed by your healthcare provider. QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood. Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you. Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider. DISCONTINUATION: Do not stop taking XCOPRI without first talking to your healthcare provider. Stopping XCOPRI suddenly can cause serious problems. Stopping seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). DRUG INTERACTIONS: XCOPRI may affect the way other medicines work, and other medicines may affect how XCOPRI works. Do not start or stop other medicines without talking to your healthcare provider. Tell healthcare providers about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. PREGNANCY AND LACTATION: XCOPRI may cause your birth control medicine to be less effective. Talk to your health care provider about the best birth control method to use. Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to . Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI. COMMON SIDE EFFECTS: The most common side effects in patients taking XCOPRI include dizziness, sleepiness, headache, double vision, and feeling tired. These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at . DRUG ABUSE: XCOPRI is a federally controlled substance (CV) because it can be abused or lead to dependence. Keep XCOPRI in a safe place to prevent misuse and abuse. Selling or giving away XCOPRI may harm others and is against the law. INDICATION: XCOPRI is a prescription medicine used to treat partial-onset seizures in adults 18 years of age and older. It is not known if XCOPRI is safe and effective in children under 18 years of age. Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. Please see full Prescribing Information. About Epilepsy Epilepsy is the fourth most common neurological disorder. Approximately 3.4 million people are living with epilepsy in the United States, with 150,000 new cases each year in the country.1,2 Epilepsy is characterized by recurrent, unprovoked seizures. The seizures in epilepsy may be related to a brain injury or a family tendency, but often the cause is completely unknown. Having seizures and epilepsy can affect one's safety, relationships, work, driving, and much more.3,4 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).3,4 Despite the availability of many antiepileptic therapies, almost 40 percent of people with epilepsy are not able to achieve seizure freedom, meaning they have epilepsy that remains uncontrolled.5 About SK Biopharmaceuticals Co., Ltd. and SK Life Science, Inc. SK Biopharmaceuticals and its U.S. subsidiary SK Life Science are pharmaceutical companies focused on the research, development, and commercialization of treatments for disorders of the central nervous system (CNS) and oncology. In 2017, SK Biopharmaceuticals established a research center to begin its expansion into oncology through research and development efforts. The companies have a pipeline of eight compounds in development in both CNS disorders and oncology. Additionally, SK Biopharmaceuticals is focused on the discovery of new treatments in oncology. For more information, visit SK Biopharmaceuticals' website at and SK Life Science's website at . Both SK Biopharmaceuticals and SK Life Science are part of SK Group, one of the largest conglomerates in Korea. SK Inc., the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Inc. is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. References Epilepsy Foundation. Who Can Get Epilepsy? . Accessed April 2024. Epilepsy Foundation. Facts & Statistics About Epilepsy. . Accessed April 2024. Epilepsy Foundation. Staying Safe. . Accessed April 2024. Epilepsy Foundation. Complications and Risks. . Accessed April 2024. Chen Z, Brodie MJ, Liew D, Kwan P. Treatment outcomes in patients with newly diagnosed epilepsy treated with established and new antiepileptic drugs: a 30-year longitudinal cohort study. . Published online December 26, 2017. SOURCE SK Life Science, Inc.

Drug ApprovalLicense out/inPhase 3

100 Deals associated with Cenobamate

External Link

KEGG	Wiki	ATC	Drug Bank
D11150	-	N03A	DB06119

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	EU	Angelini Pharma, Inc.	26 Mar 2021
Epilepsy	IS	Angelini Pharma, Inc.	26 Mar 2021
Epilepsy	LI	Angelini Pharma, Inc.	26 Mar 2021
Epilepsy	NO	Angelini Pharma, Inc.	26 Mar 2021
Seizures	EU	Angelini Pharma, Inc.	26 Mar 2021
Seizures	IS	Angelini Pharma, Inc.	26 Mar 2021
Seizures	LI	Angelini Pharma, Inc.	26 Mar 2021
Seizures	NO	Angelini Pharma, Inc.	26 Mar 2021
Epilepsies, Partial	US	SK Life Science, Inc.	21 Nov 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Seropositivity	Phase 3	CN	SK Life Science, Inc.	08 Mar 2021
HIV Seropositivity	Phase 3	JP	SK Life Science, Inc.	08 Mar 2021
HIV Seropositivity	Phase 3	KR	SK Life Science, Inc.	08 Mar 2021
Epilepsy, Tonic-Clonic	Phase 3	US	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	BG	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	CZ	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	HU	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	PL	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	SK	SK Life Science, Inc.	13 Aug 2019
Epilepsy, Tonic-Clonic	Phase 3	UA	SK Life Science, Inc.	13 Aug 2019

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ANA2023	Phase 2	-	54	Cenobamate	vyivvwzpvv(sosbblzxfs) = tonwiakjzh vxcetfnkxx (ppgfdqphtj ) View more	Positive	01 Sep 2023
P12-1.012 (AAN2023)	Phase 2/3	Sudden Unexpected Death in Epilepsy	2,131	Cenobamate	womlwygemw(zctcctucsi) = pqjyfhcmuk uupxezonrf (ooytfsppur ) View more	Positive	25 Apr 2023
S44.006 (AAN2023)	Phase 3	-	214	Cenobamate	uqtljsacgp(plgeqkjssw) = dbdcqadtuv yyjzhlsesf (usiaivoosu ) View more	-	25 Apr 2023
P4-1.005 (AAN2023)	Not Applicable	-	-	Cenobamate	iaopqvwbet(zegwkfqgko) = pzqewuhozy nzcbdyyaqr (vrdaegkuik )	Positive	25 Apr 2023
P4-1.005 (AAN2023)	Not Applicable	-	-	Branded ASMs	iaopqvwbet(zegwkfqgko) = yoghfqhvbw nzcbdyyaqr (vrdaegkuik )	Positive	25 Apr 2023
P4-1.002 (AAN2023)	Phase 3	Seizures	1,340	Cenobamate	grjgxyfowp(cwyovfjkly) = lhbesycood wfdvgsogrp (crneguwhjj )	Positive	25 Apr 2023
AAN2023	Phase 3	-	214	Cenobamate	nzfllysjyb(bvgvvdnsah) = dnjvyzxiay qsoeucutna (gedkfvsfbt ) View more	Positive	25 Apr 2023
NCT01866111 (Pubmed) Manual	Phase 2	Seizures Adjuvant	355	Cenobamate	bgqeguzsic(kkihmybmlw) = nqnjifrxlt cixtaauxjc (mnorgvqgec ) View more	Positive	15 Jun 2022
AAN2022	Not Applicable	Epilepsies, Partial	-	Adjunctive Cenobamate	dyjvvunqej(ltzfrrngzk) = n=1; resolved with lowered clobazam fjoxywwixl (iqftfazzoi ) View more	Positive	03 May 2022
AAN2022	Phase 3	Epilepsies, Partial	240	Cenobamate	bxjfyvdxzx(invjvxncrd) = kemaxcodom dwocceexew (ntyqnvegid )	-	03 May 2022
P13-8.005 (AAN2022)	Phase 2/3	-	-	Cenobamate	xcoeijzvhz(grjzaaleuk) = ioolgjtdsk dknuzhmmcw (srxfxaybsj ) View more	Positive	03 May 2022
P13-8.005 (AAN2022)	Phase 2/3	-	-	Placebo	dumcfxzgki(eivvzzyilj) = oxvshnnyoq cmobwmffpv (aqfutzvaqp )	Positive	03 May 2022

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