Observational Cohort Study on Adult Patients with Not-adequately Controlled FOcal-onset Seizures Treated with Cenobamate As Early AdjUnctive Therapy in a Real-world Setting - FOCUS

Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

Start Date01 Dec 2024

Sponsor / Collaborator

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. - SpA

[+1]

NCT06453213

/ RecruitingPhase 4

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

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 Date14 Oct 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.

100 Clinical Results associated with Cenobamate

100 Translational Medicine associated with Cenobamate

100 Patents (Medical) associated with Cenobamate

193

Literatures (Medical) associated with Cenobamate

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact analysis of cenobamate for epilepsy patients with drug-resistant focal onset seizures in the Netherlands

Article

Author: Rijkers, Kim ; Gubler, Felix ; Hiligsmann, Mickaël ; Evers, Silvia ; Laskier-Owens, Vicki ; Klarenbeek, Pim ; Li, Nannan ; Rouhl, Rob ; Majoie, Marian ; Lazeron, Richard

OBJECTIVE:

The objective of this study was to explore the financial consequences of adopting cenobamate as a treatment alternative in epilepsy patients with drug-resistant focal onset seizures (FOS) from a societal perspective in the Netherlands.

METHODS:

A previous budget impact model with a 5-year time horizon was adapted to the Dutch setting accounting for the eligible population, real-world market shares, treatment effectiveness and resource use in two scenarios: cenobamate with constant market share versus cenobamate with linearly increased market share up to 20%. Clinical inputs included treatment response, seizure reduction and adverse events. Costs consisted of drugs, medical and non-medical costs. One-way sensitivity analysis and scenario analysis were conducted to test the robustness of our results.

RESULTS:

14,723 patients were eligible for cenobamate in 2022. Although cenobamate adds a gross budget impact of €12,686,30, the displacement of other drugs yields a total impact on the drug budget of €3,722,596 over 5 years. Adopting cenobamate resulted in a medical cost savings of €13,499,498 due to less resource use, and non-medical cost savings of €22,144,054 due to reduced productivity losses. Overall, savings generated at medical and non-medical cost level offset the gross drug budget impact of cenobamate, resulting in a saving of €31,920,955 over 5 years. Results were robust in the sensitivity/scenario analyses.

CONCLUSION:

Treatment with cenobamate is associated with both medical and non-medical cost savings, which offset the increase in drug budget and result in a significant potential budget saving. The higher the market share of cenobamate, the larger the budget savings. We acknowledge several limitations; Complex scenarios such as drug interactions, stopping/switching drugs, and multiple drug use were not taken into account. The long-term efficacy and safety of cenobamate and its comparators remains uncertain. Future real-world data are needed to confirm our findings.

01 Feb 2025·TOXICOLOGY AND APPLIED PHARMACOLOGY

Neurotoxicity study of cenobamate-induced zebrafish early developmental stages

Article

Author: Liu, Jiahao ; Zeng, Pei ; Liu, Yao ; Wang, Luchuan ; Guo, Jin ; Fan, Yanping ; Li, Yue ; Fang, Liya ; Liu, Yuanyuan ; Li, Jiawei ; Gong, Chao

Cenobamate (CNB) is a novel anti-seizure medication with significant efficacy in treating epilepsy. However, in clinical trials, the most common adverse reactions observed in patients are central nervous system (CNS) symptoms. In animal studies, administration of CNB during pregnancy or lactation has been associated with adverse effects on neurodevelopment in offspring. To optimize the clinical use of CNB, we investigated the neurotoxicity of different concentrations of CNB (10, 20, 40, 80, and 160 μM) on zebrafish embryos. Following exposure, zebrafish embryos exhibited abnormal phenotypes such as shortened body length, impaired yolk sac absorption, and decreased heart rate. Behavioral experiments showed that CNB caused abnormal movements such as decreased spontaneous tail curling frequency, shortened total movement distance, and reduced average movement speed. We also found that CNB leads to increased acetylcholinesterase (AChE) activity levels in zebrafish embryos, along with differential expression of neurodevelopment-related genes such as nestin, gfap, synapsin IIa, and gap43. In summary, our research findings indicated that CNB may induce developmental and neurotoxic effects in zebrafish embryos by altering neurotransmitter systems and the expression of neurodevelopmental genes, thereby influencing behavior. This study will provide information for the clinical use of CNB, aiming to benefit more epilepsy patients through its appropriate administration.

01 Feb 2025·SEIZURE-EUROPEAN JOURNAL OF EPILEPSY

Impact of lifetime antiepileptic drug history on cenobamate efficacy in adults with focal epilepsy

Article

Author: Schulze-Bonhage, Andreas ; Hirsch, Martin ; Novitskaya, Yulia ; Martinez-Lizana, Eva ; Brandt, Armin

PURPOSE:

To evaluate the efficacy of cenobamate (CNB) in adults with focal epilepsy based on the number of previous lifetime antiseizure medications (ASMs).

METHODS:

Twenty patients receiving add-on treatment with CNB with <6 lifetime ASMs were retrospectively compared to 20 Patients with >10 ASMs and approximately the same age. Efficacy was assessed at 3, 6, and 12 months following CNB initiation.

RESULTS:

In patients with <6 lifetime ASMs, seizure frequency significantly decreased at 3, 6, and 12 months (p = 0.03, 0.027, 0.048, respectively), while no significant changes were observed in the >10 lifetime ASM group. The median percentage of seizure reduction in the <6 lifetime ASMs group was 58 % at 3 months, 50 % at 6 months, and 92 % at 12 months, compared to 36 %, 50 %, and 42 % in the >10 lifetime ASM group. The seizure-free rate was significantly higher in the <6 lifetime ASMs group at all-time points (p < 0.01), despite a lower median daily dose of CNB in this group. There was a trend toward higher responder rates at 12 months in the <6 lifetime ASMs group, again despite the lower median daily dose of CNB.

CONCLUSIONS:

This study highlights greater efficacy of CNB in patients with <6 lifetime ASMs, showing a significantly higher seizure-free rate and greater seizure reduction compared to those with >10 lifetime ASMs. Despite lower overall response in the latter group, CNB treatment still provided meaningful benefits in highly drug-resistant epilepsy.

News (Medical) associated with Cenobamate

17 Dec 2024

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SK Biopharmaceuticals Inks Research Collaboration Agreement with ProEn Therapeutics Further Accelerating Expansion of Oncology Research and Pipeline for Global Competitiveness in Radiopharmaceuticals

SK Biopharmaceuticals, ProEn Therapeutics aim to advance up to 2 preclinical radiopharmaceutical candidates by 2027, via ArtBody™, a bivalent binder platform designed to selectively target tumor cells SK Biopharmaceuticals eyes innovative small protein-based radiopharmaceuticals on safety and efficacy amid growing global demand through the joint research initiative building on the momentum for its radiopharmaceutical therapy business SEOUL, South Korea, Dec. 16, 2024 /PRNewswire/ -- SK Biopharmaceuticals, a biotech company focusing on the research, development and commercialization of treatments for disorders of the central nervous system and oncology worldwide, announced a research collaboration agreement with ProEn Therapeutics, a biotech company dedicated to advancing oncology treatments, to further extend its oncology research capability and expand its pipeline of radiopharmaceutical therapies (RPT). Under this agreement, both sides seek to advance up to two preclinical candidates for the development of novel radiopharmaceutical drugs by 2027 – the year when SK Biopharmaceuticals aims to become a global leading RPT player, via strengthened internal and external resources. This joint research builds on a series of SK Biopharmaceuticals' global strategic partnerships, including the in-licensing of a radiopharmaceutical compound, and a supply agreement to secure actinium-225, an alpha-particle emitting radioisotope, since the company unveiled its "RPT Roadmap" to gain a competitive edge in the rapidly growing field of nuclear medicine. SK Biopharmaceuticals will leverage ProEn Therapeutics' ArtBody™ platform, a dual-target binding technology that incorporates small proteins[1] to identify and target specific tumor antigens – enhancing tumor selectivity – for the development of potential cancer treatments, while minimizing damage to healthy tissues. ArtBody™, which has intrinsic advantages of high stability and structural robustness, can be mass-produced using bacteria, making it ideal for industrial applications. Il-Han Lee, Chief Executive Officer of ProEn Therapeutics, said, "We are pleased to enter this joint research, and positive that the ArtBody™ platform will generate synergy with and complement SK Biopharmaceuticals' radiopharmaceutical therapy business. ProEn Therapeutics will push to produce the best possible outcome that can meet not only the two companies' expectations, but also patients' needs." Donghoon Lee, Chief Executive Officer of SK Biopharmaceuticals, said, "This collaboration with ProEn Therapeutics is significant as the platform technology will help overcome the limitations of existing therapies. We will aim to develop more effective, safer treatments, while leading global RPT research and development efforts." About SK Biopharmaceuticals SK Biopharmaceuticals focuses 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. SK Biopharmaceuticals is the first and only Korean company to independently develop and commercialize an antiseizure medication, cenobamate (brand name: XCOPRI®), in the U.S. Cenobamate, which was commercially launched in the U.S. in 2020 by SK Biopharmaceuticals and its U.S. subsidiary SK Life Science, has successfully entered five major regions: North America, Europe, Asia, Central and South America, and the Middle East and North Africa. The company has a pipeline of eight compounds in development in both CNS disorders and oncology. For more information, visit SK Biopharmaceuticals' website at , and SK Life Science's website at . About ProEn Therapeutics ProEn Therapeutics is a biotechnology company dedicated to advancing oncology treatments through cutting-edge protein engineering. The company's innovative drug development platform, ArtBody™, focuses on bi-specific antibody-drug conjugates tailored for solid cancers. ProEn Therapeutics is also exploring next-generation therapies such as immune cell engagers and chimeric antigen receptor platforms, while extending its research in radiopharmaceuticals. The company is advancing its proprietary pipeline, while actively collaborating with partners specializing in various therapeutic modalities. For more information, visit ProEn Therapeutics' website at . SOURCE SK Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/in

08 Dec 2024

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SK Life Science, Inc. Presents XCOPRI® (cenobamate tablets) CV Data at the AES 2024 Annual Meeting Showing a Deeper Understanding of Cenobamate's Dual Mechanism of Action

PARAMUS, N.J., Dec. 8, 2024 /PRNewswire/ -- SK Life Science, Inc., a global leader in treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., presented data at the American Epilepsy Society (AES) Annual Meeting, showcasing its antiseizure medication XCOPRI® (cenobamate tablets) CV. Key data offered a better understanding of cenobamate's unique dual mechanism of action (MOA) that enhances GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel and reduces neuronal excitability by preferentially inhibiting the persistent sodium current. Continue Reading "We are a company dedicated to advancing treatment options for epilepsy, supporting the epilepsy community and providing meaningful solutions for patients and their families," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science. "It is critically important for patients with epilepsy to achieve seizure control as early as possible. The data we presented at AES offer new insights into our drug's unique dual MOA and highlight the potential for flexible and individualized dosing with cenobamate which, along with adjustment of concomitant ASMs to improve tolerability, may help more patients achieve optimal seizure reduction. Additionally, our data provided objective evidence of our treatment's effect on patterns of electrical activity in the brain and seizure reduction." We are dedicated to advancing treatment options and providing meaningful solutions for the epilepsy community. Post this Clarification of the MOA of cenobamate Deeper understanding of cenobamate's bi-modal mechanism of action further elucidates its dual role on voltage-gated sodium channels and GABAA receptors. Specifically, in preclinical studies, researchers observed cenobamate's selectivity for blockade of persistent sodium currents (INaP), while sparing the transient sodium current (INaT). The effect of cenobamate's selective INaP block on the resting membrane potential is augmented by its positive allosteric modulation of GABAA receptor-mediated tonic currents. Cenobamate's selectivity for the INaP over the INaT likely represents action on the NaV1.6 channel over the NaV1.1 channel, a feature not seen with traditional ASMs, like phenytoin or carbamazepine. Potential for flexible and individualized dosing New data examining the initial doses of cenobamate that were associated with seizure freedom in the phase 3 open-label efficacy subset showed the initial seizure freedom interval occurred at a wide range of cenobamate doses, with some patients requiring higher doses. These data highlight the potential for flexible and individualized dosing with cenobamate which, along with adjustment of concomitant antiseizure medication to improve tolerability, may help more patients achieve optimal seizure reduction. The effect of cenobamate on responsive neurostimulation epileptiform events A retrospective, multicenter, observational, 24-week study among 37 patients with uncontrolled seizures, showed a significant reduction in epileptiform events along with a significant reduction in clinically reported seizures during adjunctive cenobamate treatment. Results from this analysis demonstrate, through electrocorticographic data and observation of clinical seizures, the effectiveness of cenobamate in the treatment of focal seizures. The complete list of SK Life Science abstracts presented at AES can be found here. About SK Life Science, Inc. and SK Biopharmaceuticals Co., Ltd. SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with eight compounds currently in development. SK Life Science and SK Biopharmaceuticals are committed to addressing critical unmet medical needs for patients with conditions such as epilepsy, sleep disorders, neuropathic pain, Alzheimer's disease, and schizophrenia. For more information, visit . SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea's second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals and digital business. For more information about SK Biopharmaceuticals, visit . About XCOPRI® (cenobamate tablets) CV Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium current and enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel. The precise mechanism by which Cenobamate exerts its therapeutic effect is unknown. Cenobamate is marketed under the brand name XCOPRI® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals' partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland. Cenobamate is also being developed for commercialization by SK Biopharmaceuticals' partners in many other countries to meet the needs of patients living with epilepsy, including Dong-A ST Co., Ltd., Eurofarma Laboratórios S.A., Hikma MENA FZE, Ignis Therapeutics, Inc. and ONO Pharmaceutical Co., Ltd. XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. 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. 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 References Epilepsy Foundation. Who Can Get Epilepsy? . Accessed December 2024. Epilepsy Foundation. Facts & Statistics About Epilepsy. . Accessed December 2024. Epilepsy Foundation. Staying Safe. . Accessed December 2024. Epilepsy Foundation. Complications and Risks. . Accessed December 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 3

25 Nov 2024

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SK Life Science Presents Cenobamate Research at the 2024 American Epilepsy Society (AES) Annual Meeting

SK Life Science will also host the "Prioritizing Seizure Treatments Through Real-World Patient Case Studies Symposium," an expert led panel to advance the discussion regarding the unmet need for achieving seizure freedom and the impact of continued seizures on patients' treatment journeys PARAMUS, N.J., Nov. 25, 2024 /PRNewswire/ -- SK Life Science, Inc., a global leader in treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., will present updated data on cenobamate, an anti-seizure medication, at the 2024 American Epilepsy Society (AES) Annual Meeting in Los Angeles, California, December 6-10, 2024. The company will also host the "Prioritizing Seizure Treatments Through Real-World Patient Case Studies Symposium," an event led by world-renowned epileptologists. Continue Reading "The pursuit of seizure freedom is a critical and often elusive goal for epilepsy patients," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science. "Our data presentations this year aim to provide healthcare providers with updated strategies and evidence to better address the needs of their patients. Our research will contribute information that highlights cenobamate's potential as a treatment option covering diverse aspects of cenobamate's efficacy, safety, and mechanism of action." SK Life Science's Symposium will focus on real-world patient case studies in seizure treatment. Post this SK Life Science's Symposium will focus on real-world patient case studies in seizure treatment and will take place on Friday, December 6, 2024, at 6:00 p.m. PT in the Platinum Ballroom A-C at the JW Marriott Los Angeles L.A. LIVE during the AES Annual Meeting. This session will highlight three key objectives: Understanding the unmet need for achieving seizure freedom and identifying patients requiring treatment modifications Recognizing the impact of continued seizures on patients' treatment journeys Optimizing treatment regimens for early efficacy, improving the likelihood of seizure freedom, and reducing concomitant medications The session will feature David Vossler, MD, FAAN, FAES, FACNS, Clinical Professor of Neurology, University of Washington; Danielle Becker, MD, MS, FAES, Division Director of Epilepsy, The Ohio State University Wexner Medical Center; and, Mohammad Koubeissi, MD, FAAN, FANA, FAES, Director, GW Epilepsy Center, The George Washington University. Interested participants attending AES can pre-register at . Poster Presentations I. Poster Session 1: Saturday, Dec. 7; author presentations from 12 PM – 2 PM Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Cenobamate in Asian Patients With Focal Seizures (Misra et al) Poster Number: 1.400 Title: Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Multicenter Study in a Multinational Asian Population (Pradhan et al) Poster Number: 1.404 Title: Efficacy of Adjunctive Cenobamate by Focal Seizure Subtypes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (Ferrari et al) Poster Number: 1.405 Title: Cenobamate Maintenance Dose Range Among Patients in the United States: A Retrospective, Real-World Analysis (Wade et al) Poster Number: 1.436 Title: Clarification of the Mechanism of Action of Cenobamate (Sankar et al) Poster Number: 1.437 II. Poster Session 2: Sunday, Dec. 8; author presentations from 12 PM – 2 PM Title: Incidence and Prevalence of Cardiac Arrhythmias with Epilepsy Drugs (Crumb et al) Poster Number: 2.410 Title: Potential of Cenobamate as a Broad-Spectrum Antiseizure Medication (Melnick et al) Poster Number: 2.412 Title: The Effect of Cenobamate on Responsive Neurostimulation Epileptiform Events (Aboumatar et al) Poster Number: 2.415 Title: Wide Range of Cenobamate Doses Associated With Initial Seizure Freedom in Patients With Uncontrolled Focal Seizures: Post-hoc Analysis of a Phase 3, Multicenter, Open-Label Study (Rosenfeld et al) Poster Number: 2.378 About SK Life Science, Inc. and SK Biopharmaceuticals Co., Ltd. SK Life Science, Inc., with headquarters in Paramus, New Jersey, is a U.S. subsidiary of SK Biopharmaceuticals Co., Ltd., a pioneering South Korean company in drug development and commercialization. Together, they are advancing innovative treatments for central nervous system (CNS) disorders and oncology, with eight compounds currently in development. Utilizing target-based drug discovery, high-throughput organic screening/high content screening, computer-aided drug design, and combinatorial chemistry, the companies drive R&D efforts in biology/discovery, medicinal chemistry, pharmacology, and clinical development. For more information, visit . SK Biopharmaceuticals Co., Ltd. is part of SK Group, South Korea's second-largest conglomerate. SK Group is a collection of global industry-leading companies driving innovations in energy, advanced materials, biopharmaceuticals and digital business. Based in Seoul, SK invests in building sustainable businesses around the world with a shared commitment to reducing global greenhouse gas emissions. SK companies combined have $151 billion in global annual revenue and employ more than 100,000 people worldwide. SK Group is one of TIME's 100 Most Influential Companies of 2023. 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 about SK Inc., visit . For more information about SK Biopharmaceuticals, visit . About XCOPRI® (cenobamate tablets) CV Cenobamate is an antiseizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. Cenobamate reduces neuronal excitability through a unique dual mechanism of action, preferentially inhibiting the persistent sodium current and enhancing GABAergic inhibition at the type A γ-aminobutyric acid (GABAA) ion channel. The precise mechanism by which cenobamate exerts its therapeutic effect is unknown. Cenobamate is marketed under the brand name XCOPRI® in the U.S. by SK Life Science, Inc. Additionally, XCOPRI is commercialized in Canada and Israel by SK Biopharmaceuticals' partners, Paladin Labs Inc. and Dexcel Ltd. Cenobamate is marketed as ONTOZRY® by Angelini Pharma S.p.A. in Europe, the UK, and Switzerland. Cenobamate is also being developed for commercialization by SK Biopharmaceuticals' partners in many other countries to meet the needs of patients living with epilepsy, including Dong-A ST Co., Ltd., Eurofarma Laboratórios S.A., Hikma MENA FZE, Ignis Therapeutics, Inc. and ONO Pharmaceutical Co., Ltd. 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. 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 XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd. References Epilepsy Foundation. Who Can Get Epilepsy? . Accessed November 2024. Epilepsy Foundation. Facts & Statistics About Epilepsy. . Accessed November 2024. Epilepsy Foundation. Staying Safe. . Accessed November 2024. Epilepsy Foundation. Complications and Risks. . Accessed November 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. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 3

100 Deals associated with Cenobamate

External Link

KEGG	Wiki	ATC	Drug Bank
D11150	Cenobamate	N03A	DB06119

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Epilepsy	CA	Endo Ventures ULC	12 Jun 2023
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
Epilepsy, Generalized	Phase 3	JP	Ono Pharmaceutical Co., Ltd.	12 Jul 2022
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04690751 (CTgov)	Phase 1	Epilepsies, Partial	28	Cenobamate 200Mg Tab Fasted (Treatment A)	yluuerdjuw(uvpknpykpk) = igqzbdchgv nqrcrjbcki (jjmvwfjnbt, qsaqnhhhlx - rosdpuojvp) View more	-	12 Aug 2024
				Cenobomate Oral Suspension Fasted (Treatment B)	yluuerdjuw(uvpknpykpk) = ormlhpvheo nqrcrjbcki (jjmvwfjnbt, jotkqfoifp - hambtsbwei) View more
NCT03678753 (Pubmed \| Cochrane Database Syst Rev)	Phase 3	Drug Resistant Epilepsy Add-on	659	Cenobamate add-on therapy	mbycxikhsn(hcvgzxbvif) = jxoackleng felnwuhsvs (loxkjmktso, 1.02 - 1.27) View more	Positive	01 Aug 2024
				Placebo	mbycxikhsn(hcvgzxbvif) = dyjhnhjvox felnwuhsvs (loxkjmktso, 1.02 - 1.27) View more
EAN2024	Not Applicable	Seizures	-	Cenobamate	mpvvyxpcye(gioyrjvlbm) = pfgziofsuw phghyvliux (dqjmzgpfvi ) View more	-	28 Jun 2024
EAN2024	Not Applicable	Epilepsy	16	Cenobamate	mkzkrfxorv(pnydklytjg) = ppklkbyxoa svcrhkvjpd (gocmgyvzyr ) View more	Positive	28 Jun 2024
P1-1.001 (AAN2024)	Not Applicable	Lennox Gastaut Syndrome	76	Cenobamate	hcqfrrntmv(gyejlhbrmr) = ykfrxvspga fdfnvwsuvw (ztdjaxchup ) View more	Positive	09 Apr 2024
				Previous antiseizure medications (ASMs)	hcqfrrntmv(gyejlhbrmr) = gpuvegbxup fdfnvwsuvw (ztdjaxchup ) View more
S29.003 (AAN2024)	Not Applicable	Seizures	-	Cenobamate	szqtfipcxn(pdtgmovett) = ihctvwjxyr xvgnbxqzwp (xkwmlqplqo ) View more	Positive	09 Apr 2024
P2-1.003 (AAN2024)	Not Applicable	Seizures	176	Cenobamate	ekpnjtpjci(iauphhwutm) = lomnhmcqya qdrprbrwvs (uxbqijfgmq ) View more	Positive	09 Apr 2024
				Previous antiseizure medications (ASMs)	ekpnjtpjci(iauphhwutm) = exfmwpwafd qdrprbrwvs (uxbqijfgmq ) View more
P8-1.004 (AAN2024)	Not Applicable	Pain, Postoperative	7,835	Cenobamate	xpomfqwnrg(bgybigdkvl) = hvwhtjusjo sdiwtmrvxh (hltuivwmoc ) View more	Positive	09 Apr 2024
AAN2024	Not Applicable	-	-	Cenobamate monotherapy	hhylevqoox(wbsglstvyf) = qmwceraweo xcwoafrwbv (ftqnbuigju ) View more	-	09 Apr 2024
NCT02535091 (Phase III, Multicenter, Open-Label Study, Pubmed \| Drugs Aging)	Phase 3	Seizures	1,340	Cenobamate	sxfsyzzkss(edyzqodebc) = somnolence and dizziness in overall patients, and somnolence, dizziness, fall, fatigue, balance disorder, and upper respiratory tract infection in older patients yvicqzqhql (dfsdvbxsbl ) View more	Positive	01 Mar 2024
				Placebo

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