SK Life Science to Host Symposium and Present New Data at the American Epilepsy Society (AES) 2023 Annual Meeting
28 Nov 2023
Drug ApprovalPhase 1Phase 3
SK Life Science will host the "Impact of Continued Seizures and Strategies for Seizure Reduction/Freedom" Symposium, an expert discussion led by world-renowned epileptologists, and present ten posters to unveil new information for healthcare providers
PARAMUS, N.J., Nov. 28, 2023 /PRNewswire/ -- SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders and oncology, will present data on cenobamate at the American Epilepsy Society (AES) Annual Meeting, to be held December 1-5, 2023, in Orlando, Florida.
"We recognize that the path to seizure management can be challenging for those living with epilepsy," said Louis Ferrari, BS, RPh, MBA, Vice President of Medical Affairs at SK Life Science. "Our participation at AES, from our symposium to our data, will offer valuable information to providers so they have updated information to address their patients' needs. This includes insights on potential solutions for challenges like medication delivery and administration."
Symposium will discuss unmet need for seizure freedom in patients with epilepsy
SK Life Science will host a symposium titled 'Impact of Continued Seizures and Strategies for Seizure Reduction/Freedom' which will be held on Saturday, December 2 at 6:00 p.m. ET, in the Plaza Ballroom H of the West Concourse, Orange County Convention Center.
The symposium will discuss currently available strategies for reducing and achieving seizure freedom, the need to better understand unmet needs for achieving seizure freedom, the impact of continued seizures on patients, evidence-based treatment adjustments before patients consider surgery, and the various treatment options available to support patients in their epilepsy journey.
Experts presenting at the symposium include:
Danielle Becker, MD, MS, FAES, Division Director of Epilepsy, Associate Professor of Neurology, The Ohio State University Wexner Medical Center, Columbus, Ohio
Pavel Klein, MB BChir Director, Mid-Atlantic Epilepsy & Sleep Center, Bethesda, Maryland
Gregory Krauss, MD, Professor, Department of Neurology, Johns Hopkins University School of Medicine Baltimore, Maryland
Patrick Kwan, BMedSci, MB BChir, PhD, FRACP, Department of Neuroscience Central Clinical School, Monash University Monash Institute of Medical Engineering Epilepsy Unit, Alfred Hospital, Melbourne, Australia
Data highlights and poster presentations
The ten posters presented at AES 2023 span a wide range of topics that include a claim-based analysis on effectiveness of cenobamate as a monotherapy and a retrospective claim-based analysis on the comparative effectiveness of cenobamate in reducing hospitalizations in patients with focal seizures.
The following is a guide to the SK Life Science-sponsored poster presentations:
Title: Cenobamate for Treatment of Pediatric Patients With Focal Epilepsy: Design of Phase I Studies With An Open-Label Extension (Vashi et al)
Poster Number: 1.280
Session & Date: Poster Session 1; Saturday, December 2
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)
Poster Number: 1.278
Session & Date: Poster Session 1; Saturday, December 2
Title: Long-Term Efficacy of Cenobamate by Focal Seizure Subtype: Post-hoc Analysis of an Open-Label Extension Study (Nisman et al)
Poster Number: 1.310
Session & Date: Poster Session 1; Saturday, December 2
Title: Relative Bioavailability of Cenobamate 200 mg Administered as a Crushed Tablet Either Orally or via a Nasogastric Tube Versus an Intact 200 mg Cenobamate Tablet (Laramy et al)
Poster Number: 2.257
Session & Date: Poster Session 2; Sunday, December 3
Title: Cenobamate Use as Monotherapy: A Retrospective Claims-Based Analysis (Becker et al)
Poster Number: 2.292
Session & Date: Poster Session 2; Sunday, December 3
Title: Effectiveness of Cenobamate in Postsurgical Patients: A Retrospective Claims-Based Analysis (Pellinen et al)
Poster Number: 2.293
Session & Date: Poster Session 2; Sunday, December 3
Title: Comparative Effectiveness of Cenobamate in Reducing Hospitalizations in Patients With Focal Seizures: A Retrospective Claims-Based Analysis (Urban et al)
Poster Number: 2.294
Session & Date: Poster Session 2; Sunday, December 3
Title: Increased Incidence of Comorbidities in Patients With Uncontrolled Epilepsy (Faught et al)
Poster Number: 2.296
Session & Date: Poster Session 2; Sunday, December 3
Title: Effectiveness of Cenobamate in Pediatric Patients With Intractable Focal Seizures: A Retrospective Claims-Based Analysis (Labiner et al)
Poster Number: 2.297
Session & Date: Poster Session 2; Sunday, December 3
Title: Effectiveness of Cenobamate in Pediatric Patients With Lennox-Gastaut Syndrome: A Retrospective Claims-Based Analysis (Keough et al)
Poster Number: 2.298
Session & Date: Poster Session 2; Sunday, December 3
About XCOPRI® (cenobamate tablets) CV
Cenobamate is an anti-seizure 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.
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 weaknessweaknessweaknessweaknessweaknessweaknessweakness, severe muscle pain, frequent infections, or infections that do not go away.
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.
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:
DRUG INTERACTIONS:
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 www.aedpregnancyregistry.org.
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 www.fda.gov/medwatch.
DRUG ABUSE:
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 news cases each year in the country.2,3 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.4,5 People with epilepsy are at risk for accidents and other health complications, including falling, drowning, depression and sudden unexplained death in epilepsy (SUDEP).4,5 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.6
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 www.skbp.com/eng and SK Life Science's website at www.SKLifeScienceInc.com.
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.
XCOPRI® and ONTOZRY® are registered trademarks of SK Biopharmaceuticals Co., Ltd.
References
Epilepsy Foundation. SUDEP. https://www.epilepsy.com/complications-risks/early-death-sudep. Accessed October 2023.
Epilepsy Foundation. Who Can Get Epilepsy? https://www.epilepsy.com/learn/about-epilepsy-basics/who-gets-epilepsy. Accessed October 2023.
Epilepsy Foundation. Facts & Statistics About Epilepsy. https://www.epilepsy.com/learn/about-epilepsy-basics/epilepsy-statistics. Accessed October 2023.
Epilepsy Foundation. Staying Safe. https://www.epilepsy.com/learn/seizure-first-aid-and-safety/staying-safe. Accessed October 2023.
Epilepsy Foundation. Complications and Risks. https://www.epilepsy.com/learn/challenges-epilepsy. Accessed October 2023.
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. https://www.ncbi.nlm.nih.gov/pubmed/29279892. Published online December 26, 2017.
SOURCE SK Life Science, Inc.
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