Latest news with #XCOPRI®
Yahoo
19-05-2025
- Health
- Yahoo
SK Life Science Launches Its Second National Ad, Continuing to Lead with the Only Direct-to-Consumer Commercial for an Anti-Seizure Drug in the U.S.
"Road to Reduction" Begins Airing Today Raising Awareness of XCOPRI® (cenobamate tablets) CV and the Journey to Seizure Management for People Living with Epilepsy PARAMUS, N.J., May 19, 2025 /PRNewswire/ -- SK Life Science, Inc., a global leader in developing treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., today announced the launch of a new nationwide direct-to-consumer (DTC) commercial titled "Road to Reduction" for XCOPRI® (cenobamate tablets) CV, a once-daily prescription medication for adults with partial-onset seizures. The commercial aims to raise national awareness of epilepsy, reduce stigma, and empower patients to have informed conversations with their doctors about reducing seizures. The campaign captures a powerful reality for many in the epilepsy community: the journey to seizure control is often marked by fear, isolation, and setbacks. The campaign, airing across streaming TV, digital, social, and healthcare platforms to meet people where they are, acknowledges that while patients want to reduce their seizures, they also carry a lot of fear – fear of trying a new medication and a fear of going backwards. At its core, the campaign aims to reframe the treatment journey for patients living with epilepsy. "At SK Life Science, we've always been committed to elevating the voices of people living with epilepsy and advocating for patient voices to be heard when choosing a treatment option," said Chris Fanale, Executive Director, Marketing, SK Life Science. "This campaign reflects a deeply authentic understanding of what patients and caregivers face daily – and encourages them to talk with their doctors about options that may help reduce seizures, even in people who have been living with uncontrolled seizures for a long time." The "Road to Reduction" spot follows the story of an adult male navigating the challenges of epilepsy alongside his father. Their road trip – metaphorically and literally – symbolizes the emotional journey of finding the right treatment path, despite facing many unknowns. Imagery such as a downed tree and even driving in reverse represents the emotional journey of living with uncontrolled seizures and the fear of exploring new treatments. Ultimately, the ad aims to deliver a message of resilience and renewed possibility: that significant seizure reduction could be just ahead. Through the creation of this campaign, SK Life Science was committed to challenging stigma, elevating patient voices, raising awareness, and encouraging meaningful conversations between patients and their healthcare providers. This campaign is about redefining what's possible for people living with epilepsy. To learn more about XCOPRI, visit About SK Life Science, Inc. and SK Biopharmaceuticals Co., 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) CVCenobamate 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 1-888233-2334 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 Cleveland Clinic. Epilepsy. Accessed May 2025. Epilepsy Foundation. Facts & Statistics About Epilepsy. Accessed May 2025. Epilepsy Foundation. Staying Safe. Accessed May 2025. Epilepsy Foundation. Complications and Risks. Accessed May 2025. 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. View original content to download multimedia: SOURCE SK Life Science, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Globe and Mail
14-04-2025
- Health
- Globe and Mail
Paladin Pharma and the pan-Canadian Pharmaceutical Alliance (pCPA) Successfully Complete Negotiations for Public Funding of XCOPRI® (cenobamate tablets)
MONTREAL , /CNW/ -- Paladin Pharma is pleased to announce the successful completion of negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for the public funding of XCOPRI ® (cenobamate tablets) as adjunctive therapy in the management of focal seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy. 1 "We are pleased to have successfully concluded the negotiation process with the pCPA," said Livio Di Francesco , Vice President & General Manager of Paladin Pharma. "This is a significant milestone to ensure that appropriate Canadian epilepsy patients have broad and equitable access to XCOPRI, and it is exciting news for the epilepsy community across Canada ." Since launch, the Paladin team has already achieved early access for XCOPRI through private payer reimbursement, with approximately 85% of privately insured lives in Canada having access to the treatment. The next step in the public reimbursement process will be for provincial, territorial, and federal government organizations to make their respective final decisions on public reimbursement for their regions. Paladin looks forward to working with each of them to make XCOPRI available as soon as possible through public drug plans. "We hope the jurisdictions move as quickly as possible," added Di Francesco . "Uncontrolled epilepsy can have a significant impact on a patient's life, and we look forward to the day when all appropriate patients in Canada can have access to this important treatment option." About Epilepsy 2-4 Epilepsy is a chronic neurological condition affecting ~300,000 Canadians. It is characterized by recurrent, unprovoked seizures. While there are many different types of seizures, they can be grouped into two broad categories – generalized seizures and focal seizures – based on where in the brain the seizure activity starts. Focal seizures (also called partial-onset seizures) affect ~60% of people with epilepsy. While many people with epilepsy respond to anti-seizure medication, ~30% of patients continue to experience seizures, despite treatment with currently available medication options. About XCOPRI XCOPRI received Health Canada approval in June 2023 for use as adjunctive therapy in the management of focal seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy. It is taken orally, once daily. 5 XCOPRI is a new generation of anti-seizure medication (ASM) discovered and developed by SK Biopharmaceuticals and SK Life Science. It is a novel molecule with a dual mechanism of action. In pre-clinical studies, XCOPRI has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a modulator of the γ-aminobutyric acid (GABAA) ion channel. 5-6 The efficacy and safety of XCOPRI for the treatment of adults with uncontrolled partial-onset seizures (also known as focal-onset seizures) were assessed in two randomized, placebo-controlled, double-blind clinical trials (C013 and C017). 6-7 The long-term safety of cenobamate in this population has been studied in an open-label safety study (C021). 8 During Studies C013 and C017, a total of 441 patients were exposed to XCOPRI. In both studies, the primary efficacy endpoint was median percent reduction from baseline in seizure frequency per 28 days. The key secondary endpoint was responder rates, defined as the proportion of patients with 50% or greater reduction in seizure frequency. XCOPRI significantly reduced seizure frequency and demonstrated a significantly higher ≥50% responder rate compared to placebo. In Study C013, 28.3% of patients in the cenobamate group reported being seizure free during the maintenance phase (placebo: 8.8%). Consult the Product Monograph for complete efficacy and safety information. Cenobamate is currently marketed in the U.S. as XCOPRI ® and in Europe under the trademark ONTOZRY ®. About Paladin Pharma Paladin Pharma Inc., headquartered in Montreal, Canada , is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. Paladin has a focused marketing, medical, and sales organization that has helped it evolve into one of Canada's leading specialty pharmaceutical companies. Paladin is an operating company of Endo, Inc. For more information visit Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements including, but not limited to, the statements by Mr. Di Francesco and any statements relating to marketing approval, public funding and reimbursement, product efficacy, potential treatments or indications, therapeutic outcomes or treatment responses, and any statements that refer to expected, estimated or anticipated future results or that do not relate solely to historical facts. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intends," "guidance," "future," "potential" or similar expressions are forward-looking statements. Because these statements reflect Paladin's or Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties, some of which Paladin and Endo may not currently be able to predict. Although Paladin and Endo believe that these forward-looking statements and other information are based upon reasonable assumptions and expectations, readers should not place undue reliance on these or any other forward-looking statements and information. Actual results may differ materially and adversely from current expectations based on a number of factors, including, among other things, the following: changes in competitive, market or regulatory conditions; changes in legislation or regulations; the ability to obtain and maintain adequate protection for intellectual property rights; the impacts of competition; the timing and uncertainty of the results of the public funding processes; health care and cost containment reforms, including government pricing, tax and reimbursement policies; litigation and other disputes; consumer and physician acceptance of current and new products; the performance of third parties upon whom we rely for goods and services; issues associated with our supply chain; the ability to develop and expand our product pipeline, to launch new products and to continue to develop the market for our products; and the effectiveness of advertising and other promotional campaigns. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws. Additional information concerning risk factors, including those referenced above, can be found in press releases issued by Endo and in Endo's public filings with the U.S. Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Endo's most recent Form 10-K and in Endo's final prospectus filed pursuant to Rule 424(b) under the Securities Act of 1933, as amended, in connection with Endo's Form S-1/A. References: pCPA, "Xcopri (cenobamate)", available at Xcopri (cenobamate) | pCPA Accessed April 4, 2024 Canadian Epilepsy Alliance. Accessed April 4, 2024 . Public Health Agency of Canada . Epilepsy in Canada . 2021. Accessed April 4, 2025 . Epilepsy Canada . Accessed April 4, 2025 . XCOPRI ® Product Monograph. Paladin Pharma Inc. May 15, 2024 . Chung SS, et al. Neurology. 2020;94:e2311-e2322. Krauss GL, et al. Lancet Neurol. 2020;19:38-48. Sperling MR, et al. Epilepsia. 2020;61(6):1099-1108.
Yahoo
04-04-2025
- Health
- Yahoo
SK Life Science, Inc. to Showcase Important XCOPRI® (cenobamate tablets) CV Data on Responsive Neurostimulation Epileptiform Events at the 77th American Academy of Neurology (AAN) Annual Meeting
PARAMUS, N.J., April 4, 2025 /PRNewswire/ -- SK Life Science, Inc., a global leader in developing treatments for central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals Co., Ltd., will present meaningful encore data on XCOPRI® (cenobamate tablets) CV, an anti-seizure medication, at the 77th American Academy of Neurology (AAN) Annual Meeting, taking place April 5-9, 2025, in San Diego, California. This presentation reinforces the growing body of clinical and real-world evidence supporting cenobamate's role in reducing seizure activity and optimizing epilepsy management. "Our goal at SK Life Science is to redefine seizure management by advancing research and education that translates into meaningful improvements for people living with epilepsy," said Louis Ferrari, BS, RPh, MBA, vice president, Medical Affairs at SK Life Science, Inc. "Seizure freedom remains an elusive, yet critical, objective for many patients, and this research offers valuable insights into how RNS data can be used as an objective measure to assess the efficacy of XCOPRI, and possibly other add-on anti-seizure medications." At AAN 2025, SK Life Science will highlight the impact of cenobamate on RNS epileptiform events. A retrospective, multicenter, observational, 24-week study among 37 patients with uncontrolled seizures showed a meaningful reduction in epileptiform events and clinically reported seizures during adjunctive cenobamate treatment. Results from this analysis support, through electrocorticographic data and observation of clinical seizures, the effectiveness of cenobamate in the treatment of focal seizures. Additional clinical and real-world data exploring cenobamate's efficacy, safety, and therapeutic potential in diverse patient populations will also be presented. Select SK Life Science posters presented at 2025 AAN include: Title: The Effect of Cenobamate on Responsive Neurostimulation Epileptiform Events (Aboumatar et al) Session: P5: Epilepsy/Clinical Neurophysiology (EEG): Neuromodulation Devices and Seizure TrackingDate/Time: Monday, April 7, from 8:00 a.m. – 9:00 a.m. PTAbstract Number: 2991 Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Cenobamate in Asian Patients With Focal Seizures, With Optional Open-Label Extension (Misra et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical TrialsDate/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PTAbstract Number: 1406 Title: Early Response Rates With Adjunctive Cenobamate in Uncontrolled Focal Seizures: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study in a Multinational Asian Population (Pradhan et al) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical TrialsDate/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PTAbstract Number: 1404 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) Session: P8: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Clinical TrialsDate/Time: Tuesday, April 8, from 8:00 a.m. – 9:00 a.m. PTAbstract Number: 1408 Title: Clarification of the Mechanism of Action of Cenobamate (Sankar et al) Session: P9: Epilepsy/Clinical Neurophysiology (EEG): Anti-seizure Medications: Mechanisms and PharmacologyDate/Time: Tuesday, April 8, from 11:45 a.m. – 12:45 p.m. PTAbstract Number: 1381 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) Session: P12: Epilepsy/Clinical Neurophysiology (EEG): Retrospective Studies, Reviews, and Meta-analyses in EpilepsyDate/Time: Wednesday, April 9, from 11:45 a.m. – 12:45 p.m. PTAbstract Number: 158 A complete list of SK Life Science abstracts presented at AAN 2025 can be found here. In addition to these scientific presentations, SK Life Science, Inc. will host a booth (#223) in the Exhibit Hall, open from 11:30 a.m. PT on Sunday, April 6, 2025, until 4 p.m. PT on Wednesday, April 9, 2025. Attendees are encouraged to visit the booth to learn more about SK Life Science's commitment to epilepsy research and patient care. 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 1-888233-2334 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 Cleveland Clinic. Epilepsy. Accessed April 2025. Epilepsy Foundation. Facts & Statistics About Epilepsy. Accessed April 2025. Epilepsy Foundation. Staying Safe. Accessed April 2025. Epilepsy Foundation. Complications and Risks. Accessed April 2025. 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. View original content to download multimedia: SOURCE SK Life Science, Inc. Sign in to access your portfolio
