Vigabatrin

2024年第四届 癫痫高峰精彩回顾 “携手克癫，共创未来”！ 前言 2024年12月21日，由中国抗癫痫协会（CAAE）与卫材药业共同主办的“第四届癫痫高峰论坛”在北京隆重举办。作为癫痫领域最盛大的聚会，本届高峰论坛汇聚了国内癫痫领域的顶尖专家与临床学者，现场参会人数超过150人。本次论坛旨在共同探讨癫痫疾病的最前沿研究成果、临床诊疗进展及与吡仑帕奈相关研究及活动启动规划。让我们重温盛会，一起见证中国癫痫学者在会上的精彩瞬间！ 开场视频 EES 大会以一段精心制作的开场视频拉开帷幕，带领参会者回顾过去五年中癫痫研究领域的主要工作及重要成就，现场气氛热烈而温情。 大会主席致辞 EES 大会主席由中国抗癫痫协会会长周东教授、中国抗癫痫协会副会长姜玉武教授共同担任，2位教授在致辞中提到“癫痫作为一种影响广泛的神经系统疾病，不仅给患者带来了极大的身心痛苦，也对其家庭乃至整个社会造成了深远的影响。期望全国的专家同道、包括相关企业组织，一起携手合作，共同推动癫痫领域的科学研究发展，改善患者的生活质量。”希望通过此次会议中各位专家的学术分享与交流碰撞出创新的火花，共同为癫痫事业的发展贡献力量。 Pathwys to Progress Progress EES 该环节由重庆医科大学附属第一医院王学峰教授、中山大学附属第七医院周列民教授担任主持；北京大学第一医院刘晓燕教授、宣武医院王玉平教授、北京大学第一医院姜玉武教授分别对于癫痫在脑电质控、睡眠、遗传学研究进展上进行了主题分享。刘晓燕教授分享了脑电质控方向在癫痫领域的诊断新进展；同时也提及不同ASM对脑电的影响需要引起临床重视。王玉平教授分享的关于睡眠的内容，从AMPA机制层面提示FYC对于伴睡眠障碍癫痫患者的用药优势。姜玉武教授分享的话题中明确提及：对于NR2F1相关的婴儿痉挛症，PER单独或者联合托吡酯很可能是比ACTH、氨己烯酸更合适的首选治疗方案。 Bridging Research to Practice EES 本场会议的第二环节由浙江大学医学院附属第二医院丁美萍教授和广州医科大学附属第二医院廖卫平教授主持。该环节中有4位专家分享临床科研工作，在科研内容分享前，首都医科大学三博脑科医院王梦阳教授代表中国抗癫痫协会药物治疗专业委员会分享了2024年的学术成果《吡仑帕奈治疗成人局灶性癫痫的中国专家共识》，该共识从临床实践出发，为第三代ASM吡仑帕奈在中国人群中的使用提出了切实可行的指导意见。山东省立医院刘学伍教授分享主题《吡仑帕奈治疗卒中后癫痫的有效性和安全性：一项多中心、真实世界研究》。本次会议还特别邀请到药学专家参与和分享，浙江儿童医院药剂科主任缪静教授带来了药学研究课题《年龄、联合药物及CYP3A4/5多态性对中国癫痫患儿吡仑帕奈暴露的影响》，从临床药学角度给癫痫治疗提出了新的思考思路。两位儿科教授分享了主题；深圳市儿童医院操德智教授分享《吡仑帕奈单药治疗儿童癫痫真实世界研究》，浙江大学医学院附属第二医院冯建华教授分享《吡仑帕奈对遗传病因的儿童癫痫疗效》内容。 MDT疑难病例讨论会 MDT讨论会环节由由复旦儿科周渊峰教授分享复杂且罕见的癫痫病例诊治经历，此环节由华中科技大学同济医学院附属同济医院朱遂强教授主持，由重庆医科大学附属儿童医院蔡方成教授、中山大学附属第一医院陈子怡教授、首都医科大学附属北京天坛医院邵晓秋教授进行病例讨论。现场讨论热烈，与会专家围绕着该病例展开了深入的交流。 吡仑帕奈作为机制独特的抗癫痫发作药物，进入中国市场后也越来越被临床广泛接受。伴随着吡仑帕奈口服混悬液的快速上市，为让临床医生充分了解混悬液的给药优势、更好的用于癫痫患者的治疗，本场会议中，由全国25家儿童医院专家共同开启了《吡仑帕奈用于低龄癫痫患儿的中国专家共识》撰写启动；也期待未来该“共识”可以帮助到更多患者。 会中也同步筹备了《病例来了-走进中抗直播间》项目启动会：中国抗癫痫协会秘书处段立嵘秘书长与卫材药业市场经理宋家慧经理共同讲解了项目进程，同时也明确了卫材药业将持续与中国抗癫痫协会深度合作的愿景，敬请期待！ 总结 本次大会在周东教授的总结中圆满结束，周教授特别提到期待未来所有癫痫领域的专家同道仍能继续相聚在EES这样高水准的学术活动中。

MAPLE GROVE, Minn., Dec. 2, 2024 /PRNewswire/ -- Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced its participation at AES 2024, the Annual Meeting of the American Epilepsy Society, from December 6-10, 2024 in Los Angeles, California, where it will present a range of events, including Innovation Pavilion presentations and two scientific posters featuring new data on its medications for infantile spasms. Upsher-Smith's parent company, Bora Pharmaceuticals Co., Ltd., recently acquired US-based Pyros Pharmaceuticals Inc., a leader in the development of enhanced specialty pharmaceuticals for rare diseases. The acquisition added VIGAFYDE™ (vigabatrin) Oral Solution to Upsher-Smith's portfolio of rare disease medications, making it the third vigabatrin formulation to be offered by Upsher-Smith, alongside VIGADRONE® (vigabatrin) Powder for Oral Solution and Tablets. VIGAFYDE™ is the first and only ready-to-use vigabatrin oral solution and is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years, where the potential benefits outweigh the potential risk of vision loss. VIGAFYDE™ is the first new drug application (NDA) approved for this condition in 15 years and represents a welcome expansion of vigabatrin treatment options, enabling customization of therapy to best meet the needs of individual patients and caregivers. Innovation Pavilion Presentations The Company also invites attendees to visit the Innovation Pavilion for informative presentations on vigabatrin between the hours of 12:30 pm – 1:30 pm on Saturday, December 7, 2024, Sunday, December 8, 2024, and Monday, December 9, 2024. The Innovation Pavilion is located in the exhibit hall (South Hall H, Level 1). Scientific Posters for Presentation Include: Dissolution and Stability of Vigabatrin Powder in Water, Fruit Juice, Milk, and Infant Formula Poster 2.407; Sunday, December 8, 2024; 10 a.m. – 4 p.m. PST Authors to present 12 p.m. to 2 p.m. Los Angeles Convention Center, South Lobby, Street Level, South Hall H, Level 1 Comparison of Vigabatrin Oral Solution Versus Vigabatrin (SABRIL®) Powder for Oral Solution in Infantile Spasms by Caregivers Poster 2.398; Sunday, December 8, 2024; 10 a.m. – 4 p.m. PST Authors to present 12 p.m. to 2 p.m. Los Angeles Convention Center, South Lobby, Street Level, South Hall H, Level 1 Abstracts of the poster presentations can be found online at . To schedule an interview with a study author, please contact Elizabeth Likly at [email protected]. Upsher-Smith representatives will also be available at its commercial booths throughout the conference to engage with clinicians about its products. Products include the new ready-to-use vigabatrin solution, VIGAFYDE™ at Booth #1439, and VIGADRONE® Powder for Oral Solution and Tablets and the Promise of Support™ Program, which has been providing comprehensive support to patients prescribed VIGADRONE® since 2018, at Booth #1627. About Upsher-Smith's Promise of Support™ Program Central to Upsher-Smith's commitment to rare disease communities is its Promise of Support™ Program, ensuring comprehensive assistance for patients, caregivers, and healthcare providers throughout the treatment journey. For nearly a decade, the program has offered resources for uninterrupted medication supply, prior authorization support, patient education materials, collaboration with a leading specialty pharmacy partner, and streamlined prescribing and enrollment procedures. It also includes copay assistance for eligible patients to help lessen the financial burden on patients and their families. To learn more about Upsher-Smith, its products, and the Promise of Support™ Program visit: . Vigabatrin REMS All vigabatrin products are governed by a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA. The Vigabatrin REMS ensures that patients and healthcare providers make informed risk-benefit decisions about its use. Healthcare providers must be enrolled in the Vigabatrin REMS to prescribe these products, and patients must be enrolled to receive them. IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin) What is the most important information I should know about VIGAFYDE? VIGAFYDE can cause serious side effects, including: Permanent vision loss: VIGAFYDE can damage the vision of anyone who takes it. Some babies can have severe loss, particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, your baby may only be able to see things straight in front of them (sometimes called "tunnel vision"). Your baby also may have blurry vision. If this happens, it will not get better. Tell your healthcare provider right away if your baby might not be seeing as well as before starting VIGAFYDE or is acting differently than normal. Vision loss in babies: Because of the risk of vision loss, VIGAFYDE is used in babies 1 month to 2 years of age with infantile spasms only when you and your healthcare provider decide that the possible benefits of VIGAFYDE are more important than the risks. Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe. It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting VIGAFYDE or within 4 weeks after starting VIGAFYDE, and every 3 months after that until VIGAFYDE is stopped. Your baby also should have a vision test about 3 to 6 months after VIGAFYDE is stopped. Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGAFYDE, but they will not be able to watch for any vision loss. Even if your baby's vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby's vision before it is severe and permanent. All babies who take VIGAFYDE: Are at risk for permanent vision loss with any amount of VIGAFYDE. The risk of vision loss may increase with higher doses of VIGAFYDE, and the longer it is taken. It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped. Because VIGAFYDE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will explain the details of the Vigabatrin REMS to you. For more information, go to or call 1-866-244-8175. Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS): brain pictures taken by MRI show changes in some babies after they are given VIGAFYDE. It is not known if these changes are harmful. What are the possible side effects of VIGAFYDE? VIGAFYDE can cause serious side effects, including sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable) and weight gain without swelling. Serious side effects that happen in adults who take vigabatrin and are not known if they will happen in babies are low red blood cell counts, nerve problems, and swelling. Tell your baby's healthcare provider right away if your baby's seizures get worse. The most common side effects of VIGAFYDE in babies include sleepiness, ear infection, swelling of the bronchial tubes, and irritability. Tell your healthcare provider if your baby has any side effect that bothers them or that does not go away. These are not all the possible side effects of VIGAFYDE. Do not stop taking VIGAFYDE suddenly. This can cause serious problems. Talk to your healthcare provider for directions on how to stop treatment. What should I tell my healthcare provider before starting VIGAFYDE? Before giving VIGAFYDE to your baby for IS, inform your healthcare provider about all your baby's medical conditions. This includes whether your baby has ever had an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing, as well as any history of vision problems, or kidney issues. Tell your healthcare provider about all the medicines your baby takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interactions between VIGAFYDE and other medicines could lead to side effects. You may report side effects to the FDA at or call 1-800-FDA-1088 or Pyros at 1-855-406-1010. Please see full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for Use for additional Important Safety Information. WHAT IMPORTANT SAFETY INFORMATION SHOULD I KNOW ABOUT VIGADRONE® (vigabatrin)? Because VIGADRONE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this Program to you. VIGADRONE can damage the vision of anyone who takes it. Some people can have severe loss, particularly to their ability to see to the side when looking straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called "tunnel vision"). You may also have blurry vision. If this happens, it will not get better. Tell your healthcare provider right away if you (or your child): might not be seeing as well as before starting VIGADRONE; start to trip, bump into things, or are more clumsy than usual; are surprised by people or things coming in front of you that seem to come out of nowhere; or if your baby is acting differently than normal. These changes can mean that vision damage has occurred. Regular vision testing is recommended. It is recommended that your healthcare provider test your (or your child's) vision before or within 4 weeks after starting VIGADRONE, and at least every 3 months during treatment until VIGADRONE is stopped. It is also recommended that vision be tested about 3 to 6 months after VIGADRONE is stopped. It is difficult to test vision in babies, but to the extent possible, all patients should have their vision tested. Your healthcare provider will determine if testing can be done. Regular vision testing is important because damage can happen before any changes are noticed. Vision tests cannot prevent the vision damage that can happen with VIGADRONE, but they do allow VIGADRONE to be stopped if vision has gotten worse, which usually will lessen further damage. Even these regular vision tests may not show vision damage before it is serious and permanent. Parents, caregivers, and healthcare providers may not recognize the symptoms, or find vision loss in patients, until it is severe. If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE for you (or your child). Some people are not able to complete vision testing. If vision testing cannot be done, your healthcare provider may continue prescribing VIGADRONE, but will not be able to watch for any vision loss. Magnetic resonance imaging (MRI) changes in patients with infantile spasms (IS). Brain pictures taken by MRI show changes in some patients after they are given VIGADRONE. It is not known if these changes are harmful. A type of swelling in the brain called intramyelinic edema (IME) has been seen in autopsy examination of patients treated with vigabatrin. Risk of suicidal thoughts or actions. Like other antiepileptic drugs, VIGADRONE may cause suicidal thoughts and actions in some people (about 1 in 500 people). Call a healthcare provider right away if you (or your child) have any symptoms, especially sudden changes in mood, behaviors, thoughts or feelings, and especially if they are new, worse, or worry you. Do not stop VIGADRONE without first talking to a healthcare provider. Stopping VIGADRONE suddenly can cause seizures that will not stop. VIGADRONE can cause serious side effects such as low red blood cell counts (anemia), sleepiness and tiredness, nerve problems, weight gain, and swelling. Because VIGADRONE causes sleepiness and tiredness, do not drive, operate machinery, or perform any hazardous task, unless it is decided that these things can be done safely. VIGADRONE may make certain types of seizures worse. Tell your healthcare provider right away if seizures get worse. Before starting VIGADRONE, tell your doctor about all of your (or your child's) medical conditions including depression, mood problems, suicidal thoughts or behavior, any allergic reaction to VIGADRONE, vision problems, kidney problems, low red blood cell counts (anemia), and any nervous or mental illnesses. Tell your doctor about all the medicines you (or your child) take. If you are breastfeeding or plan to breastfeed, VIGADRONE can pass into breast milk and may harm your baby. Breastfeeding is not recommended. If you are pregnant or plan to become pregnant, VIGADRONE can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE while you are pregnant. The most common side effects of VIGADRONE in adults include: blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking (tremor) and tiredness. The most common side effect of VIGADRONE in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults. The most common side effects of VIGADRONE in babies include: sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable), swelling in the bronchial tubes (bronchitis), ear infection and irritability. Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. This is the most important information to know about VIGADRONE, but it is not all the safety information. For more information, ask your healthcare provider or pharmacist, or please see the VIGADRONE Medication Guide, full Prescribing Information including Boxed Warning for risk of permanent vision loss, and Instructions for Use. You can also visit VIGADRONE.com, upsher-smith.com or call 1-888-650-3789. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-332-1088. WHAT IS VIGADRONE? VIGADRONE® (vigabatrin) is a prescription medicine used to treat: Infantile Spasms (IS) in patients 1 month to 2 years of age, if you and your healthcare provider decide the possible benefits of taking VIGADRONE are more important than the possible risk of vision loss. Refractory Complex Partial Seizures (CPS) in adults and children 2 years and older with refractory complex partial seizures (CPS) along with other treatments if: The CPS do not respond well enough to several other treatments, and You and your healthcare provider decide the possible benefit of taking VIGADRONE is more important than the risk of vision loss. VIGADRONE should not be the first medicine used to treat CPS. About Upsher-Smith Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit . About Bora Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Bora is dedicated to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. For more information, visit . VIGADRONE and Promise of Support are trademarks of Upsher-Smith Laboratories, LLC. VIGAFYDE is a trademark of Pyros Pharmaceuticals, Inc. SOURCE Upsher-Smith Laboratories, LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED