Eptinezumab-JJMR

LTMag LT Magazine 追科学，赚到钱 Follow Science Find Money 第一时间收到深度推送，无广告，不追热点 点击蓝色字体 · 关注「LT Magazine」 Jon · Lab to Market· 2026.06.04 疼痛药物研发的核心矛盾，从来不是"止不住痛"，而是"止住痛的同时让人上瘾"。Suzetrigine把镇痛靶点搬到外周神经系统，从机制上绕开了成瘾性——这不是一款新药的胜利，是一个技术路线的验证。 疼痛，是日常生活中一位不请自来的常客。 它是加班到深夜时太阳穴那根跳动的血管，是生理期小腹深处那种钝重的坠胀，是拔完智齿后麻醉褪去的烧灼，也是运动扭伤后关节传来的锐利刺痛。它们不是大病，却足够让人心烦意乱，甚至失去一整天的工作能力。 然而，人类与疼痛的战争，远比我们想象得更为惨烈。在过去二十多年间，阿片类药物——这个曾被寄予厚望的"止痛神药"——在缓解疼痛的同时，也将数以百万计的患者推向了依赖、滥用甚至死亡的深渊。疼痛：被低估的"流行病" 在讨论药物之前，我们必须先正视一个被长期忽视的事实：疼痛本身，已经成为一场全球性的公共卫生危机。头痛：近四分之一中国人的困扰 紧张型头痛——那种双侧头部压迫感或紧箍样疼痛——是全球患病率第二高的疾病，仅次于龋齿，全球患病率高达 11% 至 45%。 在中国，紧张型头痛的年患病率为 10.8%，占原发性头痛的 45.3%，是最常见的头痛亚型。而更广泛的流行病学调查结果显示，中国内地 18 至 65 岁人群中，原发性头痛的发病率高达 23.8%——这意味着，将近四分之一的中国人正不同程度地遭受头痛困扰。痛经：每月一次的"隐形失能" 2026年发表的一项覆盖 70 个国家的系统综述与 meta 分析显示，全球痛经合并患病率高达 71.3%，其中原发性痛经患病率为 73%，继发性痛经为 35%。 聚焦中国，数据同样令人心惊。我国育龄女性痛经整体发病率在 30% 至 80% 之间，青春期女性超过 65%，其中中重度顽固性痛经约占 20%。更值得关注的是痛经造成的社会经济代价：据相关研究数据，中国每年因痛经导致的时间损失高达 1.4 亿小时。阿片类药物：止痛神药的"黑暗面" 阿片类药物的作用机制本身是精妙的：它们通过作用于中枢神经系统的阿片受体（μ、κ、δ受体），在产生强大镇痛效果的同时，也触发了大脑的奖赏通路，带来欣快感。 然而，正是这同一套机制，伴随着一系列严重副作用：恶心呕吐、便秘、呼吸抑制，以及最致命的——心理依赖，即成瘾。 美国CDC于2025年5月公布的初步统计数据显示，2024年美国因过量用药死亡人数为 80,391 人。其中，因服用以芬太尼为主的合成阿片类药物致死人数约为 48,400 人，占总死亡人数的 60%。 这并非一个孤立的数字。此前发表于《The Journal of the American Medical Association》的研究指出，美国阿片危机自1999年以来已累计导致超过 100 万人死亡。 据Vertex公司和《Scientific American》2024年的报道，美国每年约有 4,000 万人服用阿片类药物治疗急性疼痛，其中约 85,000 人因此患上阿片类药物使用障碍（OUD）——一种以强迫性觅药和用药为特征的精神疾病。 正如北京协和医院麻醉科主任医师黄宇光所言："药物就是毒物，只看如何掌握。"在临床实践中，疼痛科医生不得不面对一个残酷的悖论：镇痛效果越强的阿片类药物，其副作用和成瘾风险也越严重。非阿片类创新药：疼痛治疗的"觉醒时代" 正是在阿片危机的巨大阴影下，全球制药界开启了一场针对疼痛机制的基础科学攻关。转折点出现在2025年初。1. Suzetrigine（Journavx）：20多年来首个新机制非阿片类止痛药 2025年1月30日，美国食品药品监督管理局（FDA）正式批准了Vertex（福泰制药）的创新药物 Journavx（通用名：Suzetrigine）上市，用于治疗成人中度至重度急性疼痛。 这是 FDA 二十多年来批准的首个基于全新作用机制的止痛药物。 机制：把疼痛信号"拦截"在通往大脑之前 传统阿片类药物作用于中枢阿片受体，在抑制疼痛的同时激活大脑奖赏系统——这正是成瘾性的根源。而Suzetrigine另辟蹊径——它选择性抑制外周痛觉神经元（伤害感受器）上的 NaV1.8 电压门控钠通道，阻断疼痛信号的动作电位产生和传递，将疼痛信号"拦截"在通往大脑的途中。 这一机制的临床意义在于：由于药物不通过阿片受体发挥作用，目前在临床研究中没有证据表明其具有成瘾性。 据统计，全球已有超过 30 款靶向 NaV1.8 的在研新药正在开发中。Suzetrigine只是打开了第一扇门。2. 美洛昔康注射液（普坦宁/QAMZOVA）：长效镇痛的"中国力量" 2025年4月30日，清普生物自主研发的美洛昔康注射液（Ⅱ）（中国商标名：普坦宁，美国商品名：QAMZOVA）获得中国国家药品监督管理局（NMPA）和美国FDA的上市批准，实现"中美双批"。 这是国内首款获得FDA上市许可的镇痛新药，也是全球唯一在售的长效非甾体抗炎药（NSAID）注射液。 核心突破："长效"二字的含金量 传统术后镇痛注射药物通常需要一日多次注射或通过留置导管持续给药。而普坦宁单次注射即可实现 24 小时持续强效镇痛，尤其是在药效末期（18-24小时）仍保持显著效果。 在骨科手术的III期临床研究中，普坦宁组在48小时内显著降低吗啡用量 56.3%；在腹部手术中该数值为 46.0%——这在同类NSAID中是最高的吗啡节省率。3. CGRP靶向药物：偏头痛预防的精准武器 2025年11月，灵北公司就偏头痛预防性治疗药物 Vyepti（通用名 eptinezumab）向中国国家药品监督管理局药品审评中心（CDE）提交了新药上市申请（NDA）。 与此同时，辉瑞旗下的扎维吉泮（Zavegepant）鼻喷雾剂——全球首个CGRP受体拮抗剂鼻喷剂型——也以其"15 分钟起效"的超快速度引发关注。在III期临床中，患者接受单次鼻内给药后15分钟即显示出疼痛缓解效果，30分钟可恢复正常活动，疗效持续48小时。4. TRD208：多靶点多模式镇痛的未来 2025年10月，中国生物制药旗下泰德制药的1类创新药注射用TRD208启动首个临床试验。TRD208是一款非阿片类多靶点多模式镇痛创新药，可同时靶向NaV1.7和NaV1.8等多个疼痛相关传导通路。 这意味着它不仅能缓解急性疼痛，还有望降低急性疼痛诱发神经病理性疼痛的风险。市场前景：一个高速增长的新赛道 根据Research And Markets于2025年12月发布的全球预测报告： 2024 → 2032 年非阿片类治疗药物市场规模 2024：407.7 亿美元 → 2025：437.8 亿美元 2032（预测）：737.2 亿美元 2025-2032年 CAGR：7.68% 这个数字看起来不如AI制药那样爆炸，但它的特殊性在于：这是一个被监管高度约束的市场，7.68%的CAGR代表的是真实临床需求的稳步释放，而非资本泡沫。LT 视角 判断 疼痛药物研发的核心矛盾，从来不是"止不住痛"，而是"止住痛的同时让人上瘾"。 阿片类药物的本质是用"奖赏通路劫持"换取镇痛效果——这是工程上的偷懒，不是解决方案。Suzetrigine把镇痛靶点搬到外周神经系统（NaV1.8通道），从机制上绕开了成瘾性——这不是一款新药的胜利，是一个技术路线的验证：你可以用工程手段，把"疗效"和"成瘾"解耦。 框架 这件事应该放进"药物研发从中枢走向外周"的大坐标系里理解。 过去二十年，药物研发的一个隐秘主线是：尽可能在外周解决问题，避免穿越血脑屏障（BBB）带来的副作用和成瘾风险。GLP-1受体激动剂（减肥药）不怎么进入大脑；Suzetrigine选择性作用于外周NaV1.8；就连GV-971（脑肠轴AD药物）也是从肠道出发，间接影响大脑。 未来二十年，疼痛是不是下一个GLP-1，是不是下一个消费医疗的明星赛道？我们拭目以待！ 对读者的意义 创业者：NaV1.8只是外周镇痛的第一个验证靶点，不是终点。疼痛的外周机制还有很多未解锁的节点（NaV1.7、TRPV1、P2X3等）。这些靶点的共同特征是：在外周表达丰富，在中枢表达有限——天然具备"疗效/成瘾解耦"的工程优势。 投资者：普坦宁的"中美双批"是一个值得记住的信号——中国创新药的国际化，不一定非要从PD-1这样的拥挤赛道出发。麻醉/镇痛这个"小赛道"，反而更容易拿到FDA的突破性疗法认定。 从业者：多模式镇痛（MMA）是未来十年的标准治疗方案。不是"一种药解决所有疼痛"，而是"阿片类+非阿片类+区域阻滞"的组合拳。 消费者：记住：你有权选择不依赖阿片的止痛方案。同时，如果你家中有人正在使用阿片类止痛药，请关注用药剂量和时长——"按需使用、最短疗程"是国际通用的安全原则。  监制 JON | 出版 JIN | 学术 JIE 往期精选 脑肠轴：青少年抑郁治疗新大陆 失眠药为什么是一门 6000亿的大生意？ 谁在改写护肤生意的底层逻辑？ 💬你想聊点什么？ 关于文章内容、时事热点你的困惑、或者任何想聊的话题 新文化新消费新药消费医疗消费电子 留言区见→ 长按识别二维码 → 关注「LT Magazine」 第一时间收到深度文章推送 · 无广告 · 不追热点 LT Magazine · Follow Science, Find Money · © 2026

New 12-month data from the INFUSE study show patient-reported outcomes related to multiple migraine-related cognitive symptoms in participants who failed at least one prior calcitonin gene-related peptide (CGRP)-targeted therapy 1 Six-month data from the INFUSE study was recently published in Cephalalgia Reports, an official journal of the International Headache Society New PROCEED phase 2b route of administration and dose-finding trial results of bocunebart (Lu AG09222; anti-PACAP mAb) being investigated in migraine prevention 2 DEERFIELD, Ill.--(BUSINESS WIRE)--Lundbeck US, the US subsidiaries of H. Lundbeck A/S., today announced the presentation of new VYEPTI® (eptinezumab-jjmr) data at the American Headache Society’s (AHS) 68th Annual Scientific Meeting, taking place June 4-7, 2026, in Orlando, Florida. The presentations will share findings from the INFUSE, DELIVER, SUNSET, and RESOLUTION trials, featuring real-world data and phase 3 clinical trial post-hoc analyses of VYEPTI and patient-reported outcomes on headache hours, brain fog and other cognitive symptoms, and dose escalation. New phase 2b data on bocunebart, an investigational drug targeting Pituitary Adenylate Cyclase-Activating Polypeptide (PACAP) for the prevention of migraine, will also be presented. “To truly raise the bar and optimize outcomes for migraine care, we must continue to focus on what patients report are meaningful to them,” said Damian Fiore, Vice President, US Medical Affairs, Neurology at Lundbeck. “These data reinforce the importance of looking beyond headache days to the broader burden of migraine and the sustained impact preventive treatment may have over time.” VYEPTI is indicated for the preventive treatment of migraine in adults. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of its ingredients. Reactions have included anaphylaxis and angioedema. Please see Important Safety Information below. Lundbeck VYEPTI Migraine Data at AHS Presentation Summary Presentation Number Real-world effectiveness of eptinezumab treatment on migraine-related cognitive symptoms in participants in whom ≥1 prior CGRP-targeted therapy had failed: 12-month results of the INFUSE study In the 12-month INFUSE study, patients reported a sustained improvement across multiple cognitive symptoms in participants who self-reported at least one prior CGRP-targeted therapy had failed. 1 At 12 months, participants measured changes across all cognitive symptoms evaluated, including brain fog, difficulty making decisions, reading comprehension, and complex tasks. 1 These findings underscore the importance of evaluating cognitive burden in migraine and assessing changes during preventive treatment. T 15 Reductions in Headache hours with severe pain intensity with eptinezumab treatment: Post hoc analysis of the DELIVER trial The post-hoc analysis of the 72-week DELIVER trial ( NCT04418765 ) investigated total time (in hours) spent with headache and headache hours with severe pain through 72 weeks in patients with chronic or episodic migraine and 2-4 previous preventive treatment failures. The full analysis set (N=890) was evaluated. 3 This analysis supports the concept that pain is a distinct dimension of migraine, separate from frequency. T 29 Dose escalation to eptinezumab 300 mg: A subgroup analysis of the 60-week, open-label SUNSET trial in Japanese participants with chronic migraine who experienced suboptimal response A post-hoc analysis of the 60-week extension phase of the SUNSET trial ( NCT05064371 ) evaluated dose escalation in Japanese participants (n=160) with chronic migraine who had a suboptimal response (14 days, and episodic migraine as migraine occurring on ≥4 days and headache occurring on ≤14 days. All patients had to have experienced failures of two to four prior preventive treatment classes (including: propranolol, metoprolol, topiramate, amitriptyline, flunarizine, valproate, divalproex, candesartan) or botulinum toxin A/B (if documented that botulinum toxin was used for chronic migraine), and at least one failure being due to inadequate efficacy. Patients who experienced failure on a previous treatment targeting the CGRP pathway were excluded from participation. Documented evidence of prior migraine treatment failures was supported by medical records or by physicians’ confirmation specific to each treatment in the past 10 years. About the SUNSET trial The SUNSET trial (NCT05064371) was an extension of the phase 3, multiregional, randomized, double-blind, placebo-controlled SUNRISE trial (NCT04921384) conducted in adults (18–75 years) diagnosed with chronic migraine. 159 Japanese participants who completed SUNRISE were enrolled and treated in SUNSET after completing 12-week, randomized, double-blind treatment with IV eptinezumab-jjmr 100 mg, 300 mg, or placebo. SUNSET comprised a 60-week open-label treatment period (during which participants received IV eptinezumab-jjmr every 12 weeks [5 doses total] and completed a daily electronic diary) and an 8-week safety follow-up period. All participants received eptinezumab-jjmr 100 mg at baseline in SUNSET, participants who did not achieve ≥50% reduction from SUNRISE baseline in monthly migraine days (MMDs; SUNSET Weeks 1–12) had their dose increased to 300 mg at SUNSET Week 12 and onward. The primary endpoints investigated long-term safety and tolerability, including treatment emergent adverse events (TEAEs). Secondary endpoints included change from baseline in the number of MMDs, ≥50% and ≥75% migraine responder rates (MRRs), and Patient Global Impression of Change (PGIC) score. Exploratory endpoints included change from baseline in the Migraine-specific Work Productivity and Activity Impairment (WPAI:M) questionnaire domain scores. About the RESOLUTION trial The RESOLUTION trial was a phase IV, multi-national, randomized, double-blind, placebo-controlled trial. The trial enrolled 608 participants with dual diagnoses of chronic migraine and MOH, and participants were randomly allocated to one of two treatment groups, brief educational intervention (BEI) and eptinezumab-jjmr (100 mg; n = 305) or BEI and placebo (n = 303), in a 1:1 ratio. BEI involves a short screening followed by individual feedback on how and why acute migraine medication use should be reduced, and this approach to patient education has been shown to result in long-term medication reductions for patients with MOH. RESOLUTION is the first randomized controlled trial to assess the efficacy of an anti-CGRP treatment in combination with structured patient education in chronic migraine and MOH. The primary endpoint was the change from baseline in monthly migraine days over weeks 1-4. Key secondary endpoints included change from baseline in average daily pain assessment score (as accessed by 3-point pain intensity scale, mild, medium, severe), and change from baseline in acute medication use over 1-12 weeks. Other secondary and exploratory endpoints assessed monthly migraine days over weeks 1-12, MOH remission, transition from chronic to episodic migraine, reductions in headache-related burden, migraine-related disability, work productivity loss, activity impairment, and the safety and tolerability of eptinezumab-jjmr in this patient population. The participants in the RESOLUTION trial were mainly from European countries. About bocunebart Bocunebart is an investigational monoclonal antibody (mAb) with a novel mechanism of action. It is engineered to bind to and inhibit the signaling of pituitary adenylate cyclase-activating polypeptide (PACAP), a neuropeptide implicated in migraine pathophysiology. This mechanism operates through a pathway distinct from that targeted by anti-calcitonin gene-related peptide (anti-CGRP) therapies. Bocunebart represents a potential new treatment class and could provide an alternative option for migraine prevention, offering hope to individuals severely affected by the condition. Bocunebart is an investigational drug, not approved by the US Food and Drug Administration (FDA) or any other regulatory agency, and the efficacy and safety of bocunebart have not been established. About the PROCEED trial The PROCEED trial assessed the efficacy, safety, and tolerability of bocunebart versus placebo when administered once monthly for three months. The PROCEED trial aimed to establish the optimal dose and route of administration, subcutaneous and IV, of bocunebart. In the IV part of PROCEED a total of 431 patients from 14 countries (Bulgaria, Czechia, Denmark, France, Georgia, Germany, Hungary, Lithuania, Japan, Poland, Romania, Slovakia, Spain, and the United States) were randomized. The primary efficacy endpoint was defined as the difference between bocunebart and placebo in the mean change from baseline in the number of monthly migraine days over weeks 1 to 12. The target population for this trial was defined as patients diagnosed with migraine as outlined in the International Classification of Headache Disorders Third Edition (ICHD-3) and with treatment failure of 1-4 different preventive migraine medications in the past 10 years. About Lundbeck Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments. As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology. We are committed to fighting stigma and we act to improve health equity. We strive to create long-term value for our shareholders by making positive contributions to patients, their families and society as a whole. Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. Lundbeck US comprises the wholly owned US subsidiaries of H. Lundbeck A/S (HLUNa / HLUNb, HLUNA DC / HLUNB DC) (“Lundbeck”), including Lundbeck LLC and Lundbeck Pharmaceuticals LLC. For additional information, please visit Lundbeck.com/us and connect with us on LinkedIn , Instagram , and X at @LundbeckUS . References Starling, A., Lipton, R., Soni-Brahmbhatt., et al. Real-World Impact of Eptinezumab Treatment on Migraine-Related Cognitive Symptoms in Participants in Whom ≥1 Prior CGRP-Targeted Therapy had Failed: 12-Month Results of a Prospective Study. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026. Ailani, J., Phul, R., Florea, I., et al. Targeting PACAP in migraine prevention: Outcomes from the PROCEED phase 2b trial of bocunebart (Lu AG09222). Presented at American Headache Society 68th Annual Scientific Meeting. June 2026. Tassorelli, C., Awad, S., Grossman, S., et al. Headache hours with severe pain intensity during long-term treatment with eptinezumab: Post hoc analysis of the DELIVER trial. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026. Mcallister, P., Asher, D., Awad, S., et al. Dose escalation to eptinezumab 300 mg: A subgroup analysis of the 60-week, open-label SUNSET trial in Japanese participants with chronic migraine who experienced suboptimal response. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026. Lipton, R., Terwindt, G., Jensen, R., et al. Consistent efficacy of eptinezumab across countries in adults with CM and MOH who also received patient education: Results from the RESOLUTION trial. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026. Starling, A., Ailani, J., Florea, I., et al. Safety and Tolerability of Anti-PACAP Monoclonal Antibody Lu AG09222 when Co-administered with a Gepant in Participants with Migraine. Presented at American Headache Society 68th Annual Scientific Meeting. June 2026. What is migraine? nids.nih.gov Law H. Z., Chung M. H., Nissan G., Janis J. E., Amirlak B. Hospital burden of migraine in United States adults: A 15-year national inpatient sample analysis. 2020. Lipton R. B., Buse D. C., Nahas S. J., et al. Risk factors for migraine disease progression: a narrative review for a patient-centered approach. J Neurol . 2023;270(12):5692-5710. doi:10.1007/s00415-023-11880-2 Cohen, F., Brooks, C. V., Sun, D., Buse, D. C., Reed, M. L., Fanning, K. M., & Lipton, R. B. (2024). Prevalence and burden of migraine in the United States: A systematic review. Headache , 64(5), 516–532. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the Global Burden of Disease Study 2019. Buse D. C., Scher A. I., Dodick D. W., et al. Impact of Migraine on the family: Perspectives of people with migraine and their spouse/domestic partner in the CaMEO study. Mayo Clinic . 2016, 91(5):596-611. doi: 10.1016/j.mayocp.2016.02.013 . Contacts Brittany Korb Director, Product and Portfolio Communications brkr@lundbeck.com