Optimization of the Efficacy and Safety of Nalbuphine Combined with Esketamine for Post-Cesarean Analgesia: A Randomized, Double-Blind, Parallel-Controlled Clinical Study

开始日期2025-07-01

申办/合作机构-

NCT06853041

/ Not yet recruiting临床4期IIT

Etude randomisée contrôlée en Double-aveugle ESKAPE : ESKétamine Low-dose Versus kétamine Low-dose Pour la Douleur Aiguë sévère Aux Urgences, Comparaison Des Effets PsychodyslEptiques

Almost 30% of painful patients in emergency departments (ED) describe their pain as severe (i.e. a Verbal Numerical Rating Score VNRS ≥ 6 on a scale ranging from 0 to 10). The management of such severe pain needs to be rapid and safe, and for this purpose intravenous (IV) morphine titration is still the gold-standard. However, morphine titration takes up considerable caregiver time, as patients need to be monitored and treated progressively with small quantities of morphine every 5 minutes until analgesia. This is sometimes difficult to reconcile with a saturating flow of patients, and overcrowding in ED is proven to significantly delay time-to-analgesia, and even lead to deleterious under-treatment. Finally, the opioid crisis is a major concern, explaining why strategies are being advocated to develop other ways of managing severe acute pain in the ED and to limit the use of opioids.
Recent studies show that ketamine administered in small IV doses ("low-dose" ketamine LDK: 0.2 to 0.3 mg/kg) possesses potent analgesic activity as well as interesting anti-hyperalgesic and anti-allodynic properties. Compared with morphine, LDK does not induce respiratory depression, but can sometimes induce disturbing psychodysleptic effects. These may include a sensation of unreality, fatigue, anxiety, dizziness or hallucinations. According to studies, 30-80% of LDK-treated patients experience psychodysleptic effects. However, two recent studies suggest that slow IV injections of LDK (over 10 minutes) may improve patient tolerance, although these slow infusions do not totally reduce this discomfort.
Pharmacologically, ketamine is a racemic mixture of 2 isomers: esketamine S(+), which is dextrorotatory, and arketamine R(-), which is levorotatory. In recent years, a new formulation containing only esketamine has been made available to hospitals in some northern European countries, and more recently in France. Esketamine appears to have twice the analgesic efficacy of racemic ketamine, and studies on healthy volunteers or in peri-operative settings suggest that it is also better tolerated psychologically than ketamine. For the moment, however, scientific data are lacking, and no comparative trial has yet been conducted in the ED setting. The investigators plan to conduct in their ED a prospective, single-center, randomized, double-blind study aiming to compare the tolerance and efficacy of esketamine versus racemic LDK in patients presenting with severe acute pain (VNRS ≥ 6/10).

开始日期2025-06-01

申办/合作机构

Centre Hospitalier Universitaire de Nice

NCT05603104

/ Recruiting临床3期IIT

A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

开始日期2025-04-30

申办/合作机构

University Medical Center of Utrecht

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100 项与盐酸艾司氯胺酮相关的临床结果

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100 项与盐酸艾司氯胺酮相关的转化医学

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100 项与盐酸艾司氯胺酮相关的专利（医药）

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2,336

项与盐酸艾司氯胺酮相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Respiratory depression in women receiving propofol/esketamine versus propofol/fentanyl for abortion surgery or curettage: a randomized clinical trial

Article

作者: Chen, Huihe ; Guan, Xuehai ; Luo, Jiaxin ; Wu, Xiaoshan ; Cao, Huiyu ; Lan, Hongmeng ; Lin, Yuliu ; Zhang, Cuiwen ; Liao, Yeqing ; Huang, Xiaofang

BACKGROUND:

A combination of opioids with propofol is a popular approach to non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression. We compared the incidence of esketamine- and fentanyl-induced respiratory depression in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

METHODS:

This study included 176 women (aged 18-60 years) scheduled for abortion surgery or curettage. Patients were randomized into the fentanyl or esketamine groups. Patients in the fentanyl group received fentanyl (1 µg/kg) combined with propofol intravenously. Patients in the esketamine group received subanaesthetic doses of esketamine (0.15 mg/kg) combined with propofol intravenously. The primary outcome was the incidence of respiratory depression during anaesthesia. Secondary outcomes included respiratory rate, pulse oximetry, blood pressure, heart rate, propofol dose, duration of surgery, duration of anaesthesia, and adverse events.

RESULTS:

The incidence of respiratory depression in the esketamine group was significantly lower than that in the fentanyl group (11% vs. 45%; p < .0001). Propofol administration was lower with esketamine than fentanyl. Respiratory rate, SpO₂ and blood pressure were more stable in the esketamine group than in the fentanyl group. The incidences of hypotension, propofol-induced injection pain and chin lifting in the esketamine group were lower than those in the fentanyl group. The incidence of nightmares was higher in the esketamine than in the fentanyl group.

CONCLUSIONS:

The incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.KEY MESSAGESOpioids combined with propofol is a popular method for non-intubated general anaesthesia; however, this method usually results in higher incidence of respiratory depression.At subanaesthetic doses, esketamine provides an analgesic effect by antagonizing the N-methyl-d-aspartate receptor.In this trial, the incidence of respiratory depression was lower with subanaesthetic doses of esketamine than with fentanyl in women undergoing abortion surgery or curettage under propofol-based non-intubated general anaesthesia.

2025-12-31·ANNALS OF MEDICINE

Optimal doses of intranasal esketamine plus dexmedetomidine for sedating toddlers during transthoracic echocardiography: a prospective, double-blind, randomized trial

Article

作者: Du, Zhen ; Qu, Shuangquan ; Xiao, Ting ; Zeng, Li ; Wei, Siwei ; Wang, Lei ; Pei, Dongjie

INTRODUCTION:

Esketamine has unique advantages in combination with dexmedetomidine for sedation in young children, owing to its sympathetic activity and mild respiratory depression. However, the optimal dose is yet to be determined. In this study, we compared the different doses of intranasal esketamine combined with dexmedetomidine for sedation during transthoracic echocardiography in toddlers.

PATIENTS AND METHODS:

A total of 121 eligible children aged 13 years, who were scheduled for transthoracic echocardiography were randomized into three groups. They were treated with intranasal dexmedetomidine 1 mcg.kg^-1 + esketamine 0.5 mg.kg^-1 (group S1), dexmedetomidine 1 mcg.kg^-1 + esketamine 1 mg.kg^-1 (group S2), or dexmedetomidine 1 mcg.kg^-1 + esketamine 1.5 mg.kg^-1 (group S3). The primary outcome was the success rate of sedation, other outcomes included HR, SpO₂, onset time, wake-up time, and adverse effects.

RESULTS:

The success rate of sedation was significantly higher in groups S2 (85.4%) and S3 (87.5%) than ingroup S1 (60%) (p = 0.004). The baseline HR and SpO₂ did not differ between the groups at the corresponding time points following drug administration. The onset time and duration of sedation in group S1 were significantly longer than those in groups S2 and S3 (p = 0.000). However, there were no differences in the wake-up time or adverse effects among the three groups.

CONCLUSIONS:

Intranasal administration of 1 mg.kg^-1 esketamine combined with 1 mcg.kg^-1 dexmedetomidine provided satisfactory sedation in young children undergoing transthoracic echocardiography. This sedative approach offers a rapid onset of awakening with few side effects.

CLINICAL TRIAL REGISTRATION NUMBER:

ChiCTR2200060976, 2022/06/14 (trail from August 2022 to January 2023).

2025-12-31·ANNALS OF MEDICINE

Effects of esketamine infusion on tourniquet-induced hypertension in patients undergoing below-knee orthopedic surgery: protocol for a randomized controlled trial

Article

作者: Ying, Yao-yu ; Shi, Hai-jing ; Ji, Fu-hai ; Jiang, Kai ; Peng, Ke ; Zhuang, Min-yuan ; Zhao, Wen-qian

INTRODUCTION:

Application of a tourniquet reduces surgical bleeding while causing pain and tourniquet-induced hypertension (TIH). Deeper anesthesia and additional opioids are often insufficient to mitigate TIH but are associated with prolonged recovery and complications. Herein, we describe the protocol for a clinical trial investigating whether intraoperative esketamine infusion would reduce the rate of TIH during below-knee orthopedic surgery.

PATIENTS AND METHODS:

This prospective, randomized, double-blind, controlled trial will include a total of 80 adults scheduled for below-knee orthopedic surgery under general anesthesia. Patients will be randomly assigned in a 1:1 ratio to receive either esketamine infusion at 0.25 mg/kg/h or normal saline infusion after anesthesia induction and during tourniquet inflation. Both groups will receive ultrasound-guided unilateral popliteal sciatic nerve block and adductor canal block with 0.25% ropivacaine. The primary outcome is the occurrence of TIH, defined as an increase in systolic blood pressure >30% of baseline during tourniquet inflation. Secondary outcomes include the incidence of hypotension during surgery; intraoperative hemodynamic changes; intraoperative opioid dose and total amount of esmolol; postoperative nausea and vomiting, dizziness, and mental side effects; postoperative pain at 1, 6, 12, and 48 h after surgery; postoperative analgesic consumption within 48 h after surgery; and length of postoperative hospital stay. Additionally, we will assess patients' quality of recovery at 24 h after surgery.

DISCUSSION:

This trial will determine the effects of esketamine infusion on TIH in patients who undergo below-knee orthopedic surgery under general anesthesia. Our results will offer a new insight into optimizing anesthetic care for surgical patients receiving tourniquet.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry (ChiCTR2400081237).

506

项与盐酸艾司氯胺酮相关的新闻（医药）

2025-04-13

·摩熵医药

近80亿β受体阻滞剂市场：阿斯利康、齐鲁、默克三强争霸

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。在心血管疾病治疗领域，β受体阻滞剂占据着举足轻重的地位。从2015年到2022年，我国β受体阻滞剂市场规模一路攀升，年复合增长率达9.87% ，在2022年达到峰值83.26亿元。然而，2023年受集采影响，市场规模下滑至 78.35亿元。这一市场中，109家企业角逐32个品种。阿斯利康凭借琥珀酸美托洛尔缓释片，五年累计销售额超 200 亿元；齐鲁制药、默克等药企也各展身手。不同代际的β受体阻滞剂在临床上的使用情况差异明显，第二代广泛应用，第三代崭露头角。那么，在这风云变幻的市场中，各企业和品种究竟有着怎样的竞争策略与发展态势？本文基于摩熵咨询《β受体阻滞剂市场研究专题报告》，向读者剖析β受体阻滞剂的各类产品布局、市场表现与企业竞争格局，揭示β受体阻滞剂领域的竞争逻辑与未来趋势。01β受体阻滞剂市场概览据统计，2023年β受体阻滞剂市场规模近80亿元，生产企业数量高达109家。根据摩熵医药数据库统计显示，我国β受体阻滞剂市场规模从2015年的43.09亿元上升至2022年的峰值83.26亿元，年复合增长率为9.87%，2023年整体市场规模受集采影响，下滑至78.35亿元，同比下降5.9%。品种/企业数量方面，2023年β受体阻滞剂合计品种数量达32个，生产企业数量高达109家。图片来源：摩熵医药《β受体阻滞剂市场研究专题报告》02β受体阻滞剂企业竞争格局 01阿斯利康位列企业销售排行榜首，五年累计销售额超200亿元我国β受体阻滞剂市场的领先企业为阿斯利康。根据摩熵医药数据库统计显示，2019-2023年合计销售额约201.58亿元，包括医院端销售额151.97亿元，药店端销售额49.61亿元，阿斯利康为唯一一家近五年累计销售额突破200亿元的企业。外资药企中，默克在我国β受体阻滞剂市场也占据重要市场份额，2019-2023年合计销售额约42.94亿元，展现出较强的市场竞争力。国内药企中，齐鲁制药取得不俗的销售表现，其2019-2023年合计销售额约48.50亿元，位列企业排行榜第二位。阿斯利康、齐鲁制药及默克三家企业为第一梯队，其余企业销售额较小，总体竞争格局较分散。2019-2023年β受体阻滞剂累计销售额企业排行榜02凭借核心重磅产品，第一梯队企业已建立起稳固的竞争优势阿斯利康旗下主要产品为琥珀酸美托洛尔缓释片，商品名为倍他乐克，这款产品是β受体阻滞剂第一大品种，除治疗高血压外，在心率失常、心力衰竭、心绞痛等领域也应用广泛，被誉为心脑内科用药“万金油”。默克旗下主打产品为富马酸比索洛尔片，为β受体阻滞剂类药物第二大品种，也是心血管疾病的首选药物之一。齐鲁制药旗下主要品种为盐酸艾司洛尔注射液，这款产品为β受体阻滞剂类药物第三大品种，也是治疗心动过速、主动脉夹层、围手术期高血压等的一线药物。图片来源：摩熵医药销售数据库、摩熵医药全球药物研发数据库03β受体阻滞剂品种竞争格局 01前十大品种占据76%的市场，第二代药物目前在临床上使用最广泛据摩熵医药销售数据库显示，在2023年全国医院销售额TOP10中，销售额最大的品种为琥珀酸美托洛尔缓释片，年销售额约24.98亿元，其次为盐酸艾司洛尔注射液（11.42亿元）和富马酸比索洛尔片（8.63亿元）。排名前十的品种合计销售额约59.23亿元，占2023年总销售额的75.60%。目前我国临床使用最广泛的β受体阻滞剂为第二代药物，2023年第二代β受体阻滞剂市场份额约85.13%，占据绝对主导地位。第一代已逐渐被市场淘汰，市场份额小于5%，第三代药物由于疗效更显著、安全性更佳逐渐受到市场关注，2023年其市场份额已超过10%。图片来源：摩熵医药《β受体阻滞剂市场研究专题报告》02美托/比索洛尔集采后份额下降，艾司/阿罗洛尔市场份额快速提升品种竞争格局方面，2023年市场份额排名前四的品种依次为美托洛尔（52.26%）、比索洛尔（16.18%）、艾司洛尔（16.02%）、阿罗洛尔（5.78%），历年各品种份额虽稍有波动，但整体来看，前四大品种份额次序相对稳定。β受体阻滞剂类药物中，比索洛尔首个进入第二批国采，美托洛尔口服常释剂型纳入第五批国采，缓控释剂型纳入第七批国采。集采后，美托/比索洛尔合计市场份额从2019年的81.93%降至2023年的68.44%。艾司洛尔、第三代品种阿罗洛尔市场份额则快速提升，根据摩熵医药数据库统计显示，艾司洛尔市场份额从2019年的8.09%上升至2023年的16.02%。截止2024年10月，有20家仿制药企的艾司洛尔通过/视同通过一致性评价。目前其已中选第十批国采，现有竞争格局将重塑。图片来源：摩熵医药销售数据库结语综上所述，我国β受体阻滞剂市场在过往数年经历了增长与调整。集采政策深刻影响了市场格局，美托洛尔、比索洛尔等品种市场份额下降，而艾司洛尔、阿罗洛尔等则迎来发展机遇。阿斯利康、齐鲁制药、默克等药企凭借核心产品在竞争中脱颖而出。随着医药技术的持续进步和市场环境的不断变化，未来β受体阻滞剂市场必将更加精彩。第三代药物有望凭借其优势进一步拓展市场，更多药企也可能凭借创新产品或优化策略实现突破。让我们拭目以待，共同见证这一市场的下一段发展历程。END本文为原创文章，转载请留言获取授权β受体阻滞剂市场研究专题报告下期内容预告目录一、50亿「洛尔一哥」跌落！AZ失守70%市场，齐鲁、苑东生物靠集采狂抢份额近期将持续更新，敬请期待近期热门资源获取CGT产业现状与未来趋势蓝皮书-202406中药行业现状与未来趋势白皮书-2024072023年医药企业综合实力排行榜-202408跨越国界，引领创新：中国药企出海的布局实践-202408专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409中国放射性药物市场现状分析报告-202410合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410中国合成生物学创投市场分析报告-202410中国糖尿病临床诊疗与药物多渠道市场数据分析-202411基于剂型改良的复杂注射剂分析--微球篇-2024112024医美注射材料市场发展分析报告-20241213国家药品集采跟踪报告-前9批次集采回顾与展望-202411近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

带量采购医药出海核酸药物

2025-04-11

·生物制品圈

下一个赛道来自“精分”？强生、BMS、再鼎、绿叶竞逐

精神病领域有望迎来下一个重磅药物。4月9日晚，强生宣布已完成对Intra - cellular的收购，通过此次收购，强生不仅将卢美哌隆（lumateperone）纳入囊中，还包括具有同类最优潜力的临床阶段管线，进一步丰富了其在精神健康领域的布局。据悉，此前强生豪掷146亿美元收购中枢神经系统（CNS）治疗药物的企业Intra - cellular。这一金额超过了强生自己在2024年创下的全球医药企业收购金额记录。强生天价收购Intra-cellular，主要目标就是拿下具有两大类精神疾病适应症的卢美哌隆，其销售业绩表现强劲，从2020年的2281万美元增长至2023年的4.64亿美元，2024年预计达到6.85亿美元。本次，强生对Intra-Cellular的收购，只是CNS领域蓬勃发展的一个缩影。精神类药物市场正成为全球药企新的竞争焦点，也带起了该赛道的风口，达成的收购金额呈现上涨趋势，其中Karuna是以140亿美元被BMS收购，艾伯维以87亿美元收购Cerevel 。MNC对CNS的兴趣还在延续，2025年1月渤健宣布将总估值为4.42亿美元“抄底”Sage。不过，高价押注CNS赛道能否真正带来预期的市场回报？CNS“难啃的骨头”相较于传统优势领域（如肿瘤、免疫）竞争白热化，CNS领域仍有大量未被满足的临床需求。然而CNS的药物研发领域一直被认为是医药行业的“硬骨头”，从机制不明，到动物模型难验证、临床开发难，每一项都是CNS药物开发的拦路虎。2024年11月，艾伯维宣布其收购 Cerevel的核心药物——用于治疗精神病症状急性加重的精神分裂症新药Emraclidine的两项EMPOWER临床试验失败。同年，Neumora精神分裂症治疗药物NMRA-266因临床前数据显示该药物引发了兔子的抽搐被FDA叫停试验。NMRA-266 是 M4 毒蕈碱受体的高选择性正变构调节剂；2024年9月，Neurocrine的精神分裂症药物luvadaxistat二次临床II期失败，最终决定停止开发luvadaxistat（NBI-1065844）。而在此之前，罗氏和丹麦灵北制药都曾宣布终止相关管线。接连的试验失败凸显了CNS药物研发的高风险特性，也表明这一领域的药物以及更广泛的新神经科学项目背后机制的复杂性远超预期。收购公告中，强生强调了自身在神经科学领域近70年的经验，拥有多款商业化的神经类药物，其中抗抑郁鼻腔喷雾剂Spravato在2024年销售额突破10亿美元，研管线中还有两款III期临床产品seltorexant和aticaprant。2024年Q3更新的研发管线中，强生终止了3个CNS临床研究项目，分别是seltorexant治疗阿尔茨海默病的2期临床研究、P2X7拮抗剂治疗双相障碍的2期临床研究以及JNJ-0376治疗帕金森病的I期临床研究。可见即使手握可观盈利产品的强生，也面临CNS的研发困境。2024年，强生神经科学业务营收71.15亿美元，在创新制药业务中占比仅12.5%，远低于肿瘤业务的36.48%和免疫业务的31.30%。收购Intra-Cellular不仅能助力强生在神经领域的发展，还囊括一款50亿美元的重磅炸弹。卢美哌隆2019年首次获得FDA批准，治疗精神分裂症，2021年12月又获批了双相情感障碍适应症。在这两大适应症的支撑下，卢美哌隆已经展现出了不菲的商业化潜力。2023年，其销售额已经达到4.62亿美元，同比增长86%；2024年继续增长，前三季度销售额达到4.82亿美元，预计全年最高可达6.85亿美元。值得一提的是，卢美哌隆还将继续快速增长。就在2024年底，Intra-Cellular向FDA提交了卢美哌隆的第3项新适应症上市申请，用于重度抑郁症（MDD）的辅助治疗。MDD的潜在患者人数要远多于精分和双相。根据强生披露的数据，全球超过10亿人——即每8人中就有1人患有神经精神或神经退行性疾病。而在美国，大约240万成年人患有精神分裂症，610万成年人患有双相情感障碍，2100万成年人患有MDD。因此，强生对Caplyta寄予厚望，预计其销售峰值将达到50亿美元。研发难且热情不减根据Frost & Sullivan的预测，全球神经科学药物市场规模将从2022年的1600亿美元增长到2028年的2200亿美元。尽管开发CNS药物具有较大的难度和风险，但由于市场进入壁垒高，且空间潜力巨大，仍吸引着许多药企抢滩布局。技术进步也是推动CNS领域发展的重要因素，2024年9月，BMS宣布Karuna的核心产品KarXT获美国FDA批准上市，它是数十年来首个获批的全新机制的精神分裂症治疗药物。此次批准使BMS在神经科学和精神病学领域获得了重要的立足点。值得一提的是，再鼎医药拥有KarXT大中华区市场的权益，据再鼎医药披露的信息，中国约有80万精神分裂症患者。有望于2024年到2025年上半年获得研究的关键数据，并在中国内地提交KarXT用于精神分裂症的新药上市申请。据悉，除了治疗精神分裂症以外，KarXT目前正在进行注册临床试验，评估治疗阿尔茨海默病精神病的效果，预计2026年获得数据。此外，BMS认为KarXT在其他适应症方面也具有潜力，包括I型双相情感障碍和阿尔茨海默病躁动症。有分析师估计，BMS的KarXT已进入FDA的精神分裂症治疗程序，其销售额可能高达60亿美元。在KarXT身后，全球已进入临床Ⅲ期或注册申请阶段的抗精神分裂症药物已有9款，包括三菱制药的roluperidone、丹麦灵北制药与恩华药业的Lu AF35700、SyneuRx的苯甲酸钠、Newron的依文酰胺、勃林格殷格翰的iclepertin等。此外，国内药企绿叶制药自研的瑞可妥（Rykindo）是一种利培酮微球产品，分别于2021年、2023年在中国、美国获批上市，用于治疗精神分裂症和双相情感障碍，是首个由中国药企自主研发并在美获批的中枢神经系统新药。在CNS领域，绿叶制药还有数款已上市产品或在研管线，彰显出极为强劲的竞争力。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观不本站。

并购临床2期临床3期

2025-03-31

·GlobeNewswire-Health Care

Evernorth Health Services, a Cigna Company, Expands NeuroStar® TMS Coverage for Adolescents Struggling with Depression

Policy update increases access for millions covered by Evernorth Health ServicesMALVERN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a vertically integrated, commercial stage, medical technology and healthcare company with a strategic vision of transforming the lives of patients whenever and wherever they need help, with the leading neurohealth therapies in the world, announced that Evernorth Health Services, a wholly owned subsidiary of The Cigna Group, has expanded its coverage of NeuroStar® Transcranial Magnetic Stimulation (TMS) to include adolescents aged 15 and older living with major depressive disorder (MDD). As these health policies cover 15 million lives, the expansion greatly improves access to non-drug treatment options for adolescent patients who are seeking non-drug options for depression. The expansion is effective immediately, nearly one year after NeuroStar® Advanced Therapy received FDA clearance as the first first-line add-on treatment for adolescents aged 15-21 with MDD. In the past year, several leading insurers have rapidly updated their policies to reflect the FDA clearance, including but not limited to Humana, Aetna, Medi-Cal, BCBS-HCSC, Pacific Source, and more. “This decision by Cigna/Evernorth is a significant step forward for adolescent mental healthcare and reflects the momentum we have built with payors over the past year since NeuroStar first received the FDA clearance for adolescents,” said Keith J. Sullivan, President and CEO of Neuronetics. “We are grateful that millions more families will now have easier access to NeuroStar TMS as a proven, non-drug treatment for major depression and can get the care they deserve.” An estimated 4.3 million U.S. adolescents aged 15-21 are affected by major depression1. Depression amongst adolescents can disrupt crucial aspects of development, such as academic performance, relationships with peers and family members, and overall emotional well-being. With limited medication options for adolescents with MDD, NeuroStar is a safe and effective option that can be used as a first-line add-on with robust clinical outcomes. “NeuroStar stands as the leading TMS device, backed by the most comprehensive data that clearly demonstrates its effectiveness in treating adolescent major depressive disorder,” said Geoffrey Grammer, MD, Chief Medical Officer of Neuronetics. “At Neuronetics, we are deeply committed to putting patients first, advancing clinical research, and ensuring that those in need have access to life-changing, innovative solutions.” Neuronetics is the only TMS company in the industry with a dedicated health policy team that partners with both providers and payors to advocate for health policy updates. For more information about NeuroStar Advanced Therapy, please visit www.neurostar.com. About Neuronetics Neuronetics, Inc. believes that mental health is as important as physical health. As a global leader in neuroscience, Neuronetics is delivering more treatment options to patients and physicians by offering exceptional in-office treatments that produce extraordinary results. NeuroStar Advanced Therapy is a non-drug, noninvasive treatment that can improve the quality of life for people suffering from neurohealth conditions when traditional medication has not helped. In addition to selling the NeuroStar Advanced Therapy System and associated treatment sessions to customers, Neuronetics operates Greenbrook TMS Inc. (Greenbrook) treatment centers across the United States, offering NeuroStar Advanced Therapy for the treatment of MDD and other mental health disorders. NeuroStar Advanced Therapy is the leading TMS treatment for MDD in adults, with more than 7.1 million treatments delivered, and is backed by the largest clinical data set of any TMS treatment system for depression, including the world’s largest depression outcomes database. Greenbrook treatment centers also offer SPRAVATO® (esketamine) Nasal Spray, a prescription medicine indicated for the treatment of treatment-resistant depression (TRD) in adults as monotherapy or in conjunction with an oral antidepressant. It is also indicated for depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior in conjunction with an oral antidepressant.1 Greenbrook has provided more than 1.68 million treatments to over 51,000 patients struggling with depression. The NeuroStar Advanced Therapy System is cleared by the U.S. Food and Drug Administration for adults with MDD, as an adjunct for adults with obsessive-compulsive disorder, to decrease anxiety symptoms in adult patients with MDD that may exhibit comorbid anxiety symptoms (anxious depression), and as a first line adjunct for the treatment of MDD in adolescent patients aged 15-21. For safety information and indications for use, visit NeuroStar.com. Neuronetics Contact:Investors:Mike Vallie or Mark KlausnerICR Healthcare443-213-0499ir@neuronetics.com Media:EvolveMKD646.517.4220NeuroStar@evolvemkd.com References World Health Organization, Depression Fact Sheet. Accessed April 29, 2024. https://www-who-int.libproxy1.nus.edu.sg/news-room/fact-sheets/detail/depression. ________________________________* The effectiveness of SPRAVATO® in preventing suicide or in reducing suicidal ideation or behavior has not been demonstrated. Use of SPRAVATO® does not preclude the need for hospitalization if clinically warranted, even if patients experience improvement after an initial dose of SPRAVATO®. For more important safety information about SPRAVATO®, please visit spravatohcp.com.

上市批准

100 项与盐酸艾司氯胺酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10627	盐酸艾司氯胺酮	N01AX14 N06AX27	DB11823

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
抑郁症	中国	Janssen-Cilag International NV	2023-04-17
中度重度抑郁症	澳大利亚	Janssen-Cilag Pty Ltd.	2021-03-09
重度抑郁症	欧盟	Janssen-Cilag International NV	2019-12-18
重度抑郁症	冰岛	Janssen-Cilag International NV	2019-12-18
重度抑郁症	列支敦士登	Janssen-Cilag International NV	2019-12-18
重度抑郁症	挪威	Janssen-Cilag International NV	2019-12-18
麻醉	中国	江苏恒瑞医药股份有限公司	2019-11-18
难治性抑郁症	美国	Janssen Pharmaceuticals, Inc.	2019-03-05
疼痛	德国	Pfizer Inc.	1997-08-01

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
自杀意念	临床3期	美国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	保加利亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	爱沙尼亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	德国	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	匈牙利	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	马来西亚	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	斯洛伐克	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	南非	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	西班牙	Janssen Research & Development LLC	2017-06-09
自杀意念	临床3期	中国台湾	Janssen Research & Development LLC	2017-06-09

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05464979 (Pubmed \| Sci Rep)	临床4期	-	80	Esketamine	窪選選蓋簾獵選獵艱選(齋膚夢壓鏇醖窪製願窪) = 網觸範廠選簾鬱繭顧繭鑰築觸糧餘餘窪齋鏇醖 (憲淵簾製範艱築觸蓋廠, 4.0 ~ 16.3)	积极	2025-02-19
				Midazolam/sufentanil admixture	窪選選蓋簾獵選獵艱選(齋膚夢壓鏇醖窪製願窪) = 襯選鏇齋簾簾鑰鑰構繭鑰築觸糧餘餘窪齋鏇醖 (憲淵簾製範艱築觸蓋廠, 8.0 ~ 26.0)
ChiCTR2400087873 (Pubmed \| BMC Anesthesiol)	N/A	-	90	Intranasal Dexmedetomidine	遞窪鏇構網選齋獵衊壓(鏇鏇鏇積願願簾鹹廠製) = bradycardia, hypotension, hypoxia, emergence delirium etc. 繭觸遞鏇餘獵憲鏇顧餘 (壓廠製遞網蓋願膚鹽淵 )	积极	2025-02-11
				Intranasal Dexmedetomidine-Esketamine
ChiCTR2300069632 (Pubmed) 人工标引	N/A	疼痛	135	esketamine	顧膚顧鏇鹽窪鑰廠積廠(獵膚遞餘襯製製願齋鹽): P-Value = P<0.05 更多	积极	2025-01-20
				sufentanil
NCT04599855 (FDA_CDER) 人工标引	临床4期	难治性抑郁症	-	SPRAVATO (56 mg)	遞艱選構鹹繭糧築選鹽(齋獵齋鏇糧鏇艱廠蓋鏇) = 蓋餘廠齋繭製憲淵築齋壓鹹齋壓構積蓋鑰觸範 (鬱願鏇鏇壓簾積範網簾, 1.2)	积极	2025-01-17
				SPRAVATO (84 mg)	遞艱選構鹹繭糧築選鹽(齋獵齋鏇糧鏇艱廠蓋鏇) = 窪獵廠鹹鑰憲蓋醖顧製壓鹹齋壓構積蓋鑰觸範 (鬱願鏇鏇壓簾積範網簾, 1.2)
NCT03097133 \| NCT03039192 (FDA_CDER) 人工标引	临床3期	重度抑郁症	-	SPRAVATO 84 mg +SOC (NCT03039192)	壓膚範艱夢艱廠鹽網糧(壓鏇憲構廠選艱憲遞築) = 積襯積餘築網憲窪醖選醖鹹衊醖壓餘夢衊遞鏇 (積範築鹹蓋構壓鏇鏇網, 1.04)	积极	2025-01-17
				Placebo nasal spray + SOC (NCT03039192)	壓膚範艱夢艱廠鹽網糧(壓鏇憲構廠選艱憲遞築) = 網窪觸醖繭選鑰選餘蓋醖鹹衊醖壓餘夢衊遞鏇 (積範築鹹蓋構壓鏇鏇網, 1.02)
NCT06398834 (Pubmed \| Int J Clin Pharm)	临床4期	-	181	Esketamine + Butorphanol	夢願繭糧餘憲網鬱構遞(鹹鹽鑰簾廠遞構鹽糧醖) = 願選遞鬱壓窪鑰壓廠鹹夢襯鏇觸餘糧餘獵廠築 (夢顧淵襯獵選淵廠鏇鬱 )	积极	2025-01-03
				Butorphanol	夢願繭糧餘憲網鬱構遞(鹹鹽鑰簾廠遞構鹽糧醖) = 簾築築選壓選鬱夢衊網夢襯鏇觸餘糧餘獵廠築 (夢顧淵襯獵選淵廠鏇鬱 )
NCT03373253 \| NCT02497287 (ICEBERG, Pubmed \| Front Psychiatry)	临床3期	功能障碍	696	Esketamine nasal spray + SSRI/SNRI	繭選鹽夢簾鬱鏇構醖製(鬱選簾襯夢餘壓顧觸願) = 襯窪糧夢遞廠鏇簾艱鬱夢積蓋製襯積艱廠醖獵 (網簾夢餘願淵淵鏇獵膚, 21.8 ~ 29.4)	积极	2024-10-07
				esketamine nasal spray (Real-world treatment (RWT))	繭選鹽夢簾鬱鏇構醖製(鬱選簾襯夢餘壓顧觸願) = 遞網蓋襯淵鹽鹽夢顧鬱夢積蓋製襯積艱廠醖獵 (網簾夢餘願淵淵鏇獵膚, 6.9 ~ 16.1)
ChiCTR2200061956 (not available, Pubmed \| BMC Anesthesiol)	临床4期	髋部骨折 brain-derived neurotrophic factor (BDNF) \| 5-hydroxytryptamine (5-HT)	90	Esketamine	淵淵夢選淵襯簾齋積醖(鹽糧衊範範願艱簾襯齋) = 齋鹽窪糧選衊獵鏇繭鑰鹹鬱窪襯遞憲簾糧餘夢 (觸網餘構顧築廠遞鑰範 ) 更多	积极	2024-09-28
				Saline	淵淵夢選淵襯簾齋積醖(鹽糧衊範範願艱簾襯齋) = 糧網蓋鬱鬱獵積淵醖醖鹹鬱窪襯遞憲簾糧餘夢 (觸網餘構顧築廠遞鑰範 ) 更多
NCT04757675 (Pubmed \| Transl Pediatr)	早期临床1期	斜视	-	Intranasal esketamine 2 mg/kg	齋鹽夢觸製衊襯壓淵糧(醖膚選壓鑰醖窪構膚壓) = More gastrointestinal events were observed in Group K (P<0.001) 構願網範積衊製網遞築 (鑰顧夢獵觸製鑰願觸繭 )	不佳	2024-08-01
				Intranasal esketamine 1 mg/kg and dexmedetomidine 1 µg/kg
ChiCTR2100054199 (Pubmed \| JAMA Netw Open)	早期临床1期	产后抑郁症	298	Esketamine	醖壓構構壓襯襯範觸簾(糧繭鑰憲餘襯襯衊網鹹) = 簾憲襯襯膚範繭網遞醖醖顧獵鹹憲淵窪淵選鬱 (壓齋製齋餘顧齋糧鑰觸 )	积极	2024-03-06
				Control (Saline)	醖壓構構壓襯襯範觸簾(糧繭鑰憲餘襯襯衊網鹹) = 膚淵鬱衊襯鑰鏇遞選鑰醖顧獵鹹憲淵窪淵選鬱 (壓齋製齋餘顧齋糧鑰觸 )