Mirogabalin Besilate

The increasing cases of peripheral neuropathic pain, rise in screening for diabetic neuropathic pain among diabetics, increase in the geriatric population, and launch of new approved drugs, among other reasons are likely to fuel the growth of the peripheral neuropathic pain market size during the forecast period (2024–2034). LAS VEGAS, Aug. 28, 2024 /PRNewswire/ --DelveInsight's Peripheral Neuropathic Pain Market Insights report includes a comprehensive understanding of current treatment practices, peripheral neuropathic pain emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Peripheral Neuropathic Pain Market Report According to DelveInsight's analysis, the market size for peripheral neuropathic pain was found to be ~ USD 12 billion in the 7MM in 2023. The United States accounts for the largest market size of PNP in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. The total cases of peripheral neuropathic pain in the 7MM were approximately 60 million cases in 2023, which are expected to increase during the study period (2020–2034). Leading peripheral neuropathic pain companies such as Lexicon Pharmaceuticals, Merz Therapeutics, Apurano Pharmaceuticals, Vertex Pharmaceuticals, WEX Pharmaceuticals, Scilex Holding Company, and others are developing novel peripheral neuropathic pain drugs that can be available in the peripheral neuropathic pain market in the coming years. The promising peripheral neuropathic pain therapies in the pipeline include LX9211, XEOMIN (incobotulinumtoxinA), Adezunap (AP707), Suzetrigine (VX-548), HALNEURON (Tetrodotoxin or TTX), SEMDEXA (SP-102), and others. Compared to all the emerging therapies, LX9211 and SEMDEXA are expected to become the market leader, having a major influence on the peripheral neuropathic pain market of the 7MM by 2034. In November 2023, Lexicon Pharmaceuticals announced that it has enrolled the first patient in PROGRESS (A Phase IIb, dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension in patients with diabetic peripheral neuropathic pain) studying LX9211. Discover which therapies are expected to grab the major peripheral neuropathic pain market share @ Peripheral Neuropathic Pain Market Report Peripheral Neuropathic Pain Overview Peripheral neuropathies refer to conditions affecting peripheral nerve cells and fibers, arising from a variety of underlying causes. These nerves include the cranial nerves, spinal nerve roots and ganglia, nerve trunks and divisions, and the autonomic nervous system nerves. Peripheral neuropathies can be classified in several ways, such as mononeuropathies, multifocal neuropathies, and polyneuropathies. Mononeuropathy involves damage to a single nerve, while multiple mononeuropathy affects two or more nerves in different locations. Polyneuropathy typically impacts many or most nerves. The diversity of symptoms associated with peripheral neuropathy allows for the identification of distinct clinical phenotypes, which is important for guiding the diagnostic process. Nerve conduction studies are crucial for determining the phenotype and assessing severity. Additional diagnostic tools, such as laboratory tests, genetic testing, cerebrospinal fluid examination, nerve imaging, and nerve biopsy, may be useful in specific clinical situations. Peripheral Neuropathic Pain Epidemiology Segmentation The peripheral neuropathic pain epidemiology section provides insights into the historical and current peripheral neuropathic pain patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The peripheral neuropathic pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of PNP Type-specific Cases of PNP Treated Cases of PNP Peripheral Neuropathic Pain Treatment Market The treatment of peripheral neuropathic pain depends on the underlying cause and the severity of symptoms. Initial management typically involves conservative measures, including medications such as NSAIDs, acetaminophen, and, in more severe cases, opioids. For radicular symptoms, neuroleptic agents may be used, and systemic steroids are sometimes prescribed for acute low back pain. Nonpharmacological treatments like physical therapy, acupuncture, chiropractic manipulation, and traction are also employed, though their effectiveness is debated. Interventional procedures, such as epidural steroid injections and percutaneous disc decompression, are commonly performed, while surgical options like decompression and spinal fusion are considered for cases that do not respond to other treatments. Pain management for PNP also includes the use of drugs such as NSAIDs, anticonvulsants, and antidepressants, with specific medications like QUTENZA, NUCYNTA ER, and TARLIGE approved for certain patient groups. TARLIGE (mirogabalin besylate) is an oral gabapentinoid developed by Daiichi Sankyo to treat peripheral neuropathic pain (PNP), including diabetic PNP and postherpetic neuralgia. In January 2019, Daiichi Sankyo announced that TARLIGE received approval for marketing in Japan for PNP treatment, offering patients in Japan a new therapeutic option for managing PNP. NUCYNTA ER (tapentadol) is an opioid agonist available as an extended-release film-coated tablet for oral use. It is prescribed for managing neuropathic pain related to diabetic peripheral neuropathy (DPN). In August 2012, the US FDA approved a sNDA for NUCYNTA ER, allowing it to be used as an oral analgesic taken twice daily to manage neuropathic pain in adults with DPN when ongoing, around-the-clock opioid treatment is required for a prolonged duration. The QUTENZA (capsaicin) 8% topical system delivers capsaicin through a localized dermal application. Capsaicin acts as an agonist for the TRPV1 receptor. In July 2020, Grünenthal's US subsidiary, Averitas Pharma, obtained FDA approval for the QUTENZA 8% patch to treat neuropathic pain related to diabetic peripheral neuropathy in the feet of adults. To know more about peripheral neuropathic pain treatment guidelines, visit @ Peripheral Neuropathic Pain Management Peripheral Neuropathic Pain Pipeline Therapies and Key Companies LX9211: Lexicon Pharmaceuticals XEOMIN (IncobotulinumtoxinA): Merz Therapeutics Adezunap (AP707): Apurano Pharmaceuticals Suzetrigine (VX-548): Vertex Pharmaceuticals HALNEURON (Tetrodotoxin or TTX): WEX Pharmaceuticals SEMDEXA (SP-102): Scilex Holding Company Discover more about peripheral neuropathic pain drugs in development @ Peripheral Neuropathic Pain Clinical Trials Peripheral Neuropathic Pain Market Dynamics The peripheral neuropathic pain market dynamics are expected to change in the coming years. Emerging disease-modifying therapies for diabetic neuropathy, CIPN, and LSR are gaining attention due to the growing prevalence of cancer, increased chemotherapy usage, and the large patient pool in need of pain management. The lack of disease-modifying treatment options in the current landscape, which relies solely on symptomatic relief, highlights the market potential for these therapies. Recent developmental activities targeting novel pathways, such as adapter-associated kinase 1 (AAK1) and the Nav1.8 voltage-gated sodium channel, aim to provide opioid-free pain relief, which could lead to a high uptake and the ability to charge a premium price. Furthermore, potential therapies are being investigated for the treatment of peripheral neuropathic pain, and it is safe to predict that the treatment space will significantly impact the peripheral neuropathic pain market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the peripheral neuropathic pain market in the 7MM. However several factors may impede the growth of the peripheral neuropathic pain market. The management of DPN is challenging due to the persistent and severe nature of neuropathic pain, which is frequently ineffectively treated and negatively impacts the quality of life, further complicated by pharmacogenetic and genetic variations in patients; additionally, while improving glycemic control in Type-2 diabetes remains uncertain, the availability of low-cost generics in the treatment landscape may significantly hamper the uptake of emerging therapies, increasing the burden and associated health costs. Moreover, peripheral neuropathic pain treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, peripheral neuropathic pain market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact peripheral neuropathic pain market growth. Scope of the Peripheral Neuropathic Pain Market Report Therapeutic Assessment: Peripheral Neuropathic Pain current marketed and emerging therapies Peripheral Neuropathic Pain Market Dynamics: Key Market Forecast Assumptions of Emerging Peripheral Neuropathic Pain Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Peripheral Neuropathic Pain Market Access and Reimbursement Download the report to understand which factors are driving peripheral neuropathic pain market trends @ Peripheral Neuropathic Pain Market Trends Table of Contents Related Reports Peripheral Neuropathic Pain Epidemiology Forecast Peripheral Neuropathic Pain Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Peripheral Neuropathic Pain epidemiology trends. Peripheral Neuropathic Pain Pipeline Peripheral Neuropathic Pain Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Peripheral Neuropathic Pain companies, including Haisco Pharmaceutical Group, GlaxoSmithKline, Algiax Pharmaceuticals, Apurano Pharmaceuticals GmbH, Eli Lilly and Company, Shanghai SIMR Biotechnology, Lexicon Pharmaceuticals, among others. Diabetic Neuropathy Market Diabetic Neuropathy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic neuropathy companies, including Novo Nordisk, Ionis Pharmaceuticals, Pfizer, Regeneron, NeuroMetrix, among others. Diabetic Neuropathy Pipeline Diabetic Neuropathy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic neuropathy companies, including Goldfinch Bio, Novartis, Serodus, CURACLE, Daiichi Sankyo, NeuroBo Pharmaceuticals, Dong-A Pharmaceutical , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

药械追踪 No.1 / 中国首个！信达生物KRAS G12C抑制剂达伯特获批 2024年8月21日，信达生物（1801.HK）宣布，达伯特（氟泽雷塞片）获中国国家药品监督管理局（NMPA）批准上市，用于至少接受过一种系统性治疗的KRAS G12C突变型的晚期非小细胞肺癌（NSCLC）成人患者。 氟泽雷塞是一款高效口服KRAS G12C小分子抑制剂，也是中国首个获批的KRAS G12C抑制剂。氟泽雷塞通过共价不可逆修饰KRAS G12C蛋白突变体半胱氨酸残基，抑制该蛋白介导的GTP/GDP交换从而下调KRAS蛋白活化水平，进而抑制下游信号传导通路，诱导肿瘤细胞凋亡及细胞周期阻滞，达到抗肿瘤效果。 氟泽雷塞本次获批是基于一项在中国开展的临床II期单臂注册研究（NCT05005234）结果。该研究旨在评估氟泽雷塞单药在标准治疗失败或不耐受且携带KRAS G12C突变的晚期非小细胞肺癌受试者中的安全性、耐受性和疗效。结果显示，氟泽雷塞总体耐受性良好。截至2023年12月13日，共有116例NSCLC受试者纳入分析。独立影像学评审委员会（IRRC）评估的确认的客观缓解率（cORR）达49.1%；疾病控制率（DCR）达90.5%。中位缓解持续时间（DoR）未达到。中位无进展生存期（PFS）9.7个月，中位生存期（OS）尚未达到。 ->点击阅读原文，解锁完整双语新闻 No.2 / 第一三共DPNP治疗药德力静商业上市，将冲刺今年医保目录 近日，第一三共旗下用于治疗糖尿病性周围神经病理性疼痛 （DPNP）的德力静（苯磺酸美洛加巴林片）正式商业上市。 德力静是第一三共研制的第三代钙离子通道调节剂，2024年7月5日获国家药监局批准，打破了中国长期以来DPNP无药可用的治疗困境。德力静上市会上，第一三共高管表示，将紧密与医院、专业学会等之间的合作，加速这一创新疗法落地，助推DPNP的规范化管理。未来将会有更多医学举措以提升患者对DPNP的自我认知和自我管理，推动全国各地在DPNP治疗方面的多学科讨论。 德力静还将冲刺今年的国家医保药物目录，希望以更合理的价格减轻患者的疾病负担，提升药物的可及性与可支付性。 ->点击阅读原文，解锁完整双语新闻 No.3 / 国内首个！齐鲁制药雷珠单抗生物类似药在华获批上市 近日，齐鲁制药生物类似药雷珠单抗注射液（商品名：安卓明）获国家药监局上市批准，成为国内首个成功获批的雷珠单抗生物类似药。 雷珠单抗由诺华原研，是重组抗VEGF（血管内皮生长因子）人源化单克隆抗体Fab片段，靶向抑制人血管内皮生长因子A（VEGF-A），为全球首个获批用于眼科的抗VEGF药物。 此次获批上市的安卓明适用于成人，用于治疗湿性（新生血管性）年龄相关性黄斑变性（AMD）、糖尿病性黄斑水肿（DME）引起的视力损害、糖尿病视网膜病变（DR）[增殖性糖尿病视网膜病变（PDR）和中重度至重度非增殖性糖尿病视网膜病变（NPDR）]、继发于视网膜静脉阻塞（RVO) [视网膜分支静脉阻塞（BRVO）或视网膜中央静脉阻塞（CRVO) ]的黄斑水肿引起的视力损害、脉络膜新生血管[CNV，即继发于病理性近视（PM）和其他原因的CNV]导致的视力损害。此外，安卓明适用于早产儿，用于治疗Ⅰ区（1+、2+、3或3+期）、Ⅱ区（3+期）早产儿视网膜病变（ROP）或AP-ROP（急进性后部 ROP）。 安卓明Ⅲ期临床研究是一项国际、多中心、随机双盲、平行两组、阳性对照、Ⅲ期临床研究，共纳入全球11个国家97家研究中心的616例受试者，旨在比较安卓明和原研雷珠单抗注射液在受试者中的疗效和安全性。最终，基于主要终点，第8周时安卓明组和原研产品组患者BCVA字母数较基线的变化相当，在临床疗效方面具有生物等效性。 ->点击阅读原文，解锁完整双语新闻 No.4 / 康方生物依达方进入《Ⅳ期原发性肺癌中国治疗指南（2024版）》一类推荐 近日，康方生物（9926.HK）全球首创PD-1/VEGF双抗新药依达方（通用名：依沃西单抗注射液）联合化疗用于表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）治疗后广泛进展的非鳞NSCLC（nsq-NSCLC）被写入《Ⅳ期原发性肺癌中国治疗指南（2024版）》一类推荐。 依沃西单抗是康方生物独立开发的一款潜在全球首创（first-in-class）双特异性抗体，可同时阻断PD-1和VEGF通路，发挥免疫效应和抗血管生成效应。 2022年12月，康方生物与Summit达成协议，授予后者依沃西单抗于美国、加拿大、欧洲和日本的开发和商业化独家许可，总交易金额最高可达50亿美元。2024年5月，依达方在中国获批上市，用于治疗联合化疗治疗经EGFR-TKI治疗后进展的EGFR突变局部晚期或转移性非鳞状NSCLC。 ->点击阅读原文，解锁完整双语新闻 企业动态 No.1 / 金赛药业与互创联合达成辅助生殖产品商业化合作 2024年8月，金赛药业子公司金妍迪科与中国辅助生殖信息化领域著名企业武汉互创联合科技有限公司（简称“互创联合”）达成战略合作，取得互创联合商业化产品组合在中国部分区域市场的独家商业化权利，实现辅助生殖药物、软硬件及耗材全品类的布局。双方还将携手共同开拓海外市场。 此前，金妍迪科已与多家企业达成合作。 2024年4月，金妍迪科与江苏联环药业股份有限公司（简称“江苏联环”）达成产品合作，取得达那唑栓在中国大陆指定区域的商业化权利。 在妇科器械领域，2024年5月，金妍迪科与中国宫腔镜领域著名企业湖南科迈森医疗科技有限公司（简称“科迈森”）达成全球商业化合作，取得科迈森宫腹腔镜产品组合在中国部分区域及海外市场的独家商业化权利，以及一次性子宫支架在大中华区（个别指定区域除外）的独家商业化权利。 2024年7月，金妍迪科与北京斯利安药业有限公司（简称“斯利安”）达成产品合作，取得氯喹那多-普罗雌烯阴道片在中国大陆指定区域的商业化权利。 未来，金赛药业将围绕女性诊疗需求，着力将金妍迪科打造成为在辅助生殖和妇科领域领先的生物医药企业。 ->点击阅读原文，解锁完整双语新闻 行业政策 No.1 / 卫健委发布短缺药保供稳价近期工作 近日，卫健委发布《短缺药品保供稳价近期工作》，明确加强药品供求监测研判分析，集聚药物政策合力，由国家医保局持续监测国家短缺药品清单和临床必需易短缺药品重点监测清单药品的价格和配送情况。 国家卫健委指导各地健全区域医疗机构储备合作互助机制，推进信息互通和资源共享。 ▶工信部关注并跟进短缺药品制剂及原料药生产情况，完善中央和地方两级常态短缺药品储备，会同国家卫健委及时调配国家医药储备，全力保障患者救治需要。 ▶商务部密切关注药品市场供需形势，持续开展药品市场监测。 ▶国家药监局加快国家短缺药品清单品种审评审批。 ▶国家邮政局持续推动邮政综合服务平台建设，支持邮政企业拓展医邮合作。 ▶市场监管总局持续开展医药等民生领域反垄断执法专项行动和价监竞争守护行动。 ▶医保局针对部分药品价格异常上涨问题，约谈相关企业及时纠正异常高价。 ▶税务总局对分析研判发现的医药行业涉税高风险企业依法开展检查，严厉打击医药企业虚开增值税发票等违法行为。 ->点击阅读原文，解锁完整双语新闻 No.2 / 国务院发布完善市场准入制度意见 2024年8月21日，中共中央办公厅、国务院发布《关于完善市场准入制度的意见》，由法律、行政法规、国务院决定、地方性法规设定的市场准入管理措施，省、自治区、直辖市政府规章依法设定的临时性市场准入管理措施，全部列入全国统一的市场准入负面清单。 各类按要求编制的全国层面准入类清单目录和产业政策、投资政策、环境政策、国土空间规划等涉及市场准入的，全部纳入市场准入负面清单管理，各类经营主体可依法平等进入清单之外的领域。 优化新业态新领域，如生命健康、人工智能、生物医药等的市场准入环境，推动重点企业、研究机构等创新单元和有关地方建立相关领域全球前沿科学研究协同模式，积极参与国际市场准入规则和标准制定，推动重点领域创新成果便捷高效应用。围绕战略性新兴产业、未来产业重点领域和重大生产力布局，选择重点地区开展放宽市场准入试点，分批制定和推出放宽市场准入特别措施。 ->点击阅读原文，解锁完整双语新闻 全球医疗情报领导者 解锁隐藏在数据中的商业潜力  关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。 联系我们 投稿 | 发稿 | 媒体合作 ▶ zhangxinyue13@baidu.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写 点击阅读原文，解锁完整双语新闻