Nefopam Hydrochloride

MAXONA is Developing MAX-001 as a Non-Opioid, Non-NSAID Solid Oral Prescription Therapy for the Treatment of Acute and Chronic Pain and Potential Additional Indications MAX-001 is a Proprietary Optimized Extended Release Form of Nefopam Nefopam is a New Molecular Entity (NME) in the U.S. with a Well Documented Safety and Efficacy Profile in Treating Acute and Chronic Pain based on Extensive History of Use in the U.K., France, and Many other Parts of the World MALVERN, Pa., July 15, 2026 /PRNewswire/ -- MAXONA Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate MAX-001, the Company's lead compound, in the treatment of acute pain. "The FDA clearance of our MAX-001 IND is an important next step towards MAXONA'S goal of providing additional safe and effective non-opioid options for patients in the U.S. who suffer from acute and chronic pain," said Shawn Fatholahi, President & CEO of MAXONA Pharmaceuticals. "We are grateful to the FDA for their guidance and positive response to our IND submission and look forward to working with the Agency on the full development program for MAX-001." MAXONA Pharmaceuticals is developing MAX-001 as a New Molecular Entity (NME), non-opioid, oral therapy for the treatment of acute and chronic pain while also exploring additional indications. The active ingredient in MAX-001 is nefopam, which has been studied extensively and widely prescribed as an analgesic outside the U.S. in intravenous and oral dosage forms. Nefopam is a triple neurotransmitter re-uptake inhibitor delivering a potency of effect greatest on norepinephrine, then serotonin, and least on dopamine. MAX-001 is a proprietary optimized extended release (ER) solid oral formulation of nefopam and is designed specifically to deliver both a rapid onset and extended duration of analgesia. When authorized for use in the U.S., MAX-001 would be the only triple monoamine re-uptake inhibitor with an indication for the treatment of acute pain. "In the U.S, the non-opioid treatment of pain remains an area of substantial unmet medical need," said Roy Freeman, MD, Professor of Neurology and Director, Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, and Senior Medical Advisor, MAXONA Pharmaceuticals. "Nefopam was introduced outside the U.S. for the treatment of pain more than 40 years ago and has been studied in hundreds of global clinical trials which have supported the safety and efficacy of the drug. The ongoing clinical development program for MAX-001 will provide new randomized, controlled, acute post-surgical pain data while fully evaluating the potential of MAX-001 to address the urgent need for non-opioid drugs that can provide rapid, sustained analgesia with few adverse effects." "MAXONA has already completed the MAX-001-101 Phase 1 clinical trial which demonstrated that the MAX-001 proprietary optimized formulation had dose-proportional pharmacokinetics and was safe and well tolerated, "said Robert Rubens, MD, MBA, FAAN, and Clinical Development lead for MAXONA Pharmaceuticals. "There were no reported serious adverse events, premature discontinuations due to related adverse events, or severe adverse events. There were no concerning findings or abnormal trends in clinical labs, ECGs, and vital signs." With the FDA clearance in place, MAXONA will now rapidly advance the MAX-001-201 randomized, controlled Phase 2 clinical trial which will be conducted in the U.S. MAXONA expects to enroll the first patients within the next few months and complete the dosing phase of this study very quickly. About MAXONA Pharmaceuticals MAXONA Pharmaceuticals, headquartered in Malvern, PA, is a privately held clinical-stage pharmaceutical company committed to developing the next generation of therapies to help patients maximize life. The Company is distinguished by its strong leadership team with expertise in neuroscience, drug development, drug formulation and delivery technology, and pharmacology to develop patient-centric therapies that are safe, efficacious, clinically proven and trusted by physicians and their patients. The Company's initial focus is on advancing MAX-001 as a safe and highly effective non-opioid treatment of acute and chronic pain. For more information, please visit . Cautionary Statement Regarding Forward Looking Statements This release includes forward looking statements. All statements contained herein other than statements of historical facts are forward-looking statements. The words "anticipate," "believe," "continue," "estimate," "expect," "intend," "may," "will," "completes" and similar expressions are intended to identify forward-looking statements. These forward-looking statements, including regulatory timelines, are subject to a number of risks, uncertainties, and assumptions. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. We cannot guarantee future results, levels of activity, performance, achievements or events and circumstances reflected in the forward-looking statements will occur. We are under no duty to update any of these forward-looking statements after the date of this release to conform these statements to actual results or revised expectations, except as required by law. Nothing in this release should be regarded as a representation by any person that these goals will be achieved. Dr. Roy Freeman is a paid consultant for MAXONA Pharmaceuticals. SOURCE Maxona Pharmaceuticals 21% more press release views with Request a Demo

这两天有些标题耸人听闻，多款进口药品要退出中国市场。药品是特殊的商品，既然是商品就是要卖钱的，中国市场那么大，只要有利润没有一家药企会退出中国市场的。何况现在的中国还是老龄化中国，药品的需求不会变低，只会越来越高。只要你有钱，你就能享受到更好的药品。可以关注下这几年申请注销的情形，不要对一次事件进行过分的解读。 只要你的创新能力足够强，是个医药巨头都应该想和你扳扳手腕吧。谁不想成为世界第一，没了挑战性那还是商人吗？药品的退出只能是说这个药品在同类产品竞争中已经没有优势了，不可能有人赔钱赚吆喝的。 我们应该是防内卷，不要到时候别人没死，我们自己先死了，比起多款药品的退市。第十一轮国家药品集采，印度企业以2.15毛/片远低于其他竞争者的价格脱颖而出（低于报价次低24%），拿下第一顺位中标资格。以前是喝粥，现在是要喝水了吗。 创新药干不过外企 仿制药干不过印度 中草药干不过日本 国家药监局注销80个药品注册证书（2025年第102号公告） 以下药品因企业依申请注销，自公告之日起，不得继续生产、销售和使用。 序号 药品通用名称 批准文号 剂型 规格 药品上市许可持有人 注销情形 1 氯雷他定片 国药准字H20040557 片剂 10mg 费森尤斯卡比华瑞制药有限公司 依申请注销 2 酒石酸长春瑞滨软胶囊 国药准字H20061234 胶囊剂 20mg（按长春瑞滨计） 江苏恒瑞医药股份有限公司 依申请注销 3 异烟肼片 国药准字H32022318 片剂 100mg 太仓制药厂 依申请注销 4 异烟肼片 国药准字H20073372 片剂 300mg 太仓制药厂 依申请注销 5 复方利血平片 国药准字H32026529 片剂 复方 太仓制药厂 依申请注销 6 桂利嗪片 国药准字H32021557 片剂 25mg 太仓制药厂 依申请注销 7 保泰松片 国药准字H32023069 片剂 0.1g 太仓制药厂 依申请注销 8 盐酸奈福泮片 国药准字H32021556 片剂 20mg 太仓制药厂 依申请注销 9 甲硝唑片 国药准字H32021559 片剂 0.2g 太仓制药厂 依申请注销 10 肌苷片 国药准字H32022319 片剂 0.2g 太仓制药厂 依申请注销 11 盐酸小檗碱片 国药准字H32026776 片剂 0.1g 太仓制药厂 依申请注销 12 奋乃静片 国药准字H32022315 片剂 2mg 太仓制药厂 依申请注销 13 维生素B2片 国药准字H32022320 片剂 5mg 太仓制药厂 依申请注销 14 注射用盐酸多柔比星 国药准字H20013334 注射剂 10mg（按C27H29NO11HCL计算） 辉瑞制药（无锡）有限公司 依申请注销 15 非那雄胺片 国药准字H20041908 片剂 5mg 南京美瑞制药有限公司 依申请注销 16 萘哌地尔片 国药准字H20020320 片剂 25mg 南京美瑞制药有限公司 依申请注销 17 五维他口服溶液 国药准字H32026635 口服溶液剂 复方 金陵药业股份有限公司南京金陵制药厂 依申请注销 18 复方愈创木酚磺酸钾口服溶液 国药准字H32026580 口服溶液剂 复方 金陵药业股份有限公司南京金陵制药厂 依申请注销 19 利福定胶囊 国药准字H32026114 胶囊剂 0.15g 金陵药业股份有限公司南京金陵制药厂 依申请注销 20 复方磺胺甲噁唑注射液 国药准字H32025719 注射剂 2ml:磺胺甲噁唑0.4g,甲氧苄啶80mg  金陵药业股份有限公司南京金陵制药厂 依申请注销 21 葡萄糖注射液 国药准字H20055131 注射剂 50ml:2.5g 华裕（无锡）制药有限公司 依申请注销 22 葡萄糖注射液 国药准字H20055132 注射剂 50ml:5g 华裕（无锡）制药有限公司 依申请注销 23 注射用盐酸克林霉素 国药准字H20041124 注射剂 0.75g（按克林霉素计） 海南双成药业股份有限公司 依申请注销 24 注射用盐酸克林霉素 国药准字H20041125 注射剂 0.6g（按克林霉素计） 海南双成药业股份有限公司 依申请注销 25 注射用盐酸克林霉素 国药准字H20051177 注射剂 0.45g（按克林霉素计） 海南双成药业股份有限公司 依申请注销 26 注射用肌苷 国药准字H20050861 注射剂 0.5g 海南双成药业股份有限公司 依申请注销 27 注射用肌苷 国药准字H20041230 注射剂 0.2g 海南双成药业股份有限公司 依申请注销 28 注射用肌苷 国药准字H20050862 注射剂 0.6g 海南双成药业股份有限公司 依申请注销 29 注射用肌苷 国药准字H20050859 注射剂 0.4g 海南双成药业股份有限公司 依申请注销 30 盐酸左氧氟沙星氯化钠注射液 国药准字H20040828 注射剂 100ml:左氧氟沙星0.5g与氯化钠0.9g 海南爱科制药有限公司 依申请注销 31 维生素B6注射液 国药准字H61021132 注射剂 1ml:50mg 西藏邦臣药业集团有限公司 依申请注销 32 肌苷注射液 国药准字H61022389 注射剂 2ml:50mg 西藏邦臣药业集团有限公司 依申请注销 33 双氯芬酸钠肠溶片 国药准字H44020314 片剂 25mg 特一药业集团股份有限公司 依申请注销 34 单唾液酸四己糖神经节苷脂钠注射液 国药准字H20066833 注射剂 2ml:20mg 长春翔通药业有限公司 依申请注销 35 复方角菜酸酯乳膏 国药准字H20093799 乳膏剂 每100克含角菜酸酯2.5克、二氧化钛2克、氧化锌2克、利多卡因2克。 西安杨森制药有限公司 依申请注销 36 复方角菜酸酯栓 国药准字H20083150 栓剂 每枚3.4g 西安杨森制药有限公司 依申请注销 37 苄达赖氨酸滴眼液 国药准字H20063964 滴眼剂 8毫升:40毫克 乐声药业石家庄有限公司 依申请注销 38 注射用重组人II型肿瘤坏死因子受体-抗体融合蛋白 国药准字S20150005 注射剂 12.5mg/瓶,生物学活性为1.25×106AU/瓶 杭州博之锐生物制药有限公司 依申请注销 39 甲型肝炎灭活疫苗（人二倍体细胞） 国药准字SJ20140055 注射剂 25U/0.5ml/支 Merck Sharp & Dohme LLC 依申请注销 40 甲型肝炎灭活疫苗（人二倍体细胞） 国药准字SJ20140056 注射剂 50U/1.0ml/支 Merck Sharp & Dohme LLC 依申请注销 41 甲型肝炎灭活疫苗（人二倍体细胞） 国药准字SJ20140107 注射剂 25U/0.5ml/支 Merck Sharp & Dohme LLC 依申请注销 42 甲型肝炎灭活疫苗（人二倍体细胞） 国药准字SJ20140108 注射剂 50U/1.0ml/支 Merck Sharp & Dohme LLC 依申请注销 43 马吉妥昔单抗注射液 国药准字SJ20230009 注射剂 250mg（10ml）/瓶 MacroGenics,Inc. 依申请注销 44 依洛硫酸酯酶α注射液 S20190024 注射剂 每瓶5mL,含依洛硫酸酯酶α5mg（1mg/ml）。 BioMarin International Limited 依申请注销 45 盐酸巴尼地平缓释胶囊 国药准字HJ20140490 胶囊剂 10mg LTL Pharma Co., Ltd. 依申请注销 46 盐酸巴尼地平缓释胶囊 国药准字HJ20140491 胶囊剂 10mg LTL Pharma Co., Ltd. 依申请注销 47 盐酸巴尼地平缓释胶囊 国药准字HJ20140492 胶囊剂 15mg LTL Pharma Co., Ltd. 依申请注销 48 盐酸巴尼地平缓释胶囊 国药准字HJ20140493 胶囊剂 15mg LTL Pharma Co., Ltd. 依申请注销 49 美沙拉秦栓 国药准字HJ20140947 栓剂 0.25g Dr. Falk Pharma GmbH 依申请注销 50 美沙拉秦栓 国药准字HJ20150314 栓剂 1g Dr. Falk Pharma GmbH 依申请注销 51 注射用福莫司汀 国药准字HJ20150552 注射剂 208mg/瓶 LES LABORATOIRES SERVIER 依申请注销 52 吲达帕胺片 国药准字HJ20160320 片剂 2.5mg LES LABORATOIRES SERVIER 依申请注销 53 芬太尼透皮贴剂 国药准字HJ20150591 贴剂 12微克/小时 2.1mg/贴 Janssen-Cilag NV 依申请注销 54 芬太尼透皮贴剂 国药准字HJ20150592 贴剂 25微克/小时,4.2mg/贴 Janssen-Cilag NV 依申请注销 55 芬太尼透皮贴剂 国药准字HJ20150593 贴剂 75微克/小时,12.6mg/贴 Janssen-Cilag NV 依申请注销 56 芬太尼透皮贴剂 国药准字HJ20150594 贴剂 50微克/小时,8.4mg/贴 Janssen-Cilag NV 依申请注销 57 芬太尼透皮贴剂 国药准字HJ20150595 贴剂 25微克/小时,4.2mg/贴 Janssen-Cilag NV 依申请注销 58 芬太尼透皮贴剂 国药准字HJ20150596 贴剂 50微克/小时,8.4mg/贴 Janssen-Cilag NV 依申请注销 59 吸入用硫酸沙丁胺醇溶液 国药准字HJ20160660 吸入溶液剂 2.5ml：5mg（以沙丁胺醇计） GlaxoSmithKline Australia Pty Ltd. 依申请注销 60 磷酸雌莫司汀胶囊 国药准字HJ20170266 胶囊剂 0.14g Pfizer Italia S.r.l. 依申请注销 61 多替阿巴拉米片 国药准字HJ20170345 片剂 每片含多替拉韦钠（以多替拉韦计）50mg、硫酸阿巴卡韦（以阿巴卡韦计）600mg和拉米夫定300mg ViiV Healthcare BV 依申请注销 62 利司那肽注射液 国药准字HJ20170370 注射剂 10μg剂量注射笔（绿色）：0.05mg/ml,3ml/支, 单次注射药量10μg（0.2ml）  Sanofi Winthrop Industrie 依申请注销 63 利司那肽注射液 国药准字HJ20170371 注射剂 20μg剂量注射笔（深紫红色）:0.10mg/ml,3ml/支,单次注射药量20μg（0.2ml）  Sanofi Winthrop Industrie 依申请注销 64 利司那肽注射液 国药准字HJ20170372 注射剂 20μg剂量注射笔（深紫红色）:0.10mg/ml,3ml/支,单次注射药量20μg（0.2ml）  Sanofi Winthrop Industrie 依申请注销 65 利司那肽注射液 国药准字HJ20170373 注射剂 10μg剂量注射笔（绿色,单次注射药量10μg）和20μg剂量注射笔（深紫红色,单次注射药量20μg）  Sanofi Winthrop Industrie 依申请注销 66 利司那肽注射液 国药准字HJ20171314 注射剂 10μg剂量注射笔（绿色）:0.05mg/ml,3ml/支, 单次注射药量10μg（0.2ml）  Sanofi Winthrop Industrie 依申请注销 67 利司那肽注射液 国药准字HJ20171315 注射剂 20μg剂量注射笔（深紫红色）:0.10mg/ml,3ml/支, 单次注射药量20μg（0.2ml）  Sanofi Winthrop Industrie 依申请注销 68 格隆溴铵吸入粉雾剂 国药准字HJ20180002 吸入粉雾剂 50μg（以C₁₉H₂₈NO₃计） Novartis Pharma Schweiz AG 依申请注销 69 格隆溴铵吸入粉雾剂 国药准字HJ20180003 吸入粉雾剂 50μg（以C₁₉H₂₈NO₃计） Novartis Pharma Schweiz AG 依申请注销 70 达芦那韦考比司他片 国药准字HJ20180030 片剂 每片含800mg达芦那韦（相当于867.28mg达芦那韦乙醇合物）和150mg考比司他 Janssen-Cilag International N.V. 依申请注销 71 二甲双胍恩格列净片（III） 国药准字HJ20190025 片剂 每片含盐酸二甲双胍850mg与恩格列净5mg Boehringer Ingelheim International GmbH 依申请注销 72 二甲双胍恩格列净片（V） 国药准字HJ20190026 片剂 每片含盐酸二甲双胍1000mg与恩格列净5mg Boehringer Ingelheim International GmbH 依申请注销 73 二甲双胍恩格列净片（Ⅳ） 国药准字HJ20190027 片剂 每片含盐酸二甲双胍850mg与恩格列净12.5mg Boehringer Ingelheim International GmbH 依申请注销 74 二甲双胍恩格列净片（VI） 国药准字HJ20190028 片剂 每片含盐酸二甲双胍1000mg与恩格列净12.5mg Boehringer Ingelheim International GmbH 依申请注销 75 二甲双胍恩格列净片（III） 国药准字HJ20201009 片剂 每片含盐酸二甲双胍850mg与恩格列净5mg Boehringer Ingelheim International GmbH 依申请注销 76 二甲双胍恩格列净片（Ⅳ） 国药准字HJ20201010 片剂 每片含盐酸二甲双胍850mg与恩格列净12.5mg Boehringer Ingelheim International GmbH 依申请注销 77 氨吡啶缓释片 国药准字HJ20210031 片剂 10mg Biogen Netherlands B.V. 依申请注销 78 利伐沙班干混悬剂 国药准字HJ20220044 干混悬剂 103.4mg Bayer AG 依申请注销 79 利伐沙班干混悬剂 国药准字HJ20220045 干混悬剂 51.7mg Bayer AG 依申请注销 80 注射用盐酸可泮利塞 国药准字HJ20230056 注射剂 60mg（按C₂₃H₂₈N₈O₄计 ） Bayer HealthCare Pharmaceuticals Inc. 依申请注销 请转发给身边正在用药的亲友，核对药盒批准文号，如发现被注销药品，立即停用并咨询医生。