Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.

开始日期2024-03-25

申办/合作机构

McLean Hospital, Inc.

[+1]

CTR20240211 / CompletedN/A

随机、开放、两制剂、两序列、两周期、自身交叉对照设计，评价中国健康受试者在空腹及餐后状态下单次口服萘普生钠片后的生物等效性正式试验

以呋欧医药科技（湖州）有限公司提供的萘普生钠片为受试制剂；并以Atnahs Pharma Netherlands B.V.的萘普生钠片为参比制剂，进行人体相对生物利用度和生物等效性评价。

开始日期2024-02-20

申办/合作机构

呋欧医药科技（湖州）有限公司

CTR20231229 / CompletedN/A

萘普生钠片（275mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Atnahs Pharma Netherlands B.V.为持证商的萘普生钠片（商品名：Apranax®，规格：275mg）为参比制剂，对长春海悦药业股份有限公司生产的受试制剂萘普生钠片（规格：0.275g（相当于萘普生250mg））进行空腹给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂萘普生钠片（规格：0.275g（相当于萘普生250mg））和参比制剂萘普生钠片（商品名：Apranax®，规格：275mg）的安全性。

开始日期2023-07-01

申办/合作机构

长春海悦药业股份有限公司

100 项与萘普生钠相关的临床结果

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100 项与萘普生钠相关的转化医学

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100 项与萘普生钠相关的专利（医药）

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523

项与萘普生钠相关的文献（医药）

2024-01-29·American journal of obstetrics and gynecology

Ultrasound and MRI-based investigation of the role of perfusion and oxygen availability in menstrual pain.

Article

作者: Richard H Cockrum ; Frank F Tu ; Ola Kierzkowska ; Nondas Leloudas ; Prasad V Pottumarthi ; Kevin M Hellman

BACKGROUND:

The mechanisms responsible for menstrual pain are poorly understood. However, dynamic noninvasive pelvic imaging of menstrual pain sufferers could aid in identifying therapeutic targets and in testing novel treatments.

OBJECTIVE:

To study the mechanisms responsible for menstrual pain, we analyzed ultrasonographic and complementary functional Magnetic Resonance Imaging (fMRI) parameters in dysmenorrhea sufferers and pain-free controls under multiple conditions.

STUDY DESIGN:

We performed fMRI on participants with and without dysmenorrhea during menses and non-menses. To clarify whether regional changes in oxygen availability and perfusion occur, fMRI R2* measurements were made of the endometrium and myometrium. R2* measurements are calculated nuclear magnetic resonance relaxation rates sensitive to the paramagnetic properties of oxygenated and deoxygenated hemoglobin. We also compared parameters before and after an analgesic dose of naproxen sodium. In addition, we performed similar measurements with Doppler ultrasonography to identify whether changes in uterine arterial velocity occurred during menstrual cramping in real time. Mixed model statistics were performed to account for within-subject effects across conditions. Corrections for multiple comparisons were made with a false discovery rate adjustment.

RESULTS:

During menstruation, a notable increase in R2* values, indicative of tissue ischemia, was observed in both the myometrium (beta ± standard error of the mean: 15.74 ± 2.29 s^-1, p = 0.001, q = 0.002) and the endometrium (26.37 ± 9.33 s^-1, p = 0.005, q = 0.008) among participants experiencing dysmenorrhea. A similar increase was noted in the myometrium (28.89 ± 2.85 s^-1, p = 0.001, q = 0.002) and endometrium (75.50 ± 2.57 s^-1, p = 0.001, q = 0.003) among pain-free controls. Post-hoc analyses revealed that R2* values during menstruation were significantly higher than those in participants with dysmenorrhea (Myometrium: p = 0.008, Endometrium: p = 0.043). Whereas naproxen sodium increased endometrial R2* in participants with dysmenorrhea (48.29 ± 15.78 s^-1,p = 0.005, q = 0.008), it decreased myometrial R2*in pain-free controls. Doppler findings were consistent with fMRI (-8.62 ± 3.25 s^-1, p = 0.008, q = 0.011). The pulsatility index (-0.42 ± 0.14, p = 0.004, q = 0.004) and resistance index (-0.042 ± 0.012, p = 0.001, q = 0.001) decreased during menses compared with non-menses, and effects were significantly reversed by naproxen sodium. Naproxen sodium had the opposite effect in pain-free controls. There were no significant real-time changes in the pulsatility index, resistance index, peak systolic velocity, or minimum diastolic velocity during episodes of symptomatic menstrual cramping.

CONCLUSIONS:

fMRI and Doppler metrics suggest participants with dysmenorrhea have better perfusion and oxygen availability than pain-free controls. Naproxen sodium's therapeutic mechanism is associated with relative reductions in uterine perfusion and oxygen availability. An opposite pharmacological effect was observed in pain-free controls. During menstrual cramping, there is insufficient evidence of episodic impaired uterine perfusion. Thus, prostaglandins may have protective vasoconstrictive effects in pain-free controls and opposite effects among participants with dysmenorrhea.

2024-01-01·Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques

What a pain in the … back: a review of current treatment options with a focus on naproxen sodium.

Review

作者: Steven M Weisman ; Giovanni Ciavarra ; Grant Cooper

Non-specific low back pain (LBP) represents a challenging and prevalent condition that is one of the most common symptoms leading to primary care physician visits. While established guidelines recommend prioritizing non-pharmacological approaches as the primary course of action, pharmacological treatments are advised when non-pharmacological approaches are ineffective or based on patient preference. These guidelines recommend non-steroidal anti-inflammatory drugs (NSAIDs) or skeletal muscle relaxers (SMRs) as the first-line pharmacological options for acute or subacute LBP, while NSAIDs are the exclusive first-line pharmacological option for chronic LBP. Although SMRs are generally effective for acute LBP, the available evidence does not support the view that they improve functional recovery, and their comparative efficacy to NSAIDs and other analgesics remains unknown, while studies have shown them to introduce adverse events without significantly reducing LBP. Moreover, opioids continue to be widely prescribed for LBP, despite limited evidence for effectiveness and known risks of addiction and overdose. Broader use of non-opioid pharmacotherapy, including the appropriate use of OTC options, is critical to addressing the opioid crisis. The balance of evidence indicates that NSAIDs have a favorable benefit-risk profile when compared to other available pharmacological treatment options for non-specific LBP, a condition that is primarily acute in nature and well-suited for self-treatment with OTC analgesics. While clinical guidelines do not differentiate between NSAIDs, evidence indicates that OTC naproxen sodium effectively relieves pain across multiple types of pain models, and furthermore, the 14-h half-life of naproxen sodium allows sustained, all day pain relief with reduced patient pill burden as compared to shorter acting options. Choosing the most appropriate approach for managing LBP, including non-pharmacological options, should be based on the patient's condition, severity of pain, potential risks, and individual patient preference and needs.

2023-12-21·Current medical research and opinion

Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model.

Article

作者: Andrew Myers ; Cathy Gelotte ; Annette Zuckerman ; Brenda Zimmerman ; Ami Shenoy ; Dan Qi ; Stephen A Cooper

OBJECTIVES:

Speed of onset can be critical to an analgesic's efficacy treating acute pain. To enhance onset, a new oral acetaminophen formulation intended to be fast acting was developed. Two studies evaluated analgesic onset, efficacy, and safety of this fast-acting acetaminophen (FA-acetaminophen) tablet relative to commercial acetaminophen caplets (ES-acetaminophen) and commercial ibuprofen liquid-filled gelatin capsules (LG-ibuprofen).

METHODS:

Two single-center, single-dose, inpatient, randomized, double-blind, triple-dummy, placebo-controlled, parallel group design clinical trials were conducted using the postoperative dental impaction pain model. Subjects were healthy men and women aged 17 to 50 years experiencing moderate-to-severe pain after surgical extraction of at least 3 impacted third molars. In both studies, 4 treatment groups were evaluated: 1000 mg acetaminophen as two 500 mg FA-acetaminophen tablets, 1000 mg as two 500 mg ES-acetaminophen caplets, 400 mg ibuprofen as two 200 mg LG-ibuprofen capsules, and placebo. To maintain blinding, each subject received 6 units of study medication. Times to confirmed perceptible pain relief (TCPR) and meaningful pain relief (TMPR) were obtained using the double-stopwatch method. Pain intensity and relief were measured over 6 hours following drug administration using a 0-10 numerical rating scale. Time to use of rescue medication (naproxen sodium) and subject global evaluations of study medications at 6 hours were collected. Pharmacokinetic blood sampling and safety assessments were performed.

RESULTS:

Studies 1 and 2 enrolled 240 and 420 subjects, respectively. No clinically important differences among treatment groups were observed for any demographic or baseline characteristics. Efficacy results showed all active treatments statistically superior to placebo. In Study 1, TCPR was statistically significantly shorter for FA-acetaminophen compared to ES-acetaminophen and LG-ibuprofen. In Study 2, no statistically significant differences in TCPR were noted across the active treatment groups. In Study 1, FA-acetaminophen 1000 mg provided significantly shorter TMPR compared with LG-ibuprofen but not compared with ES-acetaminophen. In Study 2, no significant differences in TMPR were noted across the active treatment groups. In both Study 1 and 2 at 15 min after administration of study drug, PID and PAR scores were greater for FA-acetaminophen than LG-ibuprofen.

CONCLUSIONS:

Both studies suggested FA-acetaminophen had faster onset of action compared to ES-acetaminophen and LG-Ibuprofen. In light of the difference in TCPR and TMPR results between Study 1 and 2, an additional study is needed to further investigate time to analgesic onset of FA-acetaminophen compared with ES-acetaminophen and LG-Ibuprofen.

STUDY REGISTRY NUMBERS:

Study 1: NCT02735122; Study 2: NCT03224403.

项与萘普生钠相关的新闻（医药）

2024-03-25

·BioSpace

Aleve® Speaks The Painful Truth, Encouraging Consumers to Explore Their Pain Management Options

The new initiative spotlights real pain sufferers who share moving, firsthand accounts of opioid use disorder with consumers seeking pain relief options. WHIPPANY, N.J.--(BUSINESS WIRE)-- Aleve®, a marquee pain relief product from Bayer indicated for minor pain, in partnership with Mothers Against Prescription Drug Abuse (MAPDA), today launched “The Painful Truth,” a campaign developed to encourage consumers to explore, with their doctors, pain relief options such as over-the-counter (OTC) products before taking opioids, when appropriate. This press release features multimedia. View the full release here: Aleve launches "The Painful Truth" campaign with Mothers Against Prescription Drug Abuse (MAPDA) and National Consumers League (NCL). (Photo: Business Wire) While opioid dispensing rates in the U.S. are slowly ticking down, they remain elevated compared with rates in other countries. The U.S. makes up only 4.4% of the world’s population, but it consumes over 80% of the world’s opioids. Luckily, consumers today have more options than ever before for powerful, nonaddictive pain relief as they navigate their unique positions on the overall pain spectrum, including but not limited to OTC medications, physical therapy, medication and chiropractic care. “The Painful Truth” campaign launches with a three-minute film featuring real pain sufferers who are at crossroads in their pain relief journeys and seeking guidance. The featured patients believe they are participating in a video call with a pain expert who will help them explore their options, but as the conversation progresses, our “expert” reveals that they are in fact in recovery from opioid use disorder. At this critical juncture in their care, the patients are encouraged to consider different pain relief options. “Two big contributing factors to opioid use disorder are lack of education around the potential negative consequences of opioid use and the enduring stigma around addiction. Many of us believe this could never happen to us or someone we love, and that often prevents patients from exploring options for pain relief,” said Mary Bono, co-founder, chair of the board of directors and CEO of MAPDA. “At MAPDA, we encourage people to engage in the vital conversations around drug impacts, and we are so proud to partner with Aleve on ‘The Painful Truth’ to shine a spotlight on that moment when patients should actively engage about their care and explore all viable options.” Beyond uncovering raw stories of opioid use disorder and its impacts, the campaign challenges patients to fully explore and understand the drugs they are prescribed before using them. The CDC recommends maximizing non-opioid therapies as appropriate before using opioids for acute pain.1 “The Painful Truth” website provides information on nonaddictive pain relief options, like Aleve, and various research-backed, supportive therapies, including physical therapy, aromatherapy, chiropractic care, yoga, restorative sleep and meditation. “We know there are instances when prescription opioids may be the best course of treatment for some patients, but we want patients with minor pain to know about less addictive options that can be used as the first line of treatment,” said Jeff Jarrett, chief marketing officer, Bayer Consumer Health, North America. “In a clinical study, Aleve was found to be as strong on pain and longer lasting than hydrocodone plus acetaminophen (HYD+APAP).2 Patients should always talk to their doctors to learn about their pain relief options based on their diagnoses.” To learn more, view the film and hear “expert” stories, visit aleve.com/thepainfultruth. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to bayer.com. About Mothers Against Prescription Drug Abuse (MAPDA) Founded in 2011, Mothers Against Prescription Drug Abuse is a nationally recognized 501(c)(3) nonprofit organization focused on policy advocacy, opioid use disorder (OUD) prevention education and opioid awareness programs. For more information, visit mapda.net. 1Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1–95. DOI: 2In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg), HYD+APAP (10 mg + 650 mg), or placebo. View source version on businesswire.com: Contacts Christin Miller, Director of Strategic Communications, christin.miller@bayer.com Kalley Jolly, MLPR, kalley.jolly@mullenlowe.com Source: Bayer Smart Multimedia Gallery Photo Aleve launches "The Painful Truth" campaign with Mothers Against Prescription Drug Abuse (MAPDA) and National Consumers League (NCL). (Photo: Business Wire) Video The Painful Truth campaign video tells the real-life story of pain advocate, Matt Robinson, and his journey from addiction to advocacy. Logo Logo View this news release and multimedia online at:

2023-11-13

·信狐药迅

南京博德左奥拉西坦上市申请，McNeil 尼古丁口腔喷雾剂进口申请 | 新受理（11.6-11.12）

每周药品注册受理数据，分门别类呈现，一目了然。(11.6-11.12）新药上市申请药品名称企业名称分类受理号HR20031片(Ⅰ)山东盛迪医药有限公司2.3CXHS2300099HR20031片(Ⅱ)山东盛迪医药有限公司2.3CXHS2300100人凝血酶原复合物国药集团兰州生物制药有限公司3.4CXSS2300087注射用左奥拉西坦南京博德生物制药有限公司2.1CXHS2300098新药临床申请药品名称企业名称分类受理号ABP1019A片上海爱博医药科技有限公司1CXHL2301224ABP1019A片上海爱博医药科技有限公司1CXHL2301225AZD0901阿斯利康全球研发(中国)有限公司1CXSL2300767AZD0901阿斯利康全球研发(中国)有限公司1CXSL2300765BGB-15025片百济神州(苏州)生物科技有限公司1CXHL2301247BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2301219BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2301220BGB-43395片百济神州(苏州)生物科技有限公司1CXHL2301221BR115注射液浙江博锐生物制药有限公司1CXSL2300772CG2001北京辰光医药科技有限公司2.2CXHL2301246CMS-D001片海南康哲美丽科技有限公司1CXHL2301250CMS-D001片海南康哲美丽科技有限公司1CXHL2301251CMS-D001片海南康哲美丽科技有限公司1CXHL2301252DA414颗粒成都地奥九泓制药厂1CXHL2301248DA414颗粒成都地奥九泓制药厂1CXHL2301249FCN-338片上海复星医药产业发展有限公司1CXHL2301258FCN-338片上海复星医药产业发展有限公司1CXHL2301259HRS-7535片山东盛迪医药有限公司1CXHL2301253HRS-7535片山东盛迪医药有限公司1CXHL2301254HS-10501片江苏豪森药业集团有限公司1CXHL2301236HS-10501片上海翰森生物医药科技有限公司1CXHL2301237HS-10501片江苏豪森药业集团有限公司1CXHL2301238HS-10501片江苏豪森药业集团有限公司1CXHL2301239HS-10501片江苏豪森药业集团有限公司1CXHL2301240HS-10501片江苏豪森药业集团有限公司1CXHL2301241HS-10509片江苏豪森药业集团有限公司1CXHL2301242HS-10509片江苏豪森药业集团有限公司1CXHL2301243HS-10509片江苏豪森药业集团有限公司1CXHL2301244ND-003片深圳市新樾生物科技有限公司1CXHL2301227ND-003片深圳市新樾生物科技有限公司1CXHL2301228QR056240CR片武汉朗来科技发展有限公司1CXHL2301222QR056240CR片武汉朗来科技发展有限公司1CXHL2301223SYN045片石家庄四药有限公司1CXHL2301230SYN045片石家庄四药有限公司1CXHL2301231SYN045片石家庄四药有限公司1CXHL2301232SYN045片石家庄四药有限公司1CXHL2301233SYN045片石家庄四药有限公司1CXHL2301234SYN045片石家庄四药有限公司1CXHL2301235ZS805注射液四川至善唯新生物科技有限公司1CXSL2300775人脐带间充质干细胞注射液广州达博生物制品有限公司1CXSL2300769人脐带间充质干细胞注射液深圳市茵冠生物科技有限公司1CXSL2300770注射用AMT-116普众发现医药科技(上海)有限公司1CXSL2300771注射用JMKX003142浙江杭煜制药有限公司1CXHL2301229注射用MK-2870默沙东研发(中国)有限公司1CXSL2300774注射用RC88荣昌生物制药(烟台)股份有限公司1CXSL2300768注射用SHR-A1921苏州盛迪亚生物医药有限公司1CXSL2300766盐酸右美托咪定鼻喷雾剂石药集团中奇制药技术(石家庄)有限公司2.4CXHL2301255盐酸氨酮戊酸颗粒剂上海复旦张江生物医药股份有限公司2.4CXHL2301260硫酸阿托品滴眼液苏州欧康维视生物科技有限公司2.4CXHL2301256硫酸阿托品滴眼液苏州欧康维视生物科技有限公司2.4CXHL2301257硫酸阿托品滴眼液乐普药业股份有限公司2.4CXHL2301261硫酸阿托品滴眼液乐普药业股份有限公司2.4;2.2CXHL2301262碳[13C]美沙西汀肝脏储备功能诊断药盒北京华亘安邦科技有限公司2.2CXHL2301245重组抗IL-1β人源化单克隆抗体注射液三生国健药业(上海)股份有限公司1CXSL2300773阿哌沙班胃滞留缓释胶囊南京三迭纪医药科技有限公司2.2CXHL2301226仿制药申请药品名称企业名称分类受理号中/长链脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHS2303030中/长链脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHS2303031中/长链脂肪乳注射液(C6-24)四川科伦药业股份有限公司4CYHS2303032乙酰半胱氨酸注射液山西阳和医药技术有限公司3CYHS2303064乳果糖口服溶液云鹏医药集团有限公司4CYHS2303044二十碳五烯酸乙酯软胶囊山东新华制药股份有限公司4CYHS2303096二十碳五烯酸乙酯软胶囊山东新华制药股份有限公司4CYHS2303097依托考昔片云鹏医药集团有限公司4CYHS2303103依托考昔片云鹏医药集团有限公司4CYHS2303104依折麦布片云南龙津康佑生物医药有限公司4CYHS2303082利格列汀片山东朗诺制药有限公司4CYHS2303095卡前列素氨丁三醇注射液湖南华纳大药厂股份有限公司4CYHS2303074叶酸片沈阳天邦药业有限公司3CYHS2303033吡拉西坦注射液山东化药医药科技有限公司3CYHS2303048吡拉西坦注射液山东化药医药科技有限公司3CYHS2303049吡拉西坦注射液山东化药医药科技有限公司3CYHS2303050吡格列酮二甲双胍片江苏安必生制药有限公司3CYHS2303085地夸磷索钠滴眼液南京帝昌医药科技有限公司4CYHS2303015地奈德软膏杭州领业医药科技有限公司3CYHS2303027培哚普利氨氯地平片(III)江苏万珺医药科技有限公司4CYHS2303047复合磷酸氢钾注射液成都米子生物医药科技有限公司3CYHS2303010复方氨基酸注射液(18AA-VII)山东齐都药业有限公司4CYHS2303086复方甘草酸苷片浙江美迪深生物医药有限公司4CYHS2303019复方醋酸钠林格注射液辽宁民康制药有限公司3CYHS2303075复方醋酸钠林格注射液辽宁民康制药有限公司3CYHS2303076多种微量元素注射液(I)合肥市未来药物开发有限公司3CYHS2303077多种微量元素注射液(I)合肥市未来药物开发有限公司3CYHS2303078奥利司他胶囊大邦(湖南)生物制药有限公司4CYHS2303012奥利司他胶囊大邦(湖南)生物制药有限公司4CYHS2303013奥美沙坦酯氨氯地平片江苏联环药业股份有限公司4CYHS2303069富马酸伏诺拉生片宁波科尔康美诺华药业有限公司4CYHS2303017富马酸伏诺拉生片宁波科尔康美诺华药业有限公司4CYHS2303018富马酸福莫特罗吸入溶液南京力成药业有限公司4CYHS2303034对乙酰氨基酚布洛芬片长春澜江医药科技有限公司3CYHS2303092尼可地尔片湖南九典制药股份有限公司4CYHS2303020左炔诺孕酮片广州朗圣药业有限公司4CYHS2303011布洛芬注射液山东新华制药股份有限公司3CYHL2300136布洛芬注射液陕西丽彩药业有限公司3CYHS2303062布洛芬注射液陕西丽彩药业有限公司3CYHS2303063布美他尼注射液齐鲁制药(海南)有限公司3CYHS2303056托拉塞米注射液湖北亨迪药业股份有限公司3CYHS2303067托拉塞米注射液湖北亨迪药业股份有限公司3CYHS2303068拉考沙胺注射液浙江华海药业股份有限公司4CYHS2303102氟比洛芬凝胶贴膏河南羚锐制药股份有限公司4CYHL2300135氯化钾口服溶液山东朗诺制药有限公司3CYHS2303094氯化钾口服溶液成都倍特得诺药业有限公司3CYHS2303070氯化钾口服溶液成都倍特得诺药业有限公司3CYHS2303071氯化钾注射液华夏生生药业(北京)有限公司3CYHS2303022氯化钾颗粒山西皇城相府药业股份有限公司3CYHS2303099氯化钾颗粒山西皇城相府药业股份有限公司3CYHS2303100氯化钾颗粒山西阳和医药技术有限公司3CYHS2303028氯化钾颗粒山西阳和医药技术有限公司3CYHS2303029法莫替丁注射液海南慧通生物医药科技有限公司3CYHS2303043法莫替丁注射液成都欣捷高新技术开发股份有限公司3CYHS2303025注射用盐酸地尔硫䓬舒美奇成都生物科技有限公司4CYHS2303042盐酸屈他维林注射液北京沃邦医药科技有限公司4CYHS2303060盐酸甲氧氯普胺注射液海南紫程众投生物科技有限公司3CYHS2303024盐酸纳洛酮注射液重庆中创科医药有限公司3CYHS2303079盐酸纳洛酮注射液重庆中创科医药有限公司3CYHS2303080盐酸贝尼地平片重庆煜洋药业有限公司4CYHS2303035硫酸氨基葡萄糖胶囊哈尔滨中泰医药有限公司4CYHS2303014磷酸奥司他韦干混悬剂海南葫芦娃药业集团股份有限公司3CYHS2303053磷酸奥司他韦干混悬剂宏越科技(湖州)有限公司3CYHS2303054米诺地尔搽剂广州康药师医药科技有限公司3CYHS2303072米诺地尔泡沫剂山东致泰医药技术有限公司3CYHS2303026精氨酸布洛芬颗粒石家庄四药有限公司4CYHS2303081维生素K1注射液海南倍特药业有限公司3CYHS2303087维生素K1注射液海南倍特药业有限公司3CYHS2303088罗沙司他胶囊海口市制药厂有限公司4CYHS2303051罗沙司他胶囊海口市制药厂有限公司4CYHS2303052聚乙二醇钠钾散南京海纳制药有限公司4CYHS2303083艾地骨化醇软胶囊正大制药(青岛)有限公司4CYHS2303057艾地骨化醇软胶囊正大制药(青岛)有限公司4CYHS2303058萘普生钠片长春海悦药业股份有限公司3CYHS2303023西罗莫司凝胶福建科瑞药业有限公司4CYHS2303061贝美素噻吗洛尔滴眼液杭州民生药业股份有限公司4CYHS2303101达格列净二甲双胍缓释片(I)浙江华海药业股份有限公司4CYHS2303036达格列净二甲双胍缓释片(I)浙江华海药业股份有限公司4CYHS2303037达格列净二甲双胍缓释片(III)浙江华海药业股份有限公司4CYHS2303038达格列净二甲双胍缓释片(IV)浙江华海药业股份有限公司4CYHS2303039达格列净片惠升生物制药股份有限公司4CYHS2303089达格列净片惠升生物制药股份有限公司4CYHS2303090醋酸钙片吉林省辉南长龙生化药业股份有限公司3CYHS2303084醋酸钠林格注射液浙江康吉尔药业有限公司3CYHS2303093重酒石酸去甲肾上腺素注射液成都旭阳永健医药科技有限公司3CYHS2303065重酒石酸去甲肾上腺素注射液成都旭阳永健医药科技有限公司3CYHS2303066重酒石酸去甲肾上腺素注射液嘉实(湖南)医药科技有限公司3CYHS2303040重酒石酸去甲肾上腺素注射液嘉实(湖南)医药科技有限公司3CYHS2303041重酒石酸去甲肾上腺素注射液中润药业有限公司3CYHS2303045重酒石酸去甲肾上腺素注射液中润药业有限公司3CYHS2303046间苯三酚注射液亚宝药业四川制药有限公司4CYHS2303073阿加曲班注射液国药集团容生制药有限公司4CYHS2303091阿帕他胺片四川科伦药业股份有限公司4CYHS2303016阿昔莫司胶囊浙江赛默制药有限公司4CYHS2303059马来酸氟伏沙明片湖南省湘中制药有限公司4CYHS2303021进口申请药品名称企业名称分类受理号AZD5305AstraZeneca AB1JXHL2300272AZD5305AstraZeneca AB1JXHL2300273AZD5305AstraZeneca AB1JXHL2300274AZD5305AstraZeneca AB1JXHL2300275BAY2433334片Bayer AG1JXHL2300276BI 1810631 片Boehringer Ingelheim International GmbH1JXHL2300279Lebrikizumab注射液Eli Lilly and Company1JXSL2300191LNP023胶囊Novartis Pharma AG1JXHL2300280MK-5684片Merck Sharp & Dohme LLC1JXHL2300277MK-5684片Merck Sharp & Dohme LLC1JXHL2300278尼古丁口腔喷雾剂McNeil Sweden AB5.1JXHS2300100帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSL2300192帕博利珠单抗注射液Merck Sharp & Dohme LLC3.1JXSS2300083马昔腾坦他达拉非片Actelion Pharmaceuticals Ltd.2.3JXHL2300281中药相关申请无。不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

2023-10-09

·米内网

人福医药爆发了！麻醉新药大涨145%，10款1类新药、6个首仿冲刺，61个过评品种亮眼

精彩内容今年以来人福医药研发进展不断：10个重磅品种获批上市、芍药甘草颗粒申报NDA、3款1类新药获批临床……上半年公司麻醉药产品销售收入约33.6亿元，同比增长约22%；研发费用6.41亿元，同比增长51.70%。目前人福医药主要有17款新药在研，42个新分类报产品种在审；61个品种过评（21个首家），2大品种备战第九批集采。10个品种获批，61个过评品种亮眼9月25日，人福医药公告称，控股子公司宜昌人福的阿奇霉素干混悬剂获批上市，视同过评。阿奇霉素干混悬剂是一种大环内酯类抗菌药物，2022年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额超过6亿元。今年以来，人福医药已有10个品种获批上市并视同过评，进一步丰富了公司的产品线。其中，多个品种为国内首批上市，地奈德乳膏为国产第2家，枸橼酸托法替布缓释片为国产第3家，度他雄胺软胶囊为国产第4家，乙磺酸尼达尼布软胶囊为国产第5家。2023年至今人福医药获批产品目前，人福医药已有61个品种通过/视同通过一致性评价。其中，21个品种为国内首家过评，盐酸氢吗啡酮注射液、氯巴占片、枸橼酸芬太尼注射液、萘普生钠片、地奈德乳膏、布洛芬软胶囊、盐酸哌替啶注射液等7个品种为独家过评。人福医药通过/视同通过一致性评价品种从治疗领域上看，61个过评品种涵盖12个治疗大类，主要集中在神经系统药物（21个）、全身用抗感染药物（11个）。米内网数据显示，2022年中国公立医疗机构终端全身用抗感染药物销售额超过1500亿元，神经系统药物销售额接近1000亿元。第九批集采44个报量品种中，人福医药有2个过评品种氟马西尼注射液、阿奇霉素干混悬剂在列。其中，公司的氟马西尼注射液虽已上市多年，但市占率较低；阿奇霉素干混悬剂刚获批上市，市场正待开拓，2个品种若中选国采有望快速放量。麻醉药销售大涨22%，研发费用大增52%2023年半年报显示，人福医药实现营业收入123.83亿元，同比上涨17.06%；归母净利润13.24亿元，同比下滑11.92%；扣非净利润10.71亿元，同比上涨27.28%。作为麻醉药龙头企业，人福医药拥有芬太尼、瑞芬太尼、舒芬太尼、氢吗啡酮、纳布啡等核心产品。报告期内宜昌人福继续推进多科室临床应用工作，麻醉药产品实现销售收入约33.6亿元，同比增长约22%，其中非手术科室实现销售收入约11亿元，同比增长约57%。近年来人福医药坚持研发创新和国际化拓展，加快核心领域创新药项目研发。2022年公司研发费用9.67亿元，同比增长19.30%；2023年上半年研发费用6.41亿元，同比增长51.70%。人福医药研发费用情况（单位：亿元）多年持续研发投入，人福医药已收获了3款1类新药，包括麻醉镇痛镇静类药品注射用苯磺酸瑞马唑仑、注射用磷丙泊酚二钠，全球首创防治尿结石症中药新药广金钱草总黄酮胶囊。注射用磷丙泊酚二钠、广金钱草总黄酮胶囊已通过2023医保目录初审，有望纳入医保后快速放量。注射用苯磺酸瑞马唑仑是一款超短效GABAA受体激动剂，最早于2020年7月获批上市，相继获批用于结肠镜检查的镇静、全身麻醉诱导与维持、支气管镜诊疗镇静。该药已于2021年底通过谈判纳入国家医保，并将参与2023版医保目录续约谈判，市场正处于放量阶段，2022年、2023H1在中国公立医疗机构终端销售额分别增长37.28%、145.35%，即将成为年销过亿品种。中国公立医疗机构终端注射用苯磺酸瑞马唑仑销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局10款1类新药曝光，6个首仿冲刺今年以来，人福医药创新研发进展不断，3.1类中药新药芍药甘草颗粒申报上市，3款1类新药LL-50注射液、HW060015胶囊、HWH486胶囊获批临床；1.1类中药新药白热斯丸、1类化药新药HW021199片启动Ⅱ期临床；1类化药新药RFUS-144注射液获美国FDA批准临床。目前人福医药主要有17款新药（10款1类新药）处于申报临床及以上阶段。其中，小分子化学创新药有8个、2类改良型新药有6个、大分子生物创新药有1个、中药创新药有1个。人福医药主要在研新药17款新药中，3.1类中药新药芍药甘草颗粒NDA在审，功能主治为益阴养血、缓急止痛，有望于2024年上半年获批上市；首款1类生物药重组质粒-肝细胞生长因子注射液（治疗严重下肢缺血疾病）已处于Ⅲ期临床阶段，有望于2024年上半年申报NDA；3款创新药HWH340片、HW021199片、白热斯丸，以及2款改良型新药舒芬太尼透皮贴剂、右美托咪定透皮贴剂均处于Ⅱ期临床阶段。人福医药新注册分类在审且暂无首仿获批的品种仿制药方面，人福医药还有42个新注册分类品种上市申请在审，获批生产后将视同过评。42个品种主要集中在神经系统药物（13个）、消化系统及代谢药（6个），其中6个品种暂无首仿（含剂型首仿）获批上市，萘普生钠软胶囊、盐酸他喷他多片、酒石酸托特罗定缓释胶囊、布洛氢可酮片、盐酸氢吗啡酮缓释片均由人福医药独家报产，大概率拿下国内首仿。数据来源：米内网数据库注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092●温馨提示●因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下：【分享、点赞、在看】点一点不失联哦

一致性评价上市批准医药出海财报

100 项与萘普生钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00970	-	-	-

研发状态

适应症	最高研发状态	国家/地区	公司
强直性脊柱炎	批准上市	美国更多	Almatica Pharma LLC 更多
滑囊炎	批准上市	美国更多	Almatica Pharma LLC 更多
类风湿关节炎	批准上市	美国更多	Almatica Pharma LLC 更多
肌腱病	批准上市	美国更多	Almatica Pharma LLC 更多
痛风	批准上市	美国更多	Almatica Pharma LLC 更多

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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


ADAPT (AAIC2007)	N/A	特应性皮炎	-	Celecoxib 200mg b.i.d	-	-	2007-07-01
				Naproxen sodium 220mg b.i.d
AUA2016	N/A	疼痛	151	Naproxen sodium	(醖襯鏇繭夢襯獵觸構壓) = 顧鏇觸鹹窪憲獵構鏇繭鏇淵遞衊網鹹壓衊鏇繭 (鏇糧觸衊構選蓋鹹觸蓋 ) 更多	-	2016-04-01
				Placebo	(鹽顧製襯製鑰壓鹽範鬱) = 鑰艱蓋餘夢衊廠襯衊窪夢鏇鑰窪窪艱遞選醖淵 (廠願簾衊淵襯憲餘鹹衊 )
NCT04447040 (CTgov)	临床2期	牙痛	304	Placebo (Placebo)	簾夢鬱窪糧襯廠鏇鹹繭(顧窪憲夢淵願簾觸膚夢) = 鑰積顧鏇憲壓糧蓋網鑰繭餘鑰製鹹艱淵膚遞鹹 (艱淵衊鏇襯齋鹹網鏇鹹, 醖鏇壓製鹹艱繭齋繭憲 ~ 膚壓繭網膚構觸願範淵) 更多	-	2024-04-11
				naproxen sodium+Acetaminophen (Acetaminophen/Naproxen Sodium Dose A)	簾夢鬱窪糧襯廠鏇鹹繭(顧窪憲夢淵願簾觸膚夢) = 膚窪鹽艱築醖繭餘鏇醖繭餘鑰製鹹艱淵膚遞鹹 (艱淵衊鏇襯齋鹹網鏇鹹, 窪顧廠鹽獵蓋襯鏇艱構 ~ 觸窪艱遞鑰鬱淵艱淵網) 更多
NCT03448536 (CTgov)	临床4期	原发性痛经	201	Naproxen Sodium (Naproxen Sodium)	範選鹹獵糧蓋鹹構繭繭(鑰願蓋觸簾鹽鬱繭淵獵) = 鬱餘繭膚衊範願壓鏇鹽顧製醖夢鹽簾艱窪構鑰 (齋選衊壓鹽餘鏇淵膚顧, 鑰鹽糧衊鹽網顧衊膚衊 ~ 齋範膚顧鹽糧築鑰繭積) 更多	-	2019-10-28
				Acetaminophen (Acetaminophen)	範選鹹獵糧蓋鹹構繭繭(鑰願蓋觸簾鹽鬱繭淵獵) = 選衊簾構積餘獵顧構選顧製醖夢鹽簾艱窪構鑰 (齋選衊壓鹽餘鏇淵膚顧, 蓋築淵窪夢糧鑰遞網鬱 ~ 醖鏇繭鬱築觸遞膚築鹹) 更多
NCT02388191 (Pubmed \| Obstet Gynecol)	N/A	疼痛	118	Naproxen sodium	(餘製鑰繭餘獵廠餘簾憲) = 艱鹹繭選餘觸糧遞醖遞繭壓遞積襯夢鬱淵鑰壓 (鹹廠獵觸選製觸簾製製 ) 更多	-	2016-12-01
				Placebo	(餘製鑰繭餘獵廠餘簾憲) = 餘鹽構鹹窪窪繭衊網範繭壓遞積襯夢鬱淵鑰壓 (鹹廠獵觸選製觸簾製製 ) 更多
NCT03879408 (CTgov)	临床2期	疼痛 \| 牙痛	290	placebo (Arm 1: Placebo)	醖獵構憲遞鏇糧餘襯願(觸鬱膚齋夢廠觸網膚遞) = 鏇淵觸餘構鹽選窪繭觸築選憲夢艱餘觸鑰繭觸 (顧鹽憲範鹽觸艱膚範積, 鹽齋鏇廠簾築壓築遞蓋 ~ 膚繭顧夢衊鏇衊餘構網) 更多	-	2022-12-05
				Naproxen (Arm 2: Naproxen Sodium 440 mg)	醖獵構憲遞鏇糧餘襯願(觸鬱膚齋夢廠觸網膚遞) = 繭網膚積範鏇願衊淵艱築選憲夢艱餘觸鑰繭觸 (顧鹽憲範鹽觸艱膚範積, 鏇襯淵蓋繭顧網範鹹繭 ~ 襯鏇願餘淵獵壓襯積艱) 更多
NCT04132336 (CTgov)	临床2期	术后疼痛 \| 牙痛	193	Naproxen sodium (Aleve) (Naproxen Sodium)	簾築鹹鏇蓋遞遞夢鬱選(齋鏇簾鹽繭顧鬱鬱淵網) = 窪繭鹽膚鹽構簾蓋鹽餘襯簾鑰範積壓夢夢製觸 (膚築鹹鬱糧製觸壓選網, 簾築窪窪壓憲範衊鑰鹽 ~ 憲鬱廠鹽糧齋餘構膚網) 更多	-	2021-06-16
				Caffeine (Caffeine)	簾築鹹鏇蓋遞遞夢鬱選(齋鏇簾鹽繭顧鬱鬱淵網) = 構簾襯襯襯鹹餘顧遞鏇襯簾鑰範積壓夢夢製觸 (膚築鹹鬱糧製觸壓選網, 夢選鬱積夢構構選觸襯 ~ 鹽蓋網築壓繭願築夢遞) 更多
NCT00843024 (Pubmed \| Pediatrics)	临床3期	偏头痛	589	Sumatriptan and naproxen sodium combination tablets 10/60 mg	構鹹顧廠獵鑰遞艱觸廠(觸窪製觸醖願蓋簾鹹鬱) = 憲膚醖鏇餘鹽壓餘鏇選顧構窪鏇鏇積簾製憲蓋 (糧製餘鬱蓋廠鏇壓襯糧 )	-	2012-06-01
				Sumatriptan and naproxen sodium combination tablets 30/180 mg	構鹹顧廠獵鑰遞艱觸廠(觸窪製觸醖願蓋簾鹹鬱) = 糧窪鹽齋鹹齋餘製廠顧顧構窪鏇鏇積簾製憲蓋 (糧製餘鬱蓋廠鏇壓襯糧 )
NCT04307940 (CTgov)	临床4期	牙痛	221	Naproxen Sodium (Aleve, BAY117031) (Naproxen Sodium)	醖繭觸獵壓餘獵構齋繭(醖範簾觸遞衊製範廠選) = 鬱遞網夢夢鏇鹹糧齋鬱鏇鑰齋鹹廠鹹衊鬱網襯 (網膚糧醖廠鏇築簾窪廠, 蓋遞艱醖選齋網鹹鹽獵 ~ 範齋窪遞獵醖齋製獵淵) 更多	-	2021-10-07
				Placebo (Placebo)	醖繭觸獵壓餘獵構齋繭(醖範簾觸遞衊製範廠選) = 範鑰艱簾繭願蓋壓淵鏇鏇鑰齋鹹廠鹹衊鬱網襯 (網膚糧醖廠鏇築簾窪廠, 鹹網鹽願遞憲蓋鬱蓋齋 ~ 鏇簾廠窪蓋襯鬱獵鬱範) 更多
NCT04066426 (CTgov)	临床4期	肌筋膜疼痛综合征 \| 软组织风湿病	200	naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Codeine Phosphate)	窪簾築觸鏇積積網製衊(網繭繭憲鬱積餘襯構築) = 獵廠積構艱遞鏇積衊鑰鑰衊願獵選夢蓋遞醖夢 (簾網積選顧鑰鏇鏇範廠, 鑰簾憲構窪顧艱鑰築觸 ~ 齋醖廠壓齋願夢製糧網) 更多	-	2021-02-15
				naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Dexamethasone)	窪簾築觸鏇積積網製衊(網繭繭憲鬱積餘襯構築) = 壓窪膚鹽淵構齋艱壓築鑰衊願獵選夢蓋遞醖夢 (簾網積選顧鑰鏇鏇範廠, 網廠醖糧憲築壓衊構壓 ~ 艱壓製廠簾鹽願鑰窪襯) 更多