Many patients with Postural Orthostatic Tachycardia Syndrome (POTS) experience debilitating fatigue and this significantly impacts their daily lives. Unfortunately, there are no treatments to help POTS patients with their fatigue. One medication, called low dose naltrexone (LDN), has been tested as a treatment for fatigue in other medical conditions. In this other research, LDN helped patients feel less fatigue. Other research studies have shown that LDN can help reduce markers of inflammation called cytokines. Reducing these cytokines could help reduce symptoms as well. There have been no research studies testing LDN in POTS to date. We are planning to do a research study to test LDN as a treatment to see if it helps POTS patients feel less fatigue.

开始日期2025-01-01

申办/合作机构

University of Calgary

NCT05382091 / Not yet recruiting临床2期

A Phase II Multi-Center Safety Study Examining the Use of the O'Neil Long Acting Naltrexone Implant (OLANI) in Opioid Dependent Persons Receiving Repeat Dosing

This study will examine the safety and efficacy of the O'Neil Long Acting Naltrexone Implant (OLANI) in persons with opioid dependency who are seeking relapse-prevention treatment. All participants will be treated in an open label manner. No randomization will occur. The OLANI is a long-acting biodegradable form of naltrexone which is implanted in the abdominal region. It is hypothesized that the OLANI will produce blood levels sufficient to block the effects of opioids for an extended period allowing patients to engage in psychosocial treatment and recovery over the long term. After the initial set of implants, participants will be offered a second set of implants after 13-24 weeks.

开始日期2024-10-15

申办/合作机构

Go Medical Industries Pty Ltd.

[+5]

NCT06306157 / Recruiting临床4期IIT

Low Dose Naltrexone (LDN) Therapy for Complex Regional Pain Syndrome (CRPS): A Feasibility Study

Complex Regional Pain Syndrome (CRPS) is a rare and often debilitating chronic pain condition whereby individuals may experience extreme sensitivity, discoloration, and swelling of the affected area -- along with numerous other painful symptoms. There are currently a limited number of treatment options available to those suffering with the condition, with various treatments including nerve blocks, neuropathic medications, and desensitization physical therapy modules. There is budding interesting in the role naltrexone, an opiate antagonist, may play in the pain management of CRPS when prescribed in very low doses. This study aims to collect preliminary data on pain scores, symptom severity, and side-effects in patients with Complex Regional Pain Syndrome randomized to receive low dose naltrexone or placebo capsules. Enrollment of 40 patients total will occur over two years from study start to study end. Each patient will be randomized to receive placebo capsules or active low dose naltrexone capsules, with both the patient and treating clinician blind to the randomization. Each patient will be actively enrolled in the study for six months and will take the medication daily at the instructed dose for the respective duration of time. Following the initial visit and study enrollment, the investigators are asking each patient to return for three (3) in-person follow-up office visits. These office visits will occur 1 month after the patient starts the medication, 3 months afterwards, and 6 months afterwards. The final 6-month office visit will mark the conclusion of the patient's active participation in the study.

开始日期2024-08-01

申办/合作机构

Hospital for Special Surgery

100 项与盐酸纳曲酮相关的临床结果

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100 项与盐酸纳曲酮相关的转化医学

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100 项与盐酸纳曲酮相关的专利（医药）

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696

项与盐酸纳曲酮相关的文献（医药）

2024-10-01·DRUG AND ALCOHOL DEPENDENCE

The cascade of care for commercially-insured persons with opioid use disorder and comorbid HIV and HCV infections

Article

作者: Ahmad, Bachar ; Ram, A ; Oliveros, David ; Madden, Lynn M ; DiDomizio, Elizabeth ; Ivasiy, Roman ; Altice, Frederick L ; Johnson, Kimberly A ; Machavariani, Eteri ; Kil, Natalie

BACKGROUND:

Opioid use disorder (OUD) significantly impacts individual and public health and exacerbated further by concurrent infectious diseases. A syndemic approach is needed to address the intertwined OUD, HIV, and HCV epidemics, including the expanded use of medications for opioid use disorder (MOUD).

METHODS:

To identify MOUD scale-up opportunities, we conducted a retrospective cohort study, representing commercially insured persons, and created the OUD care continuum, including HIV and HCV influences in adults (18-64 years) newly diagnosed with OUD in 2019 using Merative MarketSan data.

RESULTS:

Among 124,467,633 individuals, the prevalence of OUD was 0.4 % (95 % CI: 0.36 %-0.46 %; N = 497,871), with 327,277 (65.7 %, 95 % CI: 65.60 %-65.87 %) newly diagnosed in 2019. Among these newly diagnosed individuals (54 % men, mean age 44±0.01), 53,568 (27.0 %, 95 % CI: 26.4 %-27.5 %) were prescribed MOUD, with retention rates at 1, 3, and 6 months being 89.0 % (95 % CI: 88.2 %-89.8 %), 66.0 % (95 % CI: 64.8 %-67.2 %), and 50.3 % (95 % CI: 48.3 %-51.6 %), respectively. Buprenorphine was the most prescribed MOUD (79.6 %, 95 % CI: 78.6 %-80.7 %), followed by XR-NTX (14.9 %, 95 % CI:14.0 %-15.8 %) and methadone (5.5 %, 95 % CI: 4.9 %-6.1 %). Six-month retention was highest for methadone (73.4 %, 95 % CI: 73.0 %-73.8 %), however, followed by buprenorphine (55.7 %, 95 % CI: 55.3 %-57.1 %) and substantially lower for XR-NTX (12.6 %, 95 % CI: 10.6 %-14.6 %). Screening for HIV and HCV was low among OUD enrollees (11.1 %, 14.4 %), slightly higher for MOUD initiators (18.0 %, 21.6 %). Being prescribed MOUD was correlated with HCV infection (AOR: 2.54; 95 % CI: 2.41-2.68), HCV/HIV coinfection (AOR: 1.89; 95 % CI: 1.41-2.53), and hospitalization for OUD-related services (AOR: 1.14; 95 % CI: 1.11-1.17), yet hospitalization for OUD-related services was positively correlated with XR-NTX (AOR: 2.72; 95 % CI: 2.56-2.85) prescription and negatively with methadone (AOR: 0.19; 95 % CI: 0.16-0.23) prescription. Having HIV was negatively correlated with being prescribed methadone (AOR: 0.33; 95 % CI: 0.13-0.86).

CONCLUSIONS:

Substantial gaps in the OUD cascade persist, underscoring better implementation opportunities for MOUD prescription in hospital-based settings and expanding access to methadone beyond highly regulated sites given its low coverage yet high treatment retention.

2024-09-23·BMC Chemistry

An eco-friendly smartphone based HPTLC method versus conventional densitometric one for determination of Naltrexone and Bupropion.

Article

作者: Fayed, Ahmed S ; Abdel-Moety, Ezzat M ; Moaaz, Eman M ; Rezk, Mamdouh R

The rapid uprising technologies of smartphone applications and software introduced a new era for analytical detection techniques. It has transformed bench-top laboratory methods into simpler ones depending on cost-effective, portable, and widely accessible devices. In this work, two high performance thin layer chromatographic (HPTLC) methods were developed based on smartphone's camera detection and either ImageJ desktop software or Color-Picker smartphone's application as alternative techniques to conventional densitometric detection. A mixture of Naltrexone hydrochloride (NAL) and Bupropion hydrochloride (BUP) was chromatographed on HPTLC- plates using ethyl acetate, methanol, acetone, and glacial acetic acid (3:6:1:0.5, by volume) as a developing system. The developed plates were scanned at 203 nm for the densitometric analysis, then visualized by modified Dragendorff's reagent and shot by a smartphone's camera. The captured images were uploaded to either ImageJ software or Color-Picker application to detect the separated spots. The results derived from the three detection methods were compared over the concentration range of 0.4-24 & 0.6-18 µg/band for the densitometric method, 0.4-24 & 2-24 µg/band for ImageJ built method and 0.8-20 & 5-20 µg/band for Color Picker built method for NAL and BUP, respectively. The methods were found to be appropriate for assaying both active drug substances in pure forms and combined in marketed pharmaceutical formulations. The excellent sustainability of densitometric and ImageJ-based methods enabled also the assessment of their dosage form content uniformity. The greenness and sustainability of the methods were assessed by three metric tools, namely Green Analytical Procedure Index (GAPI), Analytical GREEnness Metric Approach (AGREE), and White Analytical Chemistry (WAC). The assessments results confirmed the sustainability and superiority of the proposed methods in terms of sample treatment, waste mount, energy consumption, cost, and number of analyzed samples per an hour.

2024-09-01·Journal of substance use and addiction treatment

Buprenorphine-naloxone vs. extended-release naltrexone for opioid use disorder in individuals with and without criminal legal involvement: A secondary analysis of the X:BOT randomized controlled trial

Article

作者: Puglisi, Lisa B ; Balter, Dylan Rose ; Fiellin, David A ; Howell, Benjamin A ; Dziura, James

INTRODUCTION:

There is uncertainty about whether criminal legal involvement (CLI) impacts the effectiveness of medications for opioid use disorder (MOUD). We aimed to determine whether CLI modifies the association between buprenorphine-naloxone (BUP-NX) vs. extended-release naltrexone (XR-NTX) and MOUD treatment outcomes.

METHODS:

We conducted a secondary analysis of X:BOT, a 24-week multi-center randomized controlled trial comparing treatment outcomes between BUP-NX (n = 287) and XR-NTX (n = 283) in the general population. We used baseline Additional Severity-Index Lite responses to identify patients with recent CLI (n = 342), defined as active CLI and/or CLI in the past 30 days, and lifetime incarceration (n = 328). We explored recent CLI and lifetime incarceration as potential effect modifiers of BUP-NX vs. XR-NTX effectiveness on relapse, induction, and overdose. We conducted both intention-to-treat and per-protocol analyses for each outcome.

RESULTS:

In intention-to-treat analyses, recent CLI modified the effect of BUP-NX vs. XR-NTX on odds of successful induction (p = 0.03) and hazard of overdose (p = 0.04), but it did not modify the effect on hazard of relapse (p = 0.23). All participants experienced lower odds of successful induction with XR-NTX compared to BUP-NX, but the relative likelihood of successful induction with BUP-NX was lower than XR-NTX among individuals with recent CLI (OR: 0.25, 95 % CI: 0.13-0.47, p < 0.001) compared to those without recent CLI (OR: 0.04, 95 % CI: 0.01-0.19, p < 0.001). Participants with recent CLI experienced similar hazard of overdose with XR-NTX and BUP-NX (HR: 1.12, 95 % CI: 0.42-3.01, p = 0.82), whereas those without recent CLI experienced greater hazard of overdose with XR-NTX compared to BUP-NX (HR: 12.60, 95 % CI: 1.62-98.03, p = 0.02). In per-protocol analyses, recent CLI did not modify the effect of MOUD on hazard of overdose (p = 0.10) or relapse (p = 0.41). Lifetime incarceration did not modify any outcome.

CONCLUSIONS:

Compared to individuals without recent CLI, individuals with recent CLI experienced decreased relative effectiveness of BUP-NX compared to XR-NTX for induction and overdose outcomes. This highlights the importance of considering the impact of recent CLI on opioid use disorder treatment outcomes. Future research should explore the mechanisms through which recent CLI modifies MOUD effectiveness and aim to improve MOUD effectiveness for individuals with recent CLI.

项与盐酸纳曲酮相关的新闻（医药）

2024-09-28

·米内网

知名医院摊上事了！25个药品价格“跳水”，医药大省集采结果出炉，恒瑞、君实1类新药亮眼

看点 view 本周，2024上半年医药工业统计数据出炉，中纪委点名医院招标腐败，知名医院涉骗保遭严查；药品市场迎变局，447个产品拟中选医药大省集采，25个品种主动降价，29款国谈药医保支付价公开；企业大新闻，两大国资药企“牵手”推动中医药现代化，一创新药企业闯关IPO折戟，恒瑞医药、君实生物1类新药亮眼......医药行业一周大事件，精彩不容错过！米内一周TOP榜米内数据口服高血压药TOP20，施慧达、华润双鹤突围 23个独家品种厉害了！扬子江2大品种亮眼软膏剂TOP20洗牌，华润三九、华邦上榜药企动态倍特拿下25个重磅品种，126个过评品种霸屏奥赛康首仿药大涨454%，5款重磅新品获批石药发力改良型新药，超600亿市场起波澜审评药闻海思科1类新药来袭！抢攻1400亿市场 5亿畅销产品，石四药入局抢食 9亿大品种，浙江药企获批了覆盖全国18省！“六病共管”集采蓄势待发 9月24日，三明采购联盟第六次联席会议暨开展“六病共管”用药（第一批）集采工作会议在福建省三明市召开，会议指出：“六病共管”用药集采被列入国家招采重点工作；鼓励集采药品落地向民营医疗机构、零售药店和村卫生室延伸；大力推进集采药品追溯码工作，遏制医保药品“回流”、“重复销售”等违规行为；黑龙江全省加入三明采购联盟等。截至目前，三明采购联盟成员已覆盖全国18个省份、42个地级市、4个全国医改示范县，覆盖区域人口逾1.8亿人。（三明采购联盟）延伸阅读： “六病共管”是三明市与上海瑞金医院的深度合作管理模式，该项目以三明医改为背景，依托瑞金医院的优质资源，从人出生到死亡的全生命周期中，选取肿瘤、心脑血管、呼吸、代谢、生殖医学以及老年医学六类高发病率疾病，由瑞金医院和三明市医疗机构共同对患者进行诊疗和管理。“六病共管”项目于今年2月正式启动，目前瑞金医院已与三明市10余家总医院开展协作。中纪委再发文，点名医院招标腐败 9月26日，中央纪委国家监委发布题为《深度关注|营造风清气正招投标环境》的头条文章，其中提到，部分省（市）公共资源交易中心场所管理不严、现场监督不实、交易秩序混乱，有的评标专家在评标过程中肆无忌惮，频繁违法。比如：江苏省公共资源交易中心工作人员腐败窝案中，某开评标现场管理人员利用职务便利，经常随意进出招投标现场，并通过暗示评标专家、泄露答辩题目、向投标企业提供评标专家名单、协助将项目运作到省平台交易等方式帮助企业中标，受贿共计690余万元。今年以来，中纪委围绕招投标腐败问题密集发文，其中评标专家管理被多次点名。（中央纪委国家监委） 2024上半年医药工业发展“遇冷”，子行业表现各异 9月26日，中国医药企业管理协会披露《2024年上半年医药工业经济运行情况》，2024上半年，我国规模以上医药工业增加值同比增长1.2%；规模以上企业实现营业收入14465.5亿元，同比下降1.4%；实现利润2111.2亿元，同比下降1.2%。分子行业看，化学原料药和化学制剂营业收入小幅下降，但利润实现了正增长，分别为+8.2%和+5.7%；中药饮片是唯一营收（+6.1%）、利润（+2.8%）均实现正增长的子行业；生物制品摆脱了新冠疫苗影响因素，营业收入恢复正增长（+0.7%）；中成药、卫生材料及医药用品、医疗仪器设备及器械、制药专用设备等4个子行业营收和利润均为负增长。（中国医药企业管理协会） 5款独家中成药申请保护获准 9月24日，国家药监局发布公告称，对5款独家中成药给予二级保护，其中，批准贵州汉方药业的芪胶升白胶囊、山东凤凰制药的复方川芎片、重庆华森制药的六味安神胶囊、哈尔滨市康隆药业的炎宁糖浆为首家中药二级保护品种，对青岛华仁太医药业的蒲元和胃胶囊延长二级保护期。（国家药监局）本周获批中药二级保护的品种两大国资药企“牵手”，推进中医药现代化 9月23日，重药控股官方微信公众号发布消息，由华润三九（华润医药子公司）和重庆医药（重药控股子公司）共同出资组建的重庆医药集团九隆现代中药有限公司（下文简称“重药九隆”）正式开业投产，主营业务包括中药配方颗粒、中药饮片、中药材以及中成药生产等。重药九隆成立于2020年10月，项目于2022年5月开工建设，总投资约4亿元，目前由华润三九持股51%，重庆医药持股49%。（企业官微）延伸阅读：今年6月，经过股权无偿划转后，重药控股间接控股股东变更为通用技术集团，实际控制人变更为国资委，其与华润三九的合作可以视为一次国资“牵手”。 447个产品拟中选！医药大省集采结果出炉 9月27日，福建省医保局发布《福建省第五批药品集中带量采购公告（第7号）》，对本省第五批药品集采拟中选清单进行公示，公示时间为9月28日至10月10日。据悉，本次集采共有447个产品拟中选，其中，接续采购产品有129个，新一轮采购产品有318个。经对比，接续采购目录中的西尼地平口服常释剂型、美洛西林舒巴坦(4:1)注射剂，及新一轮采购目录中的氟比洛芬贴剂、青霉素注射剂拟流标。（福建省医保局）狙击超200亿市场，恒瑞1类新药临床报喜 9月24日、26日，恒瑞医药连发两则公告称，旗下1类新药HRS-2129片、3类仿制药氟[18F]美他酚注射液获批临床。其中，HRS-2129片拟用于治疗急慢性疼痛，目前国内外尚无同类产品获批上市，米内网数据显示，2023年中国三大终端六大市场（统计范围详见本文末）止痛药销售规模首破200亿元，同比涨逾8%。氟[18F]美他酚注射液是一款放射性诊断剂，拟用于评估阿尔茨海默病或其他原因导致的认知障碍的成年患者脑内β-淀粉样蛋白聚集形成的神经炎斑密度的PET成像。（米内网整理） 29个国谈药，医保支付标准公开 9月23日，山西省药械集采网发布《关于对2023年国谈药品（竞价药品）同通用名药品（第二批）医保支付标准进行公示的函》，拟公开29个国谈药医保支付标准，不乏沙库巴曲缬沙坦钠片、注射用头孢他啶阿维巴坦钠、复方氨基酸注射液(14AA-SF)等2023年在中国三大终端六大市场销售额超10亿元的大品种。按品规及最小包装数量统计，正大天晴药业、齐鲁制药、海南广升誉制药等均有3个及以上产品在列。（山西省药械集采网）最高88%！25个品种主动降价 9月23日，河南省医药集中采购平台发布了一则下调药品价格公示。据梳理，此次共有20家企业、25个药品提交了降价申请，医保品种占比超过八成。其中，丙酚替诺福韦片剂、法舒地尔注射剂等品种降幅较大，均超过70%，而成都国为医药的纳美芬注射剂价格仅下降0.003%，为本次降幅最小的产品。（米内网整理）超11亿大品种！君实1类新药再下一城 9月25日，君实生物发布公告称，公司自主研发的1类新药特瑞普利单抗于近日获欧盟委员会批准上市，用于转移性鼻咽癌（NPC）一线治疗，及晚期/复发或转移性食管鳞癌（ESCC）一线治疗。此前，特瑞普利单抗已先后于2018年和2023年在中国、美国等地获批上市。（公司公告）米内数据：特瑞普利单抗是国内首个获批上市的国产PD-1单抗，2020年通过谈判进入医保后市场实现快速放量，2023年在中国三大终端六大市场销售额超过11亿元，同比增长37.11%。采购不合规！一医药企业被罚157万 9月25日，重庆市药监局公开的一则行政处罚决定书中显示，益百家医药（重庆）有限公司未从药品上市许可持有人或者具有药品生产、经营资格的企业购进强骨生血口服液、复方木芙蓉涂鼻软膏、射干利咽口服液，依据《中华人民共和国药品管理法》相关规定，重庆市药监局依法对其作出没收违射干利咽口服液16681盒、强骨生血口服液1809盒、复方木芙蓉涂鼻软膏186盒，罚款合计约157万元等行政处罚。（重庆市药监局）原拟募13亿元！善康医药闯关IPO折戟 9月24日，上海证券交易所官网显示，深圳善康医药科技股份有限公司（下文简称“善康医药”）主动撤回科创板上市申请，IPO终止。据悉，善康医药主要从事以预防阿片类毒品复吸、治疗酒精使用障碍为代表的成瘾治疗药物等创新药的研发、生产和销售。今年6月，公司的核心产品盐酸纳曲酮植入剂（2.2类新药）获批上市，用于预防阿片类物质依赖患者脱毒后的复吸，有效时长达150天，是国内目前唯一一款进入商业化阶段的长效戒毒药物。（中国经济网）延伸阅读：善康医药原计划选择“科创板第五套”标准上市，即“预计市值不低于40亿元，主要业务或产品需经国家有关部门批准，医药企业需至少有一项核心产品获准开展Ⅱ期临床等相关条件”。公司此次原拟募资13.27亿元，用于新药研发项目、创新药高端制剂生产基地建设项目、营销网络建设项目、补充流动资金项目等。知名医院出事了！法人、院长等被采取刑事措施 9月24日，无锡市医保局发布情况通报称，近日，无锡市医保局会同公安、卫健委等部门继续对无锡虹桥医院涉嫌骗取医保问题进行全面调查，目前该医院骗保情况基本查实。9月22日，无锡市医保局取消其医保定点资格，公安机关刑事立案。9月23日，无锡虹桥医院法定代表人、院长等15名涉案人员已被公安机关依法采取刑事强制措施。该民营医院现已停业。（无锡市医保局）注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。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 【分享、点赞、在看】点一点不失联哦

带量采购IPO

2024-09-26

·药渡

又一家未盈利Biotech的科创板IPO，黄了

2024年9月24日，深圳善康医药科技股份有限公司(简称：善康医药)的IPO审核状态变更为终止。上交所主页信息显示：因善康医药及其保荐人撤回发行上市申请，上交所终止其发行上市审核。作为一家既无产品上市，也没有任何盈利的创新药企业，善康医药采用的是难度最大的科创板第五套上市标准，即所谓的“标准五”。今年到目前为止，尚未有一家未盈利的创新药企业顺利通过“标准五”登陆科创板，但是像善康医药这样半途折戟沉沙的比比皆是。从药品应用方向来说，善康医药的核心在研产品略显小众和另类。招股书显示，善康医药主要从事以预防阿片类毒品复吸、治疗酒精使用障碍为代表的成瘾治疗药物等创新药的研发、生产和销售，是一家拥有自主知识产权和全球视野的国际化创新药研发企业，致力于打造成瘾治疗的“中国方案”。从管线数量来说，善康医药的管线阵容略显单薄。截至招股说明书签署日，善康医药产品管线中有1个核心产品的2个适应症分别处于产品注册申请准备阶段和Ⅱ期临床阶段，并拥有6个主要临床前在研项目。也就是说，这是一家凭借一款核心管线就敢冲刺科创板IPO的企业，在前两年上市标准较为宽松的时期，或许还有几分胜算，但是不巧一头撞到了医药企业IPO的寒冰期，这个结局也是在所难免。用于预防阿片类物质成瘾患者脱毒后的复吸的SK1801“纳曲酮植入剂”，是公司的核心研发产品，该品种已完成II期临床试验，并经CDE初步同意豁免III期临床试验，在2023年2月6日，该产品的NDA申请正式被受理。这是国内唯一一款接近进入商业化阶段的长效戒毒药物，上市后将填补国内长效戒毒药物市场空白。但是有点尴尬的是，在国内市场，这款药物的适用群体正在快速萎缩。公开披露信息显示，纳曲酮植入剂在戒毒领域的患者对象为阿片类毒品依赖人群，而由于社会治理与预防水平的不断提升，国内阿片类毒品成瘾人数从2015年的98万人，下降至2021年的55.6万人，6年时间就接近腰斩。对此，善康医药表示，经测算，国内销售峰值对应的治疗病人数量为7.3万人左右，即使考虑公司纳曲酮植入剂因疗效较好可能导致存量患者数量进一步减少的情况下，上述患者数量，仍能保证公司产品未来的市场空间。此外，竞品角度来说，纳曲酮这个产品，除了植入剂以外，目前还有其他剂型的产品也在上市。 2024年9月13日，北京华素制药股份有限公司收到国家药品监督管理局签发的《受理通知书》，其盐酸纳曲酮片（规格：50mg）一致性评价申请获得受理。公开信息显示，盐酸纳曲酮片可阻断外源性阿片类物质的药理作用，作为酒精依赖脱瘾和阿片类依赖者脱毒后预防复吸的辅助药物。虽然植入剂型确实具备自身的各种优点，但是片剂具备价格优势，因此植入剂型最终能在市场中占据多大的比例，尚有一定的不确定性。根据此前的计划，善康医药拟募资13.27亿元，发行预计市值为52.84亿元。内容来源：医药投资部落药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

IPO临床3期临床2期

2024-09-12

·GlobeNewswire-Health Care

Scilex Holding Company Announces It Has Received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®)

PALO ALTO, Calif., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it has received the Drug Distributor Accreditation from the National Association of Boards of Pharmacy® (NABP®). Scilex has satisfied all the drug distributor criteria set in place by the NABP. The NABP® is a 501(c)(3) nonprofit organization founded in 1904. Working with their members – the state boards of pharmacy – they help support patient and prescription drug safety, through examinations that assess pharmacist competency, pharmacist licensure transfer and verification services, and various pharmacy accreditation programs. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, refer to www.semnurpharma.com For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022. Scilex Holding Company is headquartered in Palo Alto, California. Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s long-term objectives and commercialization plans, future opportunities for Scilex, Scilex’s future business strategies and Scilex’s current and prospective product candidates. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to Scilex Holding Company to use the registered trademark. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2024 Scilex Holding Company All Rights Reserved.

快速通道上市批准临床3期临床2期引进/卖出

100 项与盐酸纳曲酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02095	盐酸纳曲酮	N07BB04	DB00704

研发状态

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适应症	国家/地区	公司	日期
酒精使用障碍	中国	深圳善康医药科技股份有限公司	2024-06-25
酗酒	美国	Teva Women's Health, Inc.	1984-11-20
阿片相关性障碍	美国	Teva Women's Health, Inc.	1984-11-20

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
鸦片依赖	临床2期	中国	湖南赛沃药业有限公司	2018-12-24
鸦片依赖	临床2期	中国	湖南省中医药研究院	2018-12-24
新型冠状病毒感染	临床1期	美国	Statera Biopharma, Inc.	2021-12-05

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临床结果

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分期

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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


NCT03447743 (CTgov)	早期临床1期	阿片滥用 \| 鸦片依赖	9	XR-NTX community location	選襯淵艱廠鏇構憲鏇夢(醖顧艱鬱廠壓鬱範糧鏇) = 襯獵鑰願憲蓋繭鹽鹹鑰選觸顧遞糧淵繭選壓醖 (製鬱醖顧壓壓淵鑰膚範, 窪顧選構鏇衊淵構築壓 ~ 窪獵廠願齋淵觸獵蓋範) 更多	-	2023-03-27
AAD2023	N/A	Brocq假性斑秃	46	Low-dose oral naltrexone	遞選廠壓餘淵觸齋蓋範(齋廠窪鏇獵衊築簾鑰積) = Side effects were reported by 21.7% of patients and included insomnia, vivid dreams, and gastrointestinal upset. 夢構願餘顧淵顧觸構醖 (築餘鑰鑰鬱憲範齋壓膚 )	-	2023-03-17
NCT04052139 (UH3, CTgov)	临床2期	酒精使用障碍 \| 炎症 \| HIV感染 ... 更多	45	Low-dose naltrexone (Low-dose Naltrexone)	糧鑰糧構積鬱構廠膚繭(蓋鏇廠衊鏇築築簾鹹艱) = 憲獵廠廠選築齋鏇顧鏇願觸壓鏇製遞構餘鑰襯 (廠餘鹹糧壓遞醖製構獵, 廠餘淵壓壓繭製糧鑰襯 ~ 選襯鑰遞齋窪窪廠鹹構) 更多	-	2022-11-10
				Gabapentin (Gabapentin)	糧鑰糧構積鬱構廠膚繭(蓋鏇廠衊鏇築築簾鹹艱) = 顧壓鬱憲獵願鹹鏇鑰齋願觸壓鏇製遞構餘鑰襯 (廠餘鹹糧壓遞醖製構獵, 艱齋齋獵遞夢選壓窪鑰 ~ 網製窪築觸鹽齋衊遞簾) 更多
Pubmed	N/A	酒精使用障碍	-	Extended-Release Naltrexone and Case Management	齋繭餘鹽觸襯鹽構選鹽(鑰蓋積範齋網蓋網範網) = 糧顧憲製觸築蓋範壓蓋壓鑰夢淵夢簾鑰網鹽遞 (遞簾蓋範醖鹽範網選壓 ) 更多	-	2022-10-31
NCT03810495 (CTgov)	临床1期	阿片滥用	20	naltrexone implant	夢構顧築憲艱襯醖製淵(製獵鬱顧鏇製築鏇築淵) = 窪構廠鹽壓簾獵鏇憲鹹繭齋範鬱廠顧繭積憲鹽 (齋鹽醖製鹹糧膚壓構鑰, 簾夢齋遞艱遞齋顧積壓 ~ 艱蓋鏇膚醖夢衊壓顧製) 更多	-	2022-08-01
NCT02543944 (GBN, CTgov)	临床2/3期	未指明的药物依赖	117	Naltrexone (depot)+Buprenorphine+Clonidine+Gabapentin+Naltrexone (oral) (Gabapentin)	簾鏇膚窪衊鏇齋顧艱醖(鏇衊範膚鹹鬱糧淵鏇齋) = 鹹衊憲壓鑰選鏇憲憲鏇網齋觸範糧淵壓醖艱築 (膚鬱蓋衊鹹憲鹹範範夢, 鑰襯壓鏇構構製遞鑰鹹 ~ 範壓觸壓製廠鑰鏇積鑰) 更多	-	2022-07-28
				Placebo+Naltrexone (depot)+Buprenorphine+Clonidine+Naltrexone (oral) (Placebo)	簾鏇膚窪衊鏇齋顧艱醖(鏇衊範膚鹹鬱糧淵鏇齋) = 淵願網願觸糧願鏇鑰鹽網齋觸範糧淵壓醖艱築 (膚鬱蓋衊鹹憲鹹範範夢, 願艱醖憲鹹壓糧廠築顧 ~ 衊窪廠齋艱廠壓醖獵淵) 更多
NCT04409041 (CTgov)	临床2期	毛发扁平苔癣 \| FFA	43	Low-Dose Naltrexone	鏇鏇繭鑰鹹鬱艱鹹蓋夢(窪鹽夢醖繭築餘顧鑰網) = 鑰選夢衊簾範構簾夢襯憲壓選襯願獵廠壓醖醖 (願製願顧蓋網淵鹹醖鹽, 窪齋選簾壓淵糧鏇餘餘 ~ 憲顧廠窪膚顧鬱築壓艱) 更多	-	2021-12-30
NCT01843023 (CTgov)	临床4期	阿片滥用 \| 未指明的药物依赖	288	Psychosocial Treatment+Extended Release Naltrexone (Extended Release Naltrexone)	積網範獵繭積範觸鏇壓(襯窪網製簾鹹構選鏇觸) = 艱醖簾淵網窪壓網願獵衊觸製簾積顧構遞膚襯 (簾製鹽衊獵網繭網淵製, 衊範齋選壓壓壓淵廠襯 ~ 壓選蓋憲觸製蓋繭範蓋) 更多	-	2021-11-10
				Psychosocial Treatment+Buprenorphine (Treatment as Usual)	積網範獵繭積範觸鏇壓(襯窪網製簾鹹構選鏇觸) = 鹽網醖網願觸衊夢衊願衊觸製簾積顧構遞膚襯 (簾製鹽衊獵網繭網淵製, 鏇簾蓋鏇積鏇獵選齋積 ~ 醖網鹽繭選窪網鹹積獵) 更多
NCT01402492 (CURB, CTgov)	临床2/3期	可卡因相关疾病	302	Naltrexone+Buprenorphine (BUP4+XR-NTX)	醖築鹽衊範構壓窪鬱鏇(齋觸網簾廠窪簾衊獵醖) = 餘襯選膚艱獵餘糧鏇鹹獵鏇壓艱積獵鑰壓鬱選 (網鑰獵願觸鹹築醖鏇顧, 鏇餘餘醖構築鑰選構廠 ~ 簾壓觸選膚艱鹹顧壓網) 更多	-	2021-10-29
				Naltrexone+Buprenorphine (BUP16+XR-NTX)	醖築鹽衊範構壓窪鬱鏇(齋觸網簾廠窪簾衊獵醖) = 獵鑰範鏇窪製觸淵繭膚獵鏇壓艱積獵鑰壓鬱選 (網鑰獵願觸鹹築醖鏇顧, 齋選壓獵願繭憲繭範醖 ~ 餘窪糧網鏇製獵壓衊夢) 更多
NCT01717963 (Pubmed \| Am J Addict)	临床3期	阿片滥用一线	143	Extended-Release Naltrexone (XR-NTX)	廠遞鬱窪醖選醖淵遞繭(構襯齋鏇鬱糧憲願廠壓): HR = 0.46 (95% CI, 0.28 ~ 0.76)	积极	2021-09-01
				Buprenorphine-Naloxone (BP-NLX)