Nalbuphine Hydrochloride

作者 | 陈芋 来源 | 赛柏蓝 第十批国采开标，各省及联盟集采也有新进展。 01 163个产品、109家企业拟中选 12月10日，河北牵头的京津冀化学药品集中带量采购拟中选结果公示，集采目录中碘美普尔、复方氢溴酸右美沙芬、尿素等品种未出现在名单中，最终共163个产品拟中选（名单及价格见文末附1）。 据赛柏蓝梳理，此次拟中选的163个产品有90个已过评，1个产品为原研药品，阿斯利康、齐鲁、人福等109家企业拟中选（按申报企业计），涉及注射用苯唑西林钠、他克莫司软膏、盐酸纳布啡注射液等95个品种（含不同剂型）。 本月初，江西宣布参与此次联盟采购，其药品约定量以上一年度实际采购量的80%计算。 在12月14日申(投)诉受理期结束前，如有企业被举报资质造假或虚报价格，经核实后将被取消对应拟中选资格；公示无异议的药品将作为此次集采中选药品。 02 760个产品通过形式审查 12月9日，甘肃省公共资源交易中心对其第六批药品集中带量采购（带量联动专项）形式审核结果展开公示，公示期至12月12日。 本次带量采购纳入了利巴韦林、氨咖黄敏、阿奇霉素等79个其它省份已集采且过评企业（含原研和参比制剂）数4家及以下的中成药和化学药品种，共申报815个产品（名单及报价见文末附2）。 经形式审核，760个产品符合申报要求，55个产品不符合申报要求，复核未通过的原因主要包括不同包材价格高、不同包装不符合差比、未按要求申报等。 原中选企业需填报最小包装中选价，非中选企业填报最小意向包装价。按照要求，最小意向包装价不得高于全国最低价（含集采中选价），本轮的意向价将作为医疗机构上报需求量的参考价，下一轮最终报价不得高于本轮申报意向价。 03 48个品种，十三省带量采购 12月7日，广州公共资源交易中心发布关于发布《广东联盟阿哌沙班片等药品集中带量采购文件》的通知，广东、安徽、福建、江西、湖北、湖南、重庆、四川、云南、西藏、陕西、甘肃、新疆等13省（区、市）组成省级联盟，开展第三、四、五批国采期满品种接续工作，共纳入阿哌沙班、恩格列净、紫杉醇等48个品种（含不同剂型，详见文末附3）。 在拟中选/中选限量产品确定上，企业报价P≤最高有效申报价格和申报品规最低价格两者低值的，获得拟中选限量资格，最低可获得医疗机构报量的70%。 同品种同组获得拟中选限量企业的报价P同时满足以下条件之一的获得拟中选资格，获得100%的医疗机构报量：（1）按P“单位可比价”由低到高，排名在数量要求之内的企业；（2）P的“单位可比价”≤0.1000元。 04 50个化药、28个中成药拟中选 日前，浙江省公立医疗机构第五批药品集中带量采购拟中选结果出炉，正式中选结果预计将在下周（12月16日后）发布。 拟中选名单包含78个产品（详见文末附4），其中化药50个、中成药28个，浙江此次集采对化药、中成药分别展开综合评审，技术评分明细表也随拟中选结果一并进行了公示。 中选企业将根据2023年全省所有公立医疗机构采购份额确定约定采购量。如A、B两组中任意一组无中选药品，则该组约定采购量基数的50%归并至另一组，剩余50%作为约定采购量以外的剩余用量。 有2个分组的品种，若其中一组产品无约定采购量基数或约定采购量基数低于同品种总量的10%的，约定采购量按以下方式确定： 05 41个中成药大品种，启动报量 近日，多地陆续下发通知展开广东联盟金莲花胶囊等中成药集中带量采购需求量填报工作。 该联盟采购文件于11月中旬发布征求意见稿，由广东牵头辽宁、吉林、黑龙江、江西、湖南、广西、海南、重庆、云南、陕西、青海、宁夏、新疆、新疆生产建设兵团等15个省市区展开。 以此前广东联盟组织的清开灵等中成药品种进行采购，其中全国中成药联盟集中带量采购第三批和首批扩围接续采购品种范围重叠的药品剂型不列入集采范围，涉及金莲花、复方血栓通、复方丹参等41个品种（详见文末附5）。 本月初起，联盟地区各地接连下发通知展开报量，目前各地跟进参与的品种数量不一。 例如，陕西商洛近日对金莲花片（胶囊、颗粒、口服液、软胶囊）、抗病毒胶囊（颗粒、口服液）等17个大品种展开数据填报，12月19日前完成；江西参与其中20个品种，12月19日前完成填报；新疆对所有品种进行了跟进，要求医疗机构在12月17日前完成填报。 按照此前文件，后续拟中选企业的确定可分为五类情况—— 综合来看，上一轮集采中选结果将成为企业此次能否中选的重要参考。 附1：京津冀赣化学药品集中带量采购拟中选结果 滑动查看更多 附2：甘肃第六批药品集中带量采购（带量联动专项）形式审核结果 滑动查看更多 附3：广东联盟阿哌沙班片等药品集中带量采购清单 附4：浙江省公立医疗机构第五批药品集中带量采购拟中选结果 附5：广东联盟金莲花胶囊等中成药集中带量采购范围 END 内容沟通：郑瑶（13810174402） 左下角「关注账号」，右下角「在看」，防止失联

Independent Data Monitoring Statistician reaffirmed current sample size to remain at N=160 The trial has reached 75% of the targeted enrollment, and topline results continue to be expected in the first half of 2025 NEW HAVEN, Conn., Dec. 12, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced the positive outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in IPF patients with chronic cough, which requires no change to the current sample size for the trial (N=160). The trial has reached 75% of the targeted enrollment, and topline results from the full trial continue to be expected in the first half of 2025. The SSRE analysis was conducted on the highest dose (108mg twice daily) in the trial after 50% of the initial targeted trial enrollment, or 80 patients, completed the six weeks of treatment. Based on the SSRE analysis, it was recommended that the CORAL trial should continue as planned to maintain the pre-specified conditional power of 80% or greater. The other two potential pre-specified outcomes of the SSRE analysis were an increase in the sample size or futility. "We are pleased that the SSRE outcome supports the continued execution of the CORAL trial with the total number of patients as originally planned," said Jennifer Good, President and CEO of Trevi Therapeutics. "This positive SSRE outcome is reassuring and confirms the key powering assumptions of the trial design. We believe this is additional confirmation of the strong efficacy observed in the Phase 2a CANAL trial in IPF cough and is an important milestone reaffirming our belief in Haduvio's best-in-class and first-in-class potential for patients with IPF chronic cough where there are no approved therapies." Phase 2b IPF Chronic Cough Trial Design (CORAL): The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) compared to placebo in IPF patients with chronic cough. Approximately 160 IPF patients with chronic cough will be randomized 1:1:1:1 to one of three Haduvio doses or placebo for a period of 6 weeks. This includes an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at the end of Week 6 versus baseline for Haduvio compared to placebo, as measured with an objective cough monitor (VitaloJAK®). The trial will also explore secondary endpoints, including patient reported outcome measures for cough. About Trevi Therapeutics, Inc. Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency. Chronic cough is a highly prevalent disease in IPF patients, impacting up to 85% of the IPF population. There are ~140,000 U.S. IPF patients and the impact of chronic cough is significant with patients coughing up to 1,500 times per day. This consistent cough and associated damage may lead to worsening disease, a higher risk of progression, death, or need for lung transplant. Chronic cough also often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in IPF and current off-label treatment options provide minimal benefit to patients. Refractory chronic cough affects approximately 2-3 million adults in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is highly disruptive and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them. Haduvio is being developed for the treatment of moderate to severe RCC. There are also no approved therapies for RCC in the U.S. Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. For more information, visit and follow Trevi on X (formerly Twitter) and LinkedIn. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing clinical trials; the risk that positive data from a clinical trial, or from the sample size re-estimation analysis announced in this press release, may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries, as well as other risks and uncertainties set forth in Trevi's quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investor Contact Katie Barrett Trevi Therapeutics, Inc. 203-304-2499 [email protected] Media Contact Rosalia Scampoli 914-815-1465 [email protected] SOURCE Trevi Therapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED