Oxycodone

点击上方蓝字 关注我们2025年5月11日，由新乡医学院第一附属医院路平教授牵头开展的“氢吗啡酮PCA泵简易模式在重度或癌痛危象患者居家管理应用的全国多中心临床研究”（简称“Chase 008研究”）启动会在湖北宜昌成功召开。此次会议采取线上线下相结合的形式召开，来自全国各地的多家单位参加了此次全国多中心临床研究启动会，包括河南省周口市中心医院、河南省安阳市人民医院、河南省鹤壁市人民医院、河南省新野县人民医院、陕西省西安市中心医院、陕西省西安市第九医院、安徽省太和县人民医院、湖北省保康县人民医院、海南省琼海市人民医院、江西省丰城市人民医院、山西省汾阳医院等。新乡医学院第一附属医院路平教授和宜昌人福药业有限责任公司党委书记、董事长李杰先生出席会议并致辞。周口市中心医院肿瘤科徐克友教授担任会议主持，新乡医学院第一附属医院赵可雷教授和张敏教授分别分享了“氢吗啡酮PCA泵简易模式在重度或癌痛危象患者中应用管理单臂多中心临床研究”（简称“Chase 002研究”）成果和“Chase 008研究”方案，以新乡医学院公共卫生学院的王永斌教授为代表的全体专家参与讨论并对下一步研究计划提出了切实的建议。主席致辞路平 教授新乡医学院第一附属医院李杰 先生宜昌人福药业有限责任公司研究分享赵可雷 教授新乡医学院第一附属医院张敏 教授新乡医学院第一附属医院专家讨论张永喜 教授新乡医学院第三附属医院乔盼盼 教授灵宝市第一人民医院王林俭 教授新野县人民医院韩瑜 教授济源市人民医院崔月龙 教授安阳地区医院王永亮 教授安阳市人民医院刘京 教授鹤壁市人民医院代翠莲 教授兰考县中心医院智建潮 教授虞城县人民医院赵勇 教授浚县人民医院向右滑动查看更多→聚焦前沿，氢吗啡酮PCA简易模式提供科研新方向会议伊始，新乡医学院第一附属医院路平教授强调“Chase 008研究”项目的重大意义：“癌痛治疗是当前全球公共卫生领域的重大挑战，此次研究以氢吗啡酮PCA简易模式居家镇痛为核心，旨在为癌痛患者提供更安全、有效的解决方案，同时推动县域医疗机构在该领域的科研突破。”全国人大代表，宜昌人福药业有限责任公司党委书记、董事长李杰先生从企业社会责任、产品研发方向、行业痛点以及社会认知等多个角度谈到对癌痛全程管理的看法，希望通过“Chase 008研究”建立“居家疼痛管理中国标准”，为全球重度或癌痛危象管理贡献东方智慧，通过产学研深度融合，打造“以患者为中心”的全程管理模式，让镇痛治疗从医院延伸到家庭，惠及广大癌痛患者。技术创新，氢吗啡酮注射液PCA+氢吗啡酮缓释片口服为癌痛全程管理提供新思路启动会上，新乡医学院第一附属医院赵可雷教授和张敏教授从研究背景、设计思路、实施方案、预期成果等方面分别对“Chase 002研究”成果和“Chase 008研究”方案进行了全面汇报。“Chase002研究”主要探索了氢吗啡酮PCA泵简易模式在重度或癌痛危象患者中应用的有效性和安全性。13家研究单位在一年的时间内完成了100例受试者入组。结果显示：①前期未使用阿片药物治疗患者，氢吗啡酮起始2mg维持24h滴定方式安全可靠；②氢吗啡酮皮下持续给药模式相对于口服/贴剂吸收效率高、稳定；③对于阿片未耐受/未进行阿片治疗患者，疼痛滴定可能进一步简化；④重度疼痛患者，即便滴定成功，仍需要3-4天剂量上调整才能达到稳定状态；⑤10天PCA便捷模式便于调整背景剂量，能快速达到需求剂量；⑥D1-10止痛效果未见明显衰减，稳定持续给药，持续时间越长，PCA次数越少（持续稳定镇痛过后会进入平台期)。“Chase008研究”作为一项多中心、对照、开放标签试验，是“Chase002研究”项目的延伸。该研究计划在全国50家县域医疗机构同步开展，覆盖367例患者。为进一步验证“简易模式”对癌症患者合并重度癌痛、癌痛危象、或难治性癌痛患者的疼痛居家治疗的有效性、安全性及生活质量的改善作用，为“氢吗啡酮PCA泵简易模式”在重度癌痛治疗的应用提供临床依据，同时也为重度癌痛患者的居家止痛方式提供更优选择。该研究将严格遵循国际GCP标准及伦理规范，确保研究数据的科学性与可靠性。阿片类药物作为癌痛全程管理的基础用药，近年来国内上市的新剂型及新品种较少，传统的治疗药物以吗啡、羟考酮口服制剂以及芬太尼透皮贴为主，氢吗啡酮是一种半合成的阿片类镇痛药，主要作用于μ阿片受体，其口服效力约为吗啡的5倍，胃肠外途径给药时其镇痛药效约是吗啡的8-10倍，主要代谢产物无活性，不良反应少于吗啡，是指南共识推荐中重度癌痛治疗的一线用药。目前，该活性成分在国内有注射液、缓释片两种制剂获批上市。氢吗啡酮的上市填补了国内空白，为临床使用带来更多便利性，为癌痛患者带来曙光！盐酸氢吗啡酮缓释片是国内首个24小时口服一次的长效阿片类缓释制剂，相较于临床常用的吗啡和羟考酮的口服缓释制剂更加贴合NCCN指南癌痛治疗的5A目标。它采用独特的口服渗透泵缓释技术（Osmotic Release Oral System，OROS），24小时持久镇痛，一天仅需口服一次，患者依从性更高，且释药呈零级动力学，不受介质环境影响，患者血药浓度更加平稳，因为释药口细小和悬液的黏度高，很难用针头或口吸的方法达到滥用的目的，具有防滥用的特性，适用于临床中重度癌痛的维持治疗和轮替用药。群策群力，为癌痛规范化诊疗提供中国方案在专家研讨环节，来自全国多个县域地区的专家就研究方案优化、患者招募策略、数据管理技术等议题展开深度交流。现场讨论热烈，专家一致认为，该项目填补了居家镇痛多中心临床研究的空白，具有显著的临床价值，并针对癌痛治疗药物等创新方向提出了宝贵建议。此次启动会的顺利召开标志着氢吗啡酮PCA泵简易模式在重度或癌痛危象患者居家管理应用的全国多中心临床研究正式启动，将为癌痛患者居家镇痛管理提供了更多解决方案，为癌痛患者带来更多希望！（来源：《肿瘤瞭望》编辑部）声 明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

Receives U.S. Patent for Groundbreaking Treatment for Opioid Use Disorder Clinical Trial on Novel Analgesic, PF614-MPAR, Demonstrates Overdose Protection SAN DIEGO, CA / ACCESS Newswire / May 13, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today reported financial and operational results for the first quarter ended March 31, 2025. Dr Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "We are pleased with the meaningful strides the Company has continued to make in the first quarter to deliver what we believe are the ‘Next Generation' opioid analgesics with both abuse and overdose protection. Included in our recent accomplishments was the receipt of a Notice of Allowance from the U.S. Patent and Trademark Office for our lead opioid use disorder (OUD) drug candidate, PF9001. This patent adds to our portfolio of over 100 patents that span 25 countries around the world for our TAAP and MPAR® technologies in the pain and attention deficit disorder space. PF9001 is designed to have several advantages over current methadone therapy including overdose protection from our MPAR technology and reduced cardiotoxicity, which is a serious side effect seen with medications used today. We believe our approach to OUD therapy utilizing our novel TAAP and MPAR technologies will improve outcomes for patients through an increase in treatment adherence as well as provide much easier access to these critical therapies for those who struggle with this disorder." Dr. Kirkpatrick continued, "Additionally in April, we were pleased to announce completion of another critical milestone in the development of our opioid overdose protection. Part 1 of our PF614-MPAR-102 clinical study finished enrollment and confirmed protection from the risk of overdose when PF614-MPAR at any dose level is consumed accidentally or deliberately. We look forward to enrolling Parts 2 and 3 of the study which will continue to examine other properties of PF614-MPAR to support its use to treat severe pain when other analgesics are ineffective." "We believe Ensysce is set to disrupt the analgesic opioid market with our lead products PF614 and PF614-MPAR. Our mission has been to use "clever chemistry" to deliver a novel opioid analgesic featuring both abuse and overdose protection while retaining opioid-grade efficacy. As we approach the second half of the year, we have set in place plans for clinical and regulatory progress and look forward to continuing to provide updates on our TAAP, MPAR and OUD programs. The opioid crisis continues to claim close to 100,000 lives annually in the U.S. alone. Ensysce aims to not only save lives, but to reshape the way society approaches pain and addiction." TAAP TM (Opioid Abuse Deterrent Program) Update The Company's lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAP TM ) extended-release oxycodone and a potential "next generation" analgesic to treat severe pain. PF614's TAAP TM chemical modification of oxycodone makes it inactive until it is swallowed and exposed to the body's own trypsin in the small intestine to activate or "switch on" to release oxycodone. The TAAP TM technology is designed to control release when administered orally, be highly resistant to tampering, and reduce abuse, with a goal of providing what the Company believes is a safer opioid product for those suffering with severe pain who require opioid-strength analgesia. Having received FDA feedback on the Phase 3 design for the PF614-301 clinical study, entitled "A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty", in December 2024, the Company has continued to perfect its study plans, working towards initiating the trial in mid-year 2025, and will continue to provide updates as the program develops. MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update PF614-MPAR is a combination product of the TAAP TM and MPAR® (Multi-Pill Abuse Resistance) technology to treat severe pain with the added benefit of oral overdose protection. PF614-MPAR combines prodrug PF614 with a trypsin inhibitor to reduce or "switch off" the release of the opioid in an overdose situation. Data from the initial clinical trial PF614-MPAR-101, demonstrating that the MPAR® technology worked as designed to provide the desired overdose protection to PF614-MPAR at a 25 mg dose, led to the FDA's Breakthrough Therapy designation in January 2024. During the second quarter of 2025, the Company announced the completion of Part 1 of its second clinical trial, PF614-MPAR-102, that evaluated higher doses of PF614-MPAR for overdose protection. This Part of the study confirmed the earlier data from PF614-MPAR-101, showing that MPAR® technology can reduce risk from excessive doses when consumed accidentally or deliberately. The Company has now progressed to Part 2 of the three-part study and will examine whether there are any food effects on this MPAR® technology. The aggregate data will allow the Company to focus on perfecting a final drug product to move into commercialization and will be discussed with the FDA in an upcoming regulatory meeting. Opioid Use Disorder (OUD) Program Update In addition to pain management, Ensysce is advancing treatments for opioid use disorder, including innovative compounds that we believe will reduce cravings and block relapse without impairing quality of life. The Company has used its TAAP and MPAR® technology to provide what could be a safer methadone analogue to treat OUD. In 2024, a lead OUD drug candidate PF9001 was selected and has been evaluated for oral delivery, the potential for reduced cardiovascular side effects and overdose protection. The intent of the program is to provide a safer product to treat OUD, and to make OUD treatment more accessible to those who need it. The program, supported by a multi-year Helping to End Addiction Long-Term (HEAL) award, is planned to continue to non-clinical studies to support submission of an Investigational New Drug application in the future. In another milestone for this program, the Company announced in April it had secured patent protection for the OUD platform. A Notice of Allowance from the U.S. Patent and Trademark Office was issued for a patent entitled: Enzyme-Cleavable Methadone Prodrugs and Methods of Use Thereof¹ which includes both composition of matter and method of use claims for PF9001. Q1 2025 Financial Results Cash - Cash and cash equivalents were $3.1 million as of March 31, 2025, compared to $3.5 million as of December 31, 2024. Subsequent to the end of the quarter, the Company received gross proceeds of $2.2 million, prior to deducting placement agent fees and offering expenses, from the exercise of warrants originally issued in March 2025. Federal Grants - Funding under federal grants totaled $1.3 million for the first quarter of 2025 compared to $0.3 million in the comparable year ago quarter. The $1.0 million difference is due to the timing of research activities eligible for funding, with increased activities under the MPAR grant which began in September 2024. Research & Development Expenses - R&D expenses were $1.9 million for the first quarter of 2025 compared to $0.8 million for the same period in 2024. The increase was primarily the result of external research and development costs related to PF614-MPAR, with increased pre-clinical activity in the 2025 period. General & Administrative Expenses - G&A expenses were consistent at $1.4 million in the first quarter of both 2025 and 2024. Other Income (Expense) - Total other income (expense) was income of $21,939 for the first quarter of 2025 compared to expense of $1.3 million in the same period of 2024. Other expense for the 2024 period consisted primarily of interest expense associated with the amortization of the original issue discount and debt issuance costs for convertible notes issued in 2023. Net Income (Loss) - Net loss attributable to common stockholders for the first quarter of 2025 was $1.9 million compared to a net loss of $3.1 million for the first quarter of 2024. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future. ¹The research covered by this patent was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number UG3DA050271. About Ensysce Biosciences Ensysce Biosciences is a clinical-stage company with a goal of disrupting the analgesic landscape by introducing a new class of highly novel opioids for the treatment of severe pain. Leveraging its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose. Ensysce's products are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuse. For more information, please visit www.ensysce.com. Definitions TAAP™: trypsin activated abuse protection - designed to protect against prescription drug abuse. MPAR®: multi-pill abuse resistance - designed to protect against abuse and accidental overdose. Forward-Looking Statements Statements contained in this press release that are not purely historical may be deemed to be forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Without limiting the foregoing, the use of words such as "may," "intends," "can," "might," "will," "expect," "plan," "possible," "believe" and other similar expressions are intended to identify forward-looking statements. The product candidates discussed are in clinic and not approved and there can be no assurance that the clinical programs will be successful in demonstrating safety and/or efficacy, that Ensysce will not encounter problems or delays in clinical development, or that any product candidate will ever receive regulatory approval or be successfully commercialized. All forward-looking statements are based on estimates and assumptions by Ensysce's management that, although Ensysce believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Ensysce expected. In addition, Ensysce's business is subject to additional risks and uncertainties, including among others, possible NASDAQ delisting, the initiation and conduct of preclinical studies and clinical trials; the timing and availability of data from preclinical studies and clinical trials; expectations for regulatory submissions and approvals; potential safety concerns related to, or efficacy of, Ensysce's product candidates; the availability or commercial potential of product candidates; the ability of Ensysce to fund its continued operations, including its planned clinical trials; the dilutive effect of stock issuances from our fundraising; and Ensysce's and its partners' ability to perform under their license, collaboration and manufacturing arrangements. These statements are also subject to a number of material risks and uncertainties that are described in Ensysce's most recent annual report on Form 10-K and current reports on Form 8-K, which are available, free of charge, at the SEC's website at www.sec.gov. Any forward-looking statement speaks only as of the date on which it was made. Ensysce undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Ensysce Biosciences Company Contact:Lynn Kirkpatrick, Ph.D.Chief Executive Officer(858) 263-4196 Ensysce Biosciences Investor Relations Contact:Shannon DevineMZ North AmericaMain: 203-741-8811ENSC@mzgroup.us Ensysce Biosciences, Inc.Condensed Consolidated Statements of Operations(Unaudited) Three Months Ended March 31, 2025 2024 $ 1,319,772 $ 305,722 1,885,528 778,904 1,401,756 1,369,782 3,287,284 2,148,686 (1,967,512 ) (1,842,964 ) Total other income (expense), net 21,939 (1,273,599 ) $ (1,945,573 ) $ (3,116,563 ) - (216 ) $ (1,945,573 ) $ (3,116,779 ) $ (1.39 ) $ (8.21 ) Ensysce Biosciences, Inc.Condensed Consolidated Statements of Cash Flows(Unaudited) Three Months Ended March 31, 2025 2024 $ (1,707,412 ) $ (3,408,403 ) 1,257,826 5,689,148 (449,586 ) 2,280,745 3,502,077 1,123,604 $ 3,052,491 $ 3,404,349 Ensysce Biosciences, Inc.Condensed Consolidated Balance Sheets(Unaudited) March 31, December 31, 2025 2024 $ 3,052,491 $ 3,502,077 1,348,500 1,842,605 4,400,991 5,344,682 210,883 252,550 $ 4,611,874 $ 5,597,232 $ 615,295 $ 1,357,079 888,498 548,458 257,383 301,660 1,761,176 2,207,197 130,180 10,096 1,891,356 2,217,293 2,720,518 3,379,939 $ 4,611,874 $ 5,597,232 SOURCE: Ensysce Biosciences Released May 13, 2025