Oxycodone Hydrochloride

2024年11月15日—17日，2024中国整合肿瘤学大会（CCHIO）癌症康复与姑息治疗分会以及癌痛整合治疗分会分别在西安国际会展中心、西安国际会议中心成功召开。中国抗癌协会癌症康复与姑息治疗专业委员会（CRPC）主任委员罗素霞教授、前任主任委员张力教授、副主任委员王杰军教授以及中国抗癌协会癌痛整合治疗专业委员会主任委员谢广伦教授分别担任两个分会的大会主席，天津医科大学肿瘤医院王昆教授、浙江大学医学院附属邵逸夫医院潘宏铭教授、河北医科大学第四医院宛春甫教授、郑州大学第二附属医院张君教授、湖南省肿瘤医院周志国教授、中国科学院合肥肿瘤医院邓国魁教授分别担任大会主持。会议内容吸引了大批有志于癌痛治疗的专家和医生参会，同时邀请多位肿瘤、疼痛等领域知名专家带来阿片类药物研究新进展、鞘内镇痛、癌症相关病理性疼痛、PCA癌痛治疗应用、阿片类药物相关不良反应防治、癌痛系列临床研究等癌痛全程管理相关最前沿研究报告，多位学术大咖共聚一堂各抒己见，内容丰富，精彩纷呈。 主席致辞 罗素霞 教授 河南省肿瘤医院 张力 教授 中山大学肿瘤防治中心 王杰军 教授 海军军医大学附属长征医院 谢广伦 教授 河南省肿瘤医院 会议现场 癌症康复与姑息治疗分会场 癌痛整合治疗分会场 专家授课  《阿片类药物研究进展》 罗素霞 教授 河南省肿瘤医院 癌痛药物治疗缺乏有效手段，氢吗啡酮填补临床空白 罗素霞教授作了《阿片类药物研究进展》的专题学术报告，就当前癌痛治疗领域中涌现出的新药品如盐酸氢吗啡酮缓释片（商品名：锐宁®）、他喷他多片、芬太尼口腔贴片等从临床研究和药物未来前景等方面做了细致阐述。 阿片类药物为癌痛全程管理的基础用药，传统的治疗药物以吗啡、羟考酮口服即释、缓释制剂以及芬太尼透皮贴为主，近年来国内涌现新剂型及新品种较少，氢吗啡酮为其中突出代表。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，起效快，主要代谢产物无活性，不良反应少，是众多指南共识推荐的中重度癌痛治疗一线用药。目前，该活性成分国内有注射液、缓释片两种制剂获批上市，氢吗啡酮的上市正在填补国内空白，为临床使用带来更多便利性，为癌痛患者带来新曙光！ 盐酸氢吗啡酮缓释片作为宜昌人福药业独家上市的药品，是国内首个24小时长效口服阿片类缓释制剂，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），可提供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。 《重度癌痛快速滴定及维持治疗的临床实践》 黄诚 教授 福建省肿瘤医院 《癌痛系列临床研究》 林榕波 教授 福建省肿瘤医院 癌痛三阶梯治疗理念不断发展，癌痛治疗新技术取得成功 黄诚教授和林榕波教授分别以《重度癌痛快速滴定及维持治疗的临床实践》、《癌痛系列临床研究》为主题作专题学术报告，主要对盐酸氢吗啡酮注射液用于快速滴定的临床研究作了细致的阐述。 由福建省肿瘤医院黄诚教授和林榕波教授团队发起的一项“常规口服吗啡对比氢吗啡酮IPCA（静脉患者自控镇痛）持续输注加补救剂量(CIRD)或仅HM推注(BO)治疗重度癌痛：一项随机III期研究”获得了2024年ESMO年会的LBA形式口头报告（Proffered Paper）资格并入选了大会高光研究！据了解，这是中国癌痛治疗领域在世界最高肿瘤盛会上拿到的最高级别发言。这一荣誉不仅是对福建省肿瘤医院科研力量的高度认可，更是对中国在癌痛领域的认可。 此研究是一项前瞻性、多中心、随机对照Ⅲ期临床研究，主要研究目的为在重度癌痛患者[11点数字评定量表（NRS）静息时评分≥7分]中，使用氢吗啡酮（HM）持续输注+补救剂量（CIRD）或仅氢吗啡酮推注（HM BO）的静脉（IV）患者自控镇痛（IPCA）对比全天候（ATC）口服缓释（ER）吗啡+速释（IR）吗啡的疗效与安全性。研究共纳入重度（NRS≥7分）癌痛患者1349例，随机分为三组，其中A1组（IPCA HM，BO按需PRN）542例，A2组（IPCA HM，CIRD）540例，B组（口服ER吗啡+IR吗啡）267例。研究的主要疗效指标为1-3天的平均NRS评分（3DNRS，第1-3天24小时平均NRS之和除以3）变化。研究结果显示，A1组的3DNRS均值显著低于B组[2.36（SD 0.89），P<0.001]。第3天和第6天的NRS评分和受试者满意度在A1组和A2组之间无显著差异，但优于B组。B组的每日等效吗啡消耗量最高，其次是A2组，A1组最低。与A1组和A2组相比，B组中阿片类药物相关不良事件的发生率显著更高。 此前，福建省肿瘤医院黄诚、林榕波教授团队发起的 “氢吗啡酮PCA（患者自控镇痛技术）对比非PCA静脉滴定治疗重度癌痛多中心、随机对照III期研究”和“重度癌痛患者滴定成功后氢吗啡酮静脉PCA对比吗啡口服维持治疗的多中心、Ⅱ期随机对照临床研究”都已在NCCN（美国国家综合癌症网络）官方杂志《JNCCN》（Journal of the National Comprehensive Cancer Network, IF:12.69）进行发表。同时，两项研究已相继在2019年、2020年美国临床肿瘤学会（ASCO）年会，2020-2023年 ESMO Asia年会和ESMO年会期间进行壁报展示交流和Mini oral。但是对于重度癌痛患者滴定成功之后的最佳后续治疗仍需要探索。此研究就是扩大样本后氢吗啡酮PCA对比吗啡口服维持治疗的问题探究。结果显示对于重度癌痛的管理，与传统口服吗啡相比，有或没有持续输注的IPCA HM提供了更优的疼痛控制。此外，采用BO的IPCA HM非劣效于采用CIRD的IPCA HM，表明IPCA的PRN方法是管理重度癌痛的有效选择。 本次大会为临床医生带来了癌痛领域最前沿的学术资讯，同时也为癌痛管理提供了更多专业、规范的治疗建议，其宗旨是促进国内与国际间癌痛领域的学术交流和技术进步，提升我国癌痛管理水平，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。

Awarded $14 Million Multi-Year NIH Grant and Initiated Second Clinical Trial for Breakthrough Therapy PF614-MPAR Submitted Pivotal PF614 Phase 3 Protocol to the FDA for Review SAN DIEGO, CA / ACCESSWIRE / November 12, 2024 / 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 third quarter ended September 30, 2024. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our team has made significant progress in the third quarter, and we have line of sight to meaningful clinical initiatives to close out the year. The highlight of the third quarter was NIH's recognition of the potential value provided by our overdose protection technology MPAR®, by awarding Ensysce with a $14 million multi-year grant to further the clinical development of PF614-MPAR. The support from the NIH allows the completion of a second Phase 1b trial, PF614-MPAR-102. We believe the data from this study will cement PF614-MPAR as the first opioid with oral overdose protection, a game-changer for those suffering with severe pain while mitigating potential abuse and overdose." Dr. Kirkpatrick continued, "We also built on FDA feedback from our End of Phase 2 meeting in February to complete our Phase 3 protocol and have submitted it to the FDA. We expect FDA feedback by the end of November to allow us to complete plans to execute the study over the coming year. Our August financing transaction that raised $5 million in gross proceeds allows us to advance to clinical site selection for our pivotal Phase 3 trial for PF614, and the $14 million MPAR® grant has allowed us to rapidly initiate our second trial for PF614-MPAR. We anticipate the results from these clinical studies will continue to build on our prior positive safety data to bring our innovative and premium pain products to market. Lastly, we are applying our TAAP and MPAR technology to our opioid use disorder program and look forward to moving the lead agent into clinical development in the coming years." TAAPTM (Opioid Abuse Deterrent Program) Update Our lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone and a potential "next generation" analgesic for severe pain. The Company's TAAPTM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification. PF614's TAAPTM modification 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. During the third quarter, the Company submitted to the FDA for regulatory review the protocol and statistical analysis plan for its anticipated final Phase 3 study, PF614-301. The study is 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". MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update PF614-MPAR, designed to treat severe pain with added oral overdose protection, is a combination product of the TAAPTM prodrug PF614 with a trypsin inhibitor. MPAR® (Multi-Pill Abuse Resistance) reduces or "switches off" the release of the opioid only in an overdose situation, providing an additional layer of protection to Ensysce's TAAP™ medications. The clinical data from the first clinical trial, PF614-101, demonstrated that the MPAR® technology reduces release and absorption of oxycodone from PF614 when consumed in more than a prescribed dose, leading to the FDA's Breakthrough Therapy designation in January of this year. During the third quarter, the Company received approval from the Investigational Review Board ("IRB") of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' The Site Initiation Visit has been undertaken and the study is on track to initiate subject dosing this quarter. To execute this study, Ensysce has continued its collaboration with Quotient Sciences to use their Translational Pharmaceutics® platform to perfect the drug product. As reported in August, the Company received a $14 million multi-year grant from the NIH, National Institute of Drug Abuse (NIDA) to fund this clinical study as well as the necessary non-clinical studies to support an NDA (New Drug Application) for PF614-MPAR. Opioid Use Disorder (OUD) Program Update The Company recently announced the selection of its lead OUD drug candidate PF9001 that has been designed using Ensysce's TAAPTM platform. The intent of the program is to reduce both the abuse profile and the cardiovascular side effects associated with traditional methadone OUD treatments. The program is finalizing required studies supported by a multi-year Helping to End Addiction Long-Term (HEAL) award of up to $15 million granted by the NIH and NIDA and anticipates advancing to Investigational New Drug (IND) enabling studies in the coming year. Q3 2024 Financial Results Cash - Cash and cash equivalents were $4.2 million as of September 30, 2024, compared to $1.1 million as of December 31, 2023. A key driver for the increase in cash was cumulative net proceeds of $8.5 million from equity financings in February and August 2024. Stockholders' Equity - Stockholders' equity was $6.6 million as of September 30, 2024, a level compliant with the $2.5 million stockholders' equity requirement set forth in Nasdaq Listing Rule 5550(b)(1). Federal Grants - Funding under federal grants totaled $3.4 million for the third quarter of 2024 compared to $0.4 million in the comparable year ago quarter. The increase is due to the timing of research activities eligible for funding, with increased activities under the OUD grant following the selection of a lead drug candidate in June. Funding under the current phase of the OUD grant was completed in August 2024. Also contributing to the increase is the recently awarded MPAR grant, with payments for clinical activities for PF614-MPAR initiated during the quarter. With the completion of the OUD grant, funding under federal grants is expected to decline in coming quarters from the level of the third quarter of 2024. Research & Development Expenses - R&D expenses were $1.7 million for the third quarter of 2024 compared to $1.9 million for the same period in 2023. The decrease of $0.2 million was primarily the result of reduced external research and development costs related to clinical and pre-clinical programs for PF614 in the 2024 period. Increased activities on the OUD and MPAR programs are expected to result in higher research and development expenses in coming quarters. General & Administrative Expenses - G&A expenses were $1.1 million in the third quarter of 2024, compared to $1.2 million for the third quarter of 2023, a slight decrease of $0.1 million. G&A expenses are expected to approximate current levels in the coming quarters. Other Income (Expense) - Total other income (expense), net, was consistent with income of $17,023 for the third quarter of 2024 compared to income of $16,508 for the same period of 2023. Net Income (Loss) - Net income attributable to common stockholders for the third quarter of 2024 was $0.7 million compared to a net loss of $2.7 million for the third quarter of 2023. The Company recorded net income in the third quarter due to the timing of federal grant funding received, with the completion of funding under the OUD grant and the start of funding under the MPAR grant both occurring during the quarter. With only the MPAR grant moving forward, net income for the third quarter is expected to be a one-time event and we do not anticipate net income in coming quarters. 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. About Ensysce Biosciences Ensysce Biosciences is a clinical-stage company using its proprietary technology platforms to develop safer prescription drugs. 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. The platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions. 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 quarterly report on Form 10-Q 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) 2024 2023 2024 2023 $ 3,418,853 $ 435,380 $ 3,906,372 $ 1,715,488 1,690,674 1,914,970 3,416,807 5,354,713 1,083,433 1,227,724 3,643,223 3,923,277 2,774,107 3,142,694 7,060,030 9,277,990 644,746 (2,707,314 ) (3,153,658 ) (7,562,502 ) 17,023 16,508 (1,268,929 ) 440,588 $ 661,769 $ (2,690,806 ) $ (4,422,587 ) $ (7,121,914 ) - 1,235 (216 ) 198 $ 661,769 $ (2,689,571 ) $ (4,422,803 ) $ (7,121,716 ) $ 0.07 $ (0.87 ) $ (0.57 ) $ (3.32 ) Ensysce Biosciences, Inc.Condensed Consolidated Statements of Cash Flows(Unaudited) Nine Months Ended September 30, 2024 2023 $ (6,738,610 ) $ (8,978,107 ) 9,768,598 7,294,786 3,029,988 (1,683,321 ) 1,123,604 3,147,702 $ 4,153,592 $ 1,464,381 Ensysce Biosciences, Inc.Condensed Consolidated Balance Sheets(Unaudited) September 30, December 31, 2024 2023 $ 4,153,592 $ 1,123,604 4,936,915 1,165,264 9,090,507 2,288,868 294,217 419,217 $ 9,384,724 $ 2,708,085 $ 1,967,573 $ 1,936,007 447,035 542,260 387,176 854,697 2,801,784 3,332,964 3,213 26,388 2,804,997 3,359,352 6,579,727 (651,267 ) $ 9,384,724 $ 2,708,085 SOURCE: Ensysce Biosciences, Inc. Released November 12, 2024