Sleep Apnea Syndromes

Evidence demonstrates that SUBLOCADE supports long-term recovery from opioid use disorder (OUD) and is effective and safe. Publications highlight the importance of overcoming access barriers to long-acting injectable treatments for OUD RICHMOND, Va., Oct. 30, 2024 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV), in recognizing Substance Abuse Prevention Month, provides an update on key findings from the last year that demonstrate the importance of access to medications for the treatment of opioid use disorder (MOUD) and the effectiveness and safety of SUBLOCADE® in the treatment of OUD. These data add to the growing body of evidence that SUBLOCADE can improve outcomes, such as abstinence, retention, and recovery in persons with OUD. Publications In a post hoc analysis of the SUBLOCADE randomized, double-blind, placebo-controlled phase 3 clinical trial, published in Harm Reduction Journal, SUBLOCADE 300 mg maintenance dose resulted in a statistically significant increase in abstinence from opioids among study participants with OUD who injected opioids compared to 100 mg maintenance dose. However, both were equally effective in non-injecting participants. Results from the Community Long-Acting Buprenorphine (CoLAB) Study, a prospective single-arm, multicenter, open label trial in Australia, were published in the International Journal of Drug Policy, and demonstrated that participants could be maintained on SUBLOCADE treatment for 96 weeks with continuous improvements in abstinence, depression, quality of life and medication satisfaction. In a qualitative research survey of 20 participants representing various practice settings, published in American Health & Drug Benefits, it was determined that telemedicine was the most common solution adopted during the COVID-19 pandemic to overcome access barriers. However, today there are still significant challenges in ensuring appropriate access to medications for those living with OUD and continued support, effective solutions and policies in the United States, need to be continually addressed. In a narrowly focused literature, policy, and legal proceedings review, published in Corrections Today, a clear disparity in access to MOUD was found between the general public and incarcerated individuals. Stigma and informed consent were the most discussed barriers used to justify policies limiting MOUD for incarcerated individuals. Presentations Multiple real-world evidence poster presentations highlight challenges and opportunities in treating persons with OUD. 2024 American Association of Psychiatric Pharmacists, April 7-10, Orlando FL Title: Emergency Room (ER) Visits Among Opioid Use Disorder (OUD) Patients Title: Opioid Treatment Programs, Healthcare Resource Utilization, and Healthcare Costs among Patients Initiating Treatment with Buprenorphine Extended-Release 2024 American Telemedicine Association Nexus, May 5-7, Phoenix AZ Title: Impact of Telemedicine on Medication for Opioid Use Disorder Retention during the SARS-CoV-2 Pandemic Period Among Patients with OUD 2024 College on Problems of Drug Dependence, June 15-19, Montreal Quebec Canada Title: Buprenorphine Treatment After an Emergency Department Visit for Non-Fatal Opioid Overdose Title: Pain Predicts Abstinence During Treatment of Opioid Use Disorder for Individuals Reporting Moderate to Severe Pain Title: A Randomized Open-Label Study Comparing Rapid and Standard Inductions to Injectable Buprenorphine Extended-Release (BUP-XR) Treatment Title: A Mechanistic Pharmacological Model to Predict and Inform Effective Buprenorphine Treatment Induction Strategies in the Era of Synthetic Opioids 2024 U.S. Public Health Service Scientific & Training Symposium, June 24-27, Jacksonville FL Title: Clinical and Treatment Characteristics of American Indian/Alaska Native Patients Managing Opioid Use Disorder Compared to the General US Population BUPE2024 – Buprenorphine in Medicine: Clinical and Public Policy Implications, August 5, Virtual conference Title: Healthcare Utilization and Costs Associated with Management of Opioid Use Disorder (OUD) within Residential Treatment Programs (RTP) and Office-Based Opioid Treatment Programs (OBOT) 2024 National Commission on Correctional Health Care (NCCHC) Annual, October 19-23, Las Vegas, NV Title: Outcomes Associated with Medications for Opioid Use Disorder in the Carceral System: A Systematic Literature Review Title: Diversion of Medications for OUD in the Criminal Justice System Dr. Christian Heidbreder, Ph.D., Chief Scientific Officer at Indivior, emphasized, "The collective evidence highlights the importance of access to Medications for OUD, such as SUBLOCADE, in reducing barriers to adherence and improving outcomes for individuals in recovery. Indivior is committed to continuing to advance the understanding of patients with OUD, educate on evidence-based practices, overcome stigma, and focus on recovery outcomes." Among the almost 6 million people aged 12 or older with a past year opioid use disorder in 2023, only 18% (or one million people) received treatment through MOUD.1 About SUBLOCADE® SUBLOCADE ® (buprenorphine extended-release) injection, for subcutaneous use, CIII INDICATION AND HIGHLIGHTED SAFETY INFORMATION INDICATION SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. SUBLOCADE should be used as part of a complete treatment plan that includes counseling and psychosocial support. HIGHLIGHTED SAFETY INFORMATION WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY Serious harm or death could result if administered intravenously. SUBLOCADE forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage, and thrombo-embolic events, including life threatening pulmonary emboli, if administered intravenously. Because of the risk of serious harm or death that could result from intravenous self-administration, SUBLOCADE is only available through a restricted program called the SUBLOCADE REMS Program. Healthcare settings and pharmacies that order and dispense SUBLOCADE must be certified in this program and comply with the REMS requirements. CONTRAINDICATIONS SUBLOCADE should not be administered to patients who have been shown to be hypersensitive to buprenorphine or any component of Indivior's proprietary buprenorphine gel depot delivery system. WARNINGS AND PRECAUTIONS Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory Depression: Life threatening respiratory depression and death have occurred in association with buprenorphine. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with SUBLOCADE. Opioids can cause sleep-related breathing disorders e.g., central sleep apnea (CSA), sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. Consider decreasing the opioid using best practices for opioid taper if CSA occurs. Strongly consider prescribing naloxone at SUBLOCADE initiation or renewal because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. Educate patients and caregivers on how to recognize respiratory depression and how to treat with naloxone if prescribed. Risk of Serious Injection Site Reactions: The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration, and necrosis. The likelihood of serious injection site reactions may increase with inadvertent intramuscular or intradermal administration. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off the opioid. Risk of Opioid Withdrawal With Abrupt Discontinuation: If treatment with SUBLOCADE is discontinued, monitor patients for several months for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to and during treatment. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine before injecting SUBLOCADE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. ADVERSE REACTIONS Adverse reactions commonly associated with SUBLOCADE (in ≥5% of subjects) were constipation, headache, nausea, injection site pruritus, vomiting, increased hepatic enzymes, fatigue, and injection site pain. For more information about SUBLOCADE, the full Prescribing information including BOXED WARNING, and Medication Guide, visit . About Opioid Use Disorder (OUD) Opioid Use Disorder (OUD) is a chronic disease in which people develop a pattern of using opioids that can lead to negative consequences.2 OUD may affect the parts of the brain that are necessary for life-sustaining functions.2,3 About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD), overdose and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit to learn more. Connect with Indivior on LinkedIn by visiting . References Substance Abuse and Mental Health Services Administration. (2024). Key substance use and mental health indicators in the United States: Results from the 2023 National Survey on Drug Use and Health (HHS Publication No. PEP24-07-021, NSDUH Series H-59). Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2023 National Survey on Drug Use and Health (samhsa.gov) National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Committee on Medication-Assisted Treatment for Opioid Use Disorder, Mancher, M., & Leshner, A. I. (Eds.). (2019). Medications for Opioid Use Disorder Save Lives. National Academies Press (US). Accessed October 30, 2023, from NIDA. 2022, March 22. Drugs and the Brain. Accessed October 30,2023, from SOURCE Indivior PLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

肥胖问题已成为全球挑战，正在给个人身体健康和社会医疗系统造成严重负担。伴随肥胖问题的日益突出和居民对体态、健康管理的认知提升，如何帮助肥胖症患者成功减重、改善肥胖相关合并症已成为全社会关注的焦点，千亿规模的减重市场也随之迅速扩大。 10月25日-10月27日，“第十一届中国医师协会外科学分会肥胖和代谢病外科学专家工作组学术年会暨湖南省医学会外科学专业委员会肥胖与代谢外科学组2024年学术年会”在湖南长沙举办，“硬镜之王”卡尔史托斯参与了此次会议，于10月21日-10月24日期间带来减重手术直播，以及10月25日-10月27日在展台展示包括减重与代谢外科完整解决方案在内的相关产品。 01 全球肥胖人数急剧上升 减重手术市场空间巨大且高速增长 根据世界卫生组织今年披露，地球上至少有八分之一的人患有肥胖症。而中国已成为世界上肥胖和超重人数最多的国家。 以上数据来源于2023年肥胖症防治及减重白皮书 根据中国超重与肥胖标准，我国成人超重或肥胖率已超过50%，这意味着每2个成年人中就有1个超重或肥胖；6~17岁儿童青少年的超重或肥胖率为19%，中国6岁以下儿童超重或肥胖率为10.4%。 据2021年《柳叶刀》杂志发布的数据，预计到2030年，中国成年人、学龄儿童和青少年以及学龄前儿童的超重或肥胖率可能分别达到65.3%、31.8%和15.6%，超重或肥胖的人数可能分别达到78995万、5892万和1819 万 。 肥胖症人口数量的迅速上升已经成为中国的一个主要公共卫生问题。超重和肥胖症会对健康造成严重影响，并引发一系列疾病，这些疾病会导致严重残疾和过早死亡。 据了解，由于过多脂肪组织的质量效应或其直接的代谢效应，肥胖与超过200种慢性病发生相关，包括糖尿病、脑卒中、冠状动脉疾病、高血压、呼吸系统疾病、阻塞性睡眠呼吸暂停、骨关节炎等，甚至还包括了多种肿瘤。 以上数据来源于2023年肥胖症防治及减重白皮书 2020年《柳叶刀》报道的一项长达11年以上的多中心、大型观察性研究结果显示，与正常体重成年人相比，2级肥胖症（BMI 35.0~39.9）患者中发生非复杂性共病和复杂性共病的风险分别增加了7倍和26倍；在3级肥胖症（BMI≥40kg/m²）患者中分别了增加12倍和34倍。 可见，肥胖并非单纯的体态问题，而是一种慢性病，仅靠控制饮食和增加运动达到减重目的是困难的，其防治应遵循常见慢性病的管理模式，以疾病的三级预防和治疗为基本原则。 《中国肥胖症防治及减重手术白皮书2023》提到，重度肥胖症患者应接受包括综合性生活方式干预、药物治疗和减重手术在内的积极治疗。 在多项观察性和前瞻性研究中，减重手术被证明在实现显著和持久的体重减轻方面优于饮食、运动。荟萃分析结果显示，减重手术的持续减重效果可维持10年以上。 减重与代谢手术治疗市场已逐渐成为一个可观的全球刚需市场。10月17日，国家卫生健康委办公厅发布的《肥胖症诊疗指南（2024年版）》中，减重与代谢手术治疗便是其中一大分类。 肥胖代谢外科历史由来已久，在全球发展已历经近70载，在中国于1982年起步探索。2000年腹腔镜减重手术的开展，标志着中国肥胖代谢外科作为一个外科学分支学科正式步入历史。 经历了前10年举步维艰的萌芽阶段，当前已迈进了微创减重手术治疗肥胖症与代谢和相关疾病时代。肥胖代谢外科在中国得到了快速的发展，且某些科学理念已处于国际领先水平。 长坡厚雪的减重赛道，吸引了医疗器械巨头纷纷垂青，其中“硬镜之王”卡尔史托斯便在该领域不断取得技术创新成果。 02 直击减重手术临床痛点 卡尔史托斯推出全方位减重“利器” 目前，国内近98%的肥胖患者选择腹腔镜手术作为肥胖的治疗方法，但需要指出的是，肥胖患者的脂肪层特别厚，一般的标准腔镜器械会给手术医生带来诸多不便，比如够不着组织等，越胖的患者，对加长器械的需求就越迫切。尤其是超大BMI患者，腹壁及内脏脂肪较多，对手术环境的要求就更为苛刻。 针对临床上减重手术多年存在的难点，卡尔史托斯带来“减重影像+腹腔镜器械+气腹机”产品组成的减重完整解决方案。从先进的影像产品线到辅助平台设备再到专科器械，卡尔史托斯可以为临床及患者提供完整的减重专科解决方案，化繁为简，专科专治，助力中国减重医疗事业发展。 其中影像产品方面，作为“硬镜之王”的卡尔史托斯充分发挥其技术优势，IMAGE1 S Rubina 影像系统将4K、3D成像技术与近红外荧光（NIR/ICG）成像技术融为一体，即通过一套主机和一根三合一电子镜即可呈现4K 清晰度的3D 成像，同时具备白光和四种荧光显影模式。 此外，除IMAGE1 S RUBINA外，针对减重患者的特殊体型，有不同尺寸的加长光学镜。IMAGE1 S Rubina 帮助术者更准确地辨识解剖结构、血管、神经等，帮助降低复杂手术的难度，提升手术效率，改善手术操作，推动更多复杂手术的普及。 同时，IMAGE1 S Rubina影像系统所配备的TIPCAM1 Rubina 4K 3D NIR/ICG 三合一电子镜可实现自动水平校准和自动180°翻转，在术者旋转内窥镜进行操作时能够实时校正图像，使得图像在术野范围内始终保持水平方向，令手术操作更灵活、更便捷、更高效。 NIR通过自身信息导航的优势，可以提高减重手术的精确性，便于切割线封闭完整性的检查及重要血管的分辨，同时他有利于观察吻合口的血供，使手术更加安全。 器械产品方面，针对肥胖患者腹部脂肪较厚的特点，卡尔史托斯的减重专科器械加长更专业，组合更全面。加长设计可以提高手术效率，满足肥胖患者腹腔内机械操作所需长度，满足各类肥胖患者的需求，适配性更广。同时有效避免因脂肪堆积引起的术野遮挡，增加术中的安全性。此外，减重专科的加长器械上含有数字标记，可以在手术中为医生提供尺度参考。 气腹机产品则专门为减重手术提供充气解决方案，ENDOFLATORR 50 气腹机拥有更大的流速、更精确的调节方式，气体流量可达50L/min，同时具备高速和高精度灌流两种模式，适应不同类型患者。在术中可以快速建立气腹，并且在术中对于气腹的维持可调节性更高，同时气体可加热，从而可以更加安全便捷的完成手术。 结语 自20世纪40年代起，卡尔史托斯便在制造内窥镜、医疗设备器械研发及生产领域享誉全球。经过近80年的发展，卡尔史托斯凭借其精湛的技术工艺和全球领先的创新水平，不断推动全球微创手术器械的发展，可提供涵盖手术室，日间诊疗，门急诊/呼吸内镜中心，培训中心四大业务领域从首至足的完整解决方案。相信卡尔史托斯推出的减重与代谢外科完整解决方案，也将推动减重治疗走向更好明天。

NEW YORK, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced seven presentations from across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2024, being held Oct. 29 - Nov. 2, 2024, in Boston, Massachusetts. Details for the presentations are as follows: Major Depressive Disorder Title: AXS-05 (Auvelity®) in Major Depressive Disorder: Pooled Data from Two Six-Week Controlled Trials (GEMINI and ASCEND)Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Craig Chepke, MD, SUNY Upstate Medical UniversityPoster Number: 171 Title: Effects of AXS-05 (Auvelity®) in Improving Anhedonia and Interest-Activity Symptoms of MDD and the Associated Improvements in Functional Impairment Presentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: 172 Title: Real-World Treatment Experiences and Expectations by Symptom Severity in Patients with Major Depressive DisorderPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Roger McIntyre, MD, Professor of Psychiatry and Pharmacology at the University of TorontoPoster Number: 198 Alzheimer’s Disease Agitation Title: Clinical Profile of AXS-05 in Treating Alzheimer’s Disease-Related Agitation: Results from The Phase 2/3 Development ProgramPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain HealthPoster Number: 45 OSA and Narcolepsy Title: Solriamfetol for Excessive Daytime Sleepiness in Patients with Narcolepsy and OSA Reporting Anxiety and Depression in the Real-World SURWEY StudyPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Ulf Kallweit, MD, Assistant Professor of Neurology at the University Witten/Herdecke, GermanyPoster Number: 20 Cognition Title: Effects of Solriamfetol on Cognition in Obstructive Sleep Apnea with Excessive Daytime Sleepiness and Impaired Cognition in the SHARP Clinical TrialPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, GermanyPoster Number: 92 Title: Effects of Solriamfetol on Cognition in Patients with Excessive Daytime Sleepiness Associated with Narcolepsy in the Real-World SURWEY StudyPresentation Date and Time: Thursday, Oct. 31, 1:30 - 3 p.m. and Friday, Nov. 1, 1:30 - 3 p.m. ETLead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, department of neurology, Johannes Gutenberg-University, Mainz, GermanyPoster Number: 164 About Axsome Therapeutics Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at www.axsome.com. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of the Company’s Sunosi® and Auvelity® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to the Company’s special protocol assessment for the MOMENTUM clinical trial; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the continued commercialization of Sunosi and Auvelity and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Investors:Mark JacobsonChief Operating Officer(212) 332-3243mjacobson@axsome.com Media:Darren OplandDirector, Corporate Communications(929) 837-1065dopland@axsome.com