Sleep Apnea, Central

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

Senior financial executive Ramzi Benamar joins leadership team as Chief Financial Officer Experienced board member, Chief Financial Officer and strategic consultant Gary Sender joins board of directors to Chair the Finance Committee Both appointments precede multiple value-creating catalysts, including Phase 3 results for AD109 as a first potential oral treatment for obstructive sleep apnea (OSA) CAMBRIDGE, Mass., Oct. 23, 2024 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company focused on discovery, development, and commercialization of first-in-class oral therapies that address the neuromuscular dysfunction of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced the appointments of Ramzi Benamar as Chief Financial Officer and Gary Sender to the Board of Directors and as Chair of the Finance committee. The strengthening of both the leadership team and Board of Directors brings decades of combined experience in critical functions, such as financial management, strategic planning, company capitalization, investor relations and corporate mergers and acquisitions. "We are pleased to welcome both Ramzi and Gary to Apnimed, as they bring proven leadership experience in leading-edge, science-driven companies, across a broad range of critical finance and strategic functions. I am confident their additions will help to continue to drive forward our financial strategy, deliver on key operational priorities, and build long-term shareholder value," said Larry Miller, MD, Chief Executive Officer of Apnimed. "These appointments come at a critical time, as we look forward to next year's Phase 3 clinical trial results for AD109 and preparation for its potential commercial launch as a once-nightly oral therapy for OSA." Mr. Benamar commented, "I am incredibly excited to join the Apnimed team during this transformational time for the company. With its ongoing, late-stage clinical development program for AD109 in OSA, a value generating joint-venture with Shionogi and a strong existing investor base, Apnimed is well-positioned to serve the needs of all stakeholders, and I look forward to contributing to the achievement of its next phase of growth." "Apnimed is in an excellent position to accelerate into the next stage of corporate development," noted Mr. Sender. "I am eager to contribute to the financial and strategic initiatives of the company and am confident in the organization's continued clinical and future commercial successes." About Ramzi Benamar, Chief Financial Officer Ramzi Benamar has over 25 years of experience in the biotech and pharma industry, where he has an extensive track record of supporting the development and commercialization of novel pharmaceutical products and serving in executive financial leadership roles in both public and private companies. Ramzi has led several rounds of financing as a CFO amounting to about $600M. He served as the CFO of BELLUS Health, where he contributed to the growth of the company toward its acquisition by GSK. Ramzi was also the CFO at DBV Technologies and Elucida, and Vice President and Head of Financial Planning and Analysis for Spark Therapeutics until its acquisition by Roche Holdings. Earlier in his career, Ramzi held numerous positions of increasing responsibilities in finance, strategy, and operations at various pharma companies including Shire, Johnson & Johnson, and Merck. He holds a bachelor's and master's degree in business administration from Temple University, and a master's degree from the University of the Sciences in Philadelphia (Saint Joseph's University). About Gary Sender, Independent Director and Chair of Finance Committee Gary Sender has extensive financial leadership experience across the biopharmaceutical industry, including serving on the board of directors of several public and private biotechnology companies. Mr. Sender joined the Board of Directors of both Schrödinger, Inc., and Harmony Biosciences when they were both private companies and currently Chairs both respective Audit Committees and the Schrödinger Compensation Committee. He currently Chairs the Audit Committee and serves on the Compensation Committee of iBio. Mr. Sender also joined the Board of Directors of Gennao Bio (Private) in September of 2021 and currently Chairs both the Audit and Compensation committees. In March 2021, Mr. Sender retired as the Chief Financial Officer of Nabriva plc. Prior to Nabriva, he was the Chief Financial Officer of Synergy Pharmaceuticals. Previously, Mr. Sender was the Senior Vice President of Finance for Shire plc, supporting its global commercial businesses and all functions of its specialty pharmaceuticals business. Prior to joining Shire, he was the Chief Financial Officer of Tengion, Inc. Earlier in his career, Mr. Sender held several increasingly senior finance-related roles, including a 15-year career at Merck & Co., Inc., most recently serving as Vice President and Controller for Merck's U.S. pharmaceuticals business. Mr. Sender earned his bachelor's degree in finance and management information systems from Boston University. He received his master's degree in industrial administration (MBA) with a concentration in Finance from Carnegie-Mellon University. About AD109 AD109 could be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the underlying neuromuscular cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective noradrenaline reuptake inhibitor (NRI). Their combined pharmacological synergy targets the root neuromuscular cause of OSA. AD109 is a once-nightly oral pill that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA. About Obstructive Sleep Apnea Obstructive sleep apnea is a serious chronic sleep-related breathing disease where the upper airway repeatedly collapses during sleep, causing intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. The impact of OSA spans age, sex, and body type—there is no single face of the disease. Every night, greater than 54 million people in the U.S. and 1 billion people worldwide with OSA stop breathing, exposing them to serious, long-term health risks. An individual with OSA can experience hundreds of sleep apnea events in a single night. Each sleep apnea event reduces blood oxygen levels and deprives cells of the energy they need to perform vital functions. Ultimately, failure to effectively treat OSA increases the risk of long-term health consequences and quality of life impacts, including daytime fatigue, impaired judgement, premature death, and severe and potentially life-threatening health complications, such as high blood pressure, cardiovascular disease, and type 2 diabetes. Yet, even after being diagnosed, the majority of people with OSA either refuse, abandon, or underutilize treatment. In addition, no currently available treatments address the underlying neuromuscular dysfunction present in all OSA cases. About Apnimed Apnimed is a pharmaceutical company dedicated to breathing new life into the sleep-related breathing disease treatment landscape. The company envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and elevate the health and expectations of everyone in the sleep-related breathing disease community. Based in Cambridge, Mass., Apnimed is advancing a focused pipeline of oral pharmaceutical product candidates designed to help improve oxygenation for people living with obstructive sleep apnea and beyond, to other sleep-related breathing diseases, including several that are part of our joint venture with Shionogi & Co., Ltd, Shionogi Apnimed Sleep Science (SASS). Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Brian Ritchie [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

66% of respondents said exhaustion from OSA affects their ability to be present with loved ones. Nearly 50% of respondents are unable to share a bed with their partners. 92% stated that OSA symptoms have impacted their work productivity in the last week 71% agree that OSA can make it difficult to cope with the daily stresses of life. Survey was conducted in consultation with sleep experts and people with OSA. Three national sleep advocacy organizations are collaborating with Apnimed to call for urgent attention to OSA by distributing the survey results across their networks. CAMBRIDGE, Mass., Oct. 9, 2024 /PRNewswire/ -- Apnimed, Inc., today announced the results of its Sleep Health Inquiries on Needs and Emotions (SHINE) survey of 1,500 people living with obstructive sleep apnea (OSA). The survey results revealed the significant and often devastating impact that people living with OSA experience daily. Many respondents reported feeling worn out or exhausted from fatigue, with 74% indicating this issue. Additionally, 67% feared long-term health consequences, while 34% expressed a fear of dying due to their OSA. The impact of OSA spans age, sex, race, ethnicity, and body type — there is no single face of the disease — and the survey revealed the considerable emotional, social, and behavioral burdens and stigma that negatively impact family dynamics, social relationships, self-esteem, and work productivity. Key findings include: 92% of respondents stated that OSA affects their work and 86% state OSA affects their ability to do other daily activities (e.g., childcare, chores, exercise, etc.) Younger people with OSA (aged 18-34) — who do not match the common stereotype of OSA affecting older individuals — reported struggling with low self-esteem (42%) and anxiety (54%) and 56% said OSA makes them feel misunderstood or isolated 57% of respondents shared that living with OSA negatively impacts their relationships with family and friends More than two-thirds (67%) of those surveyed reported feeling depressed or hopeless Full survey results and methodology can be viewed on OSASurvey.com OSA is a serious chronic sleep-related breathing disease, affecting more than 54 million people in the United States and nearly one billion worldwide. OSA is caused by two overlapping mechanisms: neuromuscular dysfunction and predisposing anatomic abnormalities. Failure to effectively treat OSA can impair daily function and increase one's risk for serious comorbidities like hypertension, diabetes, cardiovascular disease, and stroke. Yet, among the millions diagnosed, the majority of people with OSA refuse, abandon or underutilize existing treatment, underscoring the need for additional treatment options. "The SHINE survey has powerfully captured the voices and challenges faced by individuals living with OSA, a chronic illness that has failed to receive the public attention it deserves," said Monica P. Mallampalli, PhD, Executive Director, Alliance of Sleep Apnea Partners (ASAP), "The real-life experiences of living with OSA spotlighted in the results emphasize the need for greater awareness, both for the public and for healthcare providers, to improve recognition and management of this often-overlooked condition." The SHINE survey included consultation with sleep experts and patient advocacy organizations to ensure that the survey and its analysis accurately represented the experiences and viewpoints of the diverse OSA community. Three leading sleep health advocacy organizations collaborated with Apnimed to review the survey results and have joined forces to distribute these findings with their communities. The group includes Alliance of Sleep Apnea Partners (ASAP), American Sleep Apnea Association (ASAA), and Project Sleep. Apnimed, a clinical-stage pharmaceutical company focused on discovery, development, and commercialization of novel oral therapies for the treatment of OSA and other sleep-related breathing diseases, developed the SHINE survey to provide valuable insights to enable the sleep health community to better comprehend the psychosocial impacts of living with OSA and support people living with the disease. "We are incredibly proud to sponsor this groundbreaking survey, which shines a light on the significant challenges faced by those living with OSA," said Larry Miller MD, CEO of Apnimed. "This effort would not have been possible without the invaluable collaboration of advocacy organizations dedicated to sleep health. We drew on insights from many of their previous efforts such as the ASAA-led AWAKE initiative. Their commitment to raising awareness and advocating for better diagnosis and treatment of OSA is truly inspiring. Together, we are taking an important step toward making OSA a public health priority and ensuring that the voices of those affected are heard and supported." Visit OSAsurvey.com to read personal stories of four people living with OSA that shine further light on the challenges of this disease, as well as the full results of the survey. About Obstructive Sleep Apnea Obstructive sleep apnea is a serious chronic sleep-related breathing disease where the upper airway repeatedly collapses during sleep, causing intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. The impact of OSA spans age, sex, and body type—there is no single face of the disease. Every night, greater than 54 million people in the U.S. and 1 billion people worldwide with OSA intermittently stop breathing, exposing them to serious, long-term health risks. An individual with OSA can experience hundreds of these sleep apnea events in a single night. Each sleep apnea event reduces blood oxygen levels and deprives cells of the energy they need to perform vital functions. Ultimately, failure to effectively treat OSA increases the risk of long-term health consequences and quality of life impacts, including daytime fatigue, impaired judgement, premature death, and severe and potentially life-threatening health complications, such as high blood pressure, cardiovascular disease, and type 2 diabetes. Yet, even after being diagnosed, the majority of people with OSA either refuse, abandon, or underutilize treatment. In addition, no currently available treatments address the underlying neuromuscular dysfunction present in all OSA cases. About Apnimed Apnimed is a pharmaceutical company dedicated to breathing new life into the sleep-related breathing disease treatment landscape. The company envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and elevate the health and expectations of everyone in the sleep-related breathing disease community. Based in Cambridge, Mass., Apnimed is advancing a focused pipeline of oral pharmaceutical product candidates designed to help improve oxygenation for people living with obstructive sleep apnea and other sleep-related breathing diseases, including several that are part of our joint venture with Shionogi & Co., Ltd, Shionogi Apnimed Sleep Science (SASS). Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact: [email protected] Investor Contact: Brian Ritchie [email protected] SOURCE Apnimed, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED