Opioid abuse

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

OX640 is an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine. OX640 is based on Orexo´s proprietary drug delivery platform, AmorphOX®, and has demonstrated positive data in a phase 1 clinical study in healthy volunteers. The new study will investigate the performance of OX640 in participants with allergic rhinitis. UPPSALA, Sweden, Oct. 25, 2024 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the first participants have been dosed with OX640, an intranasal rescue medication for severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine, in a new study in subjects with allergic rhinitis (hay fever). The study will be completed during 2024 with results available early in 2025. Following the positive results from the phase 1 clinical study, OX640-001, where OX640 showed absorption of epinephrine and effects on blood pressure and heart rate equivalent to an epinephrine intramuscular auto-injector, Orexo now advances the development of OX640. In the new study, OX640-002, the epinephrine absorption from OX640 will be investigated in participants with and without allergic symptoms in the nose. As patients may experience allergic symptoms in the nose during anaphylaxis, it is critical to understand the absorption of epinephrine from Orexo's unique powder formulation under these conditions. The study is a cross-over study in 30 participants with allergic rhinitis and involves four treatment periods. In one of the periods, a small dose of an allergen will be sprayed into the nose of the participants to trigger an allergic reaction before being treated with OX640. This will be compared with absorption of epinephrine from OX640 without the allergen, and a commercial intramuscular epinephrine product. The fourth period will be used to document dose proportionality of OX640. In addition to the absorption of epinephrine, effects on blood pressure and heart rate will be measured as relevant parameters to understand the effect of OX640 in case of an anaphylaxis. Robert Rönn, SVP and Head of R&D, said: "Anaphylaxis is a serious and life-threatening condition, making it essential to ensure that OX640 remains effective even in the presence of nasal allergic symptoms. The study addresses key development and regulatory requirements and is an important step in advancing the project towards regulatory approval. The performance of OX640 under allergic rhinitis conditions has also been requested in many discussions with health care providers and with potential partners." The study is expected to cost SEK 11 million. Most of these costs will be recognized in 2024 and are included in the communicated financial outlook for 2024. For further information: Robert Rönn, SVP and Head of R&D Lena Wange, IR & Communications Director Nikolaj Sørensen, President and CEO Tel: +46 (0)18 780 88 00 E-mail: [email protected] About AmorphOX ® Orexo's proprietary drug delivery platform, AmorphOX, is a powder made up of particles which are built using a unique combination of a drug, carrier materials and, optionally, other ingredients. The particles are presented as an amorphous composite of the various ingredients providing for excellent chemical and physical stability, as well as rapid dissolution. The technology works for a broad scope of active ingredients and has been validated in several human clinical studies showing rapid and extensive drug exposure. About OX640 OX640 is an intranasal rescue medication for the treatment of severe allergic reactions (incl. anaphylaxis) with powder-based epinephrine. The product is based on Orexo´s proprietary drug delivery platform AmorphOX providing rapid and extensive systemic drug absorption after nasal administration as well as excellent physical and chemical stability. Thanks to its unique properties, OX640 has the potential to provide allergic patients with a needle-free, convenient, and rapidly acting allergy rescue product that also has long shelf-life and allows for flexible storage, both in hot and cold temperatures. About OX640-001 OX640-001 is a randomised sequence, single-centre, open label, 5-period crossover, phase 1 comparative bioavailability study with the primary objective to determine the relative bioavailability and absorption characteristics of four investigational formulations of OX640 versus an intramuscular auto-injector of epinephrine. About Orexo Orexo is a Swedish pharmaceutical company with 30 years of experience developing improved pharmaceuticals based on proprietary formulation technologies that meet large medical needs. On the US market, Orexo provides innovative treatment solutions for patients suffering from opioid use disorder and adjacent diseases. Products targeting other therapeutic areas are developed and commercialized worldwide with leading partners. Total net sales in 2022 amounted to SEK 624 million, and the number of employees to 126. Orexo is listed on Nasdaq Stockholm's main list and is available as an ADR on OTCQX (ORXOY) in the US. For more information about Orexo please visit, . You can also follow Orexo on X, LinkedIn, and YouTube. The information was submitted for publication at 3 pm CET on October 25, 2024. This information was brought to you by Cision . 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The newly released data highlights an increase in people seeking treatment – particularly among older adults – and reveals alcohol and opioid use disorders are the leading diagnoses at admission to Gaudenzia treatment centers. Regional data further emphasizes the need for culturally competent care and expanded access to evidence-based treatments for stimulant and opioid use disorders across PA, MD, DE, and D.C. PHILADELPHIA, Oct. 24, 2024 /PRNewswire/ -- Gaudenzia, Inc., one of the country's largest nonprofit treatment providers for people with substance use disorder (SUD) and co-occurring conditions, released its 2024 annual FrontLine Report today. The FrontLine Report is the only annual, comprehensive and data-driven look at SUD trends, county-by-county, in the Mid-Atlantic region where Gaudenzia operates over 50 facilities and provides over 120 licensed treatment programs to more than 15,800 admissions. Continue Reading Dr. Deja Gilbert, President and CEO of Gaudenzia, unveils the 2024 FrontLine report during a press conference in Philadelphia at Gaudenzia’s West Mill Place facility. First launched in 2021, the report highlights Gaudenzia's ongoing efforts to provide a full continuum of care for SUD and expand treatment accessibility while spotlighting emerging trends in SUD care across Pennsylvania, Maryland, Delaware, and Washington, D.C. The report was unveiled today by Gaudenzia leadership at a news conference in Philadelphia. Key findings from the 2024 FrontLine report include: Increased Treatment Admissions: Admissions to Gaudenzia's treatment programs increased by 5 percent to 15,855 from 15,045 in FY-23. Growth in Older Adult Admissions: The number of adults aged 55 and older seeking treatment increased by 3 percent in FY-24, for a total increase of 8 percent over FY-22. High Prevalence of Mental Health Diagnoses: 70.3 percent of individuals completing biopsychosocial assessments reported a past mental health diagnosis. Alcohol and Opioid Use Disorder Lead Diagnoses: Both alcohol use disorder and opioid use disorder remain the leading diagnoses at admission at 31 percent each. "Our 2024 FrontLine report offers valuable insight to what we are experiencing at a local level at our facilities and highlights the vital necessity to improve access to lifesaving and life-changing treatments for the millions of Americans struggling with addiction," said Dr. Deja Gilbert, President and CEO of Gaudenzia. "At Gaudenzia, we understand that access to evidence-based SUD treatment looks different depending on who you are, where you live, and who you are responsible for. By collaborating with the community, policymakers, advocates, families and other partners we will be able to create more avenues to treatment, eliminate barriers to care, and provide evidence-based care to make a difference in thousands of lives every day." While Gaudenzia saw increased admissions to its treatment programs, the Substance Abuse and Mental Health Services Administration (SAMHSA) notes that over 94 percent of individuals over the age of 18 with a SUD did not receive or seek treatment in 2023 – emphasizing more work needs to be done to ensure individuals receive available treatment. "We need to understand why so many people struggling with SUD are not getting the treatment they need," continued Dr. Gilbert. "By evaluating data, we can identify addressable barriers to care including lack of transportation, treatment options, and financial need." Increasing access to evidence-based care is a priority for Gaudenzia, whose mission is to promote long-term recovery regardless of individual circumstances. This includes: Meeting the Needs of Women and Families Since 1979, Gaudenzia has been a pioneer in offering SUD treatment specifically designed for women with children, such as family-centered treatment programs like the Claymont Center for Pregnant and Parenting Women, the only treatment program of its kind in Delaware. In 2023, the cohort of women served at Claymont was primarily between the ages of 25-44, with nearly 60 percent reporting an opioid use disorder – underscoring a significant need for medications for opioid use disorder access for pregnant and parenting women. Addressing Barriers to Access To increase access for more individuals, Gaudenzia has implemented several new programs, including the launch of Driving Recovery for PA, Pennsylvania's only mobile licensed narcotic treatment program and the introduction of open-access treatment models at key sites. The FrontLine report also affirms an industry-wide trend of significant racial disparities in access to medication-assisted treatment (MAT). Research shows that MAT is an effective approach in treating SUD that reduces relapse and overdose rates, but white clients were prescribed MAT at more than twice the rate of Black patients in both the six months before and after a SUD-related health emergency. Gaudenzia continues to address this disparity by advocating for equitable treatment options, working to repair relationships with the communities we serve, and providing culturally competent care and harm reduction services. Providing Complex Care Through Innovative Solutions Gaudenzia has seen an uptick in admissions of adults over the age of 55 for the second consecutive year – which reflects the national trend of overdose deaths among adults over the age of 65 quadrupling over the last two decades. Gaudenzia is urging for Medicare reforms to expand coverage of SUD treatment, improve access to MAT, and expand coverage to include community-based treatment settings. The 2024 report data also shows that polysubstance use remains common, with 45 percent of individuals with a secondary SUD reporting a stimulant use disorder. Gaudenzia is expanding its usage of the Matrix Model, a treatment approach designed to treat stimulant use disorder by integrating multiple evidence-based therapies to provide individualized care. Offering Housing as Healthcare Integration Access to stable housing remains a critical component of recovery. In FY-24, Gaudenzia served 2,813 individuals through its emergency, transitional, and permanent supportive housing programs. The report also highlights how Gaudenzia treatment centers serve a diverse client base across various demographics, including gender, age, and race/ethnicity in various counties and programs. Out of more than 15,800 admissions served across the organization, 44 percent of admissions served were white, 42 percent were Black/African American, 6 percent were Hispanic, and 6 percent were Multiracial. The county-by-county data in the FrontLine Report comes as the CDC reported 107,543 drug overdose deaths in the calendar year 2023. To access the complete FrontLine Report, visit . More information on Gaudenzia's evidence-based treatment programs for people with substance use and co-occurring disorders can be found at . Those who are in need of treatment can call Gaudenzia's 24/7 Treatment and Recovery Helpline at 833-976-HELP (4357). ABOUT GAUDENZIA, INC. Gaudenzia, Inc. is one of the largest nonprofit providers of treatment for people with substance use and co-occurring disorders in the United States, with 51 facilities operating in Pennsylvania, Maryland, Delaware, and Washington, D.C. The agency serves about 15,000 individuals annually and operates 120 programs providing a full continuum of care. Since 1968, Gaudenzia has provided specialized services and programs for all demographics, including pregnant and parenting women, adolescents, people with substance use and co-occurring disorders, and more. Those seeking help can call Gaudenzia's 24/7 Treatment and Referral HelpLine at 833-976-HELP (4357). For more information, visit . SOURCE Gaudenzia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED