The investigators plan to conduct an R61/33 hybrid type 2 implementation-effectiveness trial that includes 1) a one-year exploratory R61 phase that will enable the development of the intervention protocol needed for the R33 trial phase including concrete R61 phase milestones; 2) a four-year R33 phase that will include a concurrent implementation evaluation and a randomized control trial.

Start Date01 Nov 2025

Sponsor / Collaborator

Duke University

[+4]

NCT06574009

/ Not yet recruitingPhase 4IIT

Better Options for Chronic Cancer Pain: a SMART Study

This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.

Start Date01 Jul 2025

Sponsor / Collaborator

VA Office of Research and Development

ACTRN12625000385448

/ Not yet recruitingPhase 2

A Phase 2, Open-Label Trial Assessing the Feasibility of Direct Transfer from Methadone to CAM2038 (Buprenorphine) in Patients with Opioid Dependence

Start Date18 Jun 2025

Sponsor / Collaborator-

100 Clinical Results associated with Buprenorphine

100 Translational Medicine associated with Buprenorphine

100 Patents (Medical) associated with Buprenorphine

11,506

Literatures (Medical) associated with Buprenorphine

31 Dec 2025·ANNALS OF MEDICINE

Mindful moms: acceptability and impact of co-designed and digitally delivered video meditations for pregnant and parenting women with opioid use disorder

Article

Author: Lord, Sarah E. ; Rao, Deepika

INTRODUCTION:

Perinatal opioid use disorder (OUD) remains a public health epidemic. Stress, anxiety and depression are disproportionately high among this population and are associated with poor recovery outcomes. Mindfulness interventions show promise for supporting recovery for women. This paper reports results of a pilot study to evaluate initial efficacy and acceptability of digitally delivered mindfulness meditation videos to reduce stress and promote mindfulness among women in recovery.

METHODS:

Women with lived experience of OUD were recruited from three outpatient programs that provided care to pregnant and parenting women with a history of opioid use in rural northern New England (2 maternity care settings that offered buprenorphine as part of their service menu and 1 academic substance use treatment setting). In a pre-post study design, participants were randomly assigned to receive four of 16 short meditation videos, each delivered by email in a survey link over a 2-week period (2 per week) Videos were co-designed in earlier work with representative end-users, guided by evidence-based mindfulness interventions. Assessment included the Perceived Stress Scale and the Mindfulness Attention Awareness Scale. Participants rated each video on usefulness, enjoyability, ability to lower anxiety, and intention to use in the future. Participants also provided open-ended feedback about the videos. Data were analyzed using descriptive statistics, paired t-tests, and generalized linear modeling.

RESULTS:

A total of 20 women, ages 24-36 years, completed the pilot study. Most participants (95%) were white and non-Hispanic, reflecting the rural region. Marginal mean perceived stress scores decreased significantly from 21.49 to 19.85 [p = 0.05, d = 0.43] and mean mindfulness scores increased significantly from 3.47 to 3.76 [p = 0.04, d = 0.45]. Overall, the meditation videos were rated as highly acceptable and useful and a majority (80%) indicated intention to use the meditations in the future.

CONCLUSION:

Digitally delivered meditation videos were highly acceptable and useful to participants and the low dose intervention reduced stress and improved mindfulness. Findings inform directions for future research with larger samples to evaluate the effectiveness of this accessible digital intervention to support women in recovery and strategies for broadly implementing the intervention.

01 Aug 2025·AMERICAN JOURNAL OF EMERGENCY MEDICINE

Initiation of extended-release buprenorphine in emergency department patients: A retrospective cohort study

Article

Author: Marion-Bellemare, Louisa ; Kahan, Meldon ; Srivastava, Anita ; Wyman, Jennifer ; McGillis, Michaela ; Roy, Danielle Carole ; Samson, Julie

OBJECTIVE:

To determine the outcomes of emergency department (ED) patients with opioid use disorder (OUD) who were treated with high dose sublingual and subcutaneous buprenorphine and admitted to an inpatient withdrawal management unit (WiMU).

METHODS:

We conducted a retrospective chart review of patients with OUD who presented to the ED of the Timmins and District Hospital (TADH) and who had received high (minimum 16 mg, no upper bound) dose sublingual buprenorphine (SL bup), administration of 300 mg injectable extended-release buprenorphine (ER bup), and admission to the WiMu.

RESULTS:

Ninety patients met the inclusion criteria: the majority were fentanyl users (98 %) and Indigenous (61 %). There were no adverse events, including precipitated withdrawal, as a result of receiving high dose SL bup and ER bup. Treatment retention at 3, 6, and 12 months was 58 %, 44 %, and 36 % respectively. In the year following treatment initiation, there was a reduction in non-fatal overdoses (21.9 %, p = 0.0018), ED visits (78.1 %, p < 0.0001), and hospitalizations (77.1 %, p < 0.0001) compared to the year prior to treatment initiation.

CONCLUSIONS:

In patients with OUD presenting to a community ED, a treatment regimen of high dose SL bup and ER bup, and admission to a designated unit resulted in significantly reduced nonfatal overdoses, ED visits, and hospitalizations at one year.

01 Aug 2025·Journal of substance use and addiction treatment

Counseling as a complement to buprenorphine treatment for opioid use disorder: A retrospective observational study of patient outcomes

Article

Author: Hasan, Md Mahmudul ; Noor-E-Alam, Md ; Young, Gary J ; Zhu, Tianjie ; Young, Leonard D

INTRODUCTION:

This study investigated the clinical benefit of counseling as a complement to buprenorphine treatment for opioid use disorder (OUD). The research addresses a critical gap in understanding whether counseling, when received concurrently with buprenorphine, can enhance patient outcomes.

METHODS:

We conducted a retrospective cohort study using data from the Massachusetts Department of Public Health's Public Health Data Warehouse (PHD). The study included patients who initiated buprenorphine treatment between January 2015 and December 2019. Investigators measured outcomes including medication adherence, treatment discontinuation, and opioid-related overdose over a 12-month period. We evaluated the effectiveness of counseling based on whether patients attended a minimum of three sessions in the first three months of buprenorphine treatment. We employed multivariate logistic regression and propensity score matching to analyze the data.

RESULTS:

The study sample comprised 32,688 patients with 8871 (27 %) receiving counseling concomitantly with buprenorphine. Results from the regression analyses showed that counseling was associated with 17 % lower likelihood of poor medication continuity (OR = 0.83, 95 % CI = 0.78-0.87) and 21 % lower likelihood of treatment discontinuation (OR = 0.79, 95 % CI = 0.75-0.83). Counseling was not associated with the odds of opioid-related overdose. Additional results from sensitivity analyses pointed to a dose-response relationship for counseling within the parameters studied.

CONCLUSIONS:

Findings suggest that counseling, when combined with buprenorphine treatment for OUD is associated with better patient outcomes in terms of medication continuity and treatment retention. However, the impact of counseling on opioid-related overdose risk was inconclusive, highlighting the need for further research to understand its role in overdose prevention.

News (Medical) associated with Buprenorphine

01 May 2025

·www.prnewswire.com

New Study Highlights Monthly SUBLOCADE® as a Potential Treatment Option for Opioid Use Disorder During and After Pregnancy

SUBLOCADE use during pregnancy showed no increased risk of birth defects, miscarriage, or maternal complications compared to general population rates RICHMOND, Va., May 1, 2025 /PRNewswire/ -- Indivior PLC (Nasdaq/LSE: INDV) today announced the publication of a study "Monthly Buprenorphine Depot Injection (SUBLOCADE) for Opioid Use Disorder During Pregnancy" in the American Journal on Addictions, evaluating the use of SUBLOCADE for the treatment of opioid use disorder (OUD) during pregnancy and postpartum. Three sources of data evaluated in this retrospective study illustrated that the use of monthly SUBLOCADE during pregnancy demonstrated no increased risk and is consistent with the established buprenorphine safety profile.1 This retrospective study includes clinical case studies from four pregnant patients treated with monthly SUBLOCADE, postmarketing surveillance data covering more than five years, and a targeted literature review. In total, 322 reports of pregnancy exposures to SUBLOCADE were identified. Of the four patients included in the clinical practice case studies, all delivered full-term infants with normal birthweight, no fetal anomalies, and no need for treatment for neonatal opioid withdrawal syndrome (NOWS). "The findings shared in this manuscript support perinatal, patient-centered decision-making," said Melinda Ramage, FNP-BC, CARN-AP, LCAS, Director of the North Carolina Perinatal Substance Use Disorder Network and lead author of the publication. "Treatment is not one-size-fits-all, and it is important to explore safe and effective options for the mother–baby dyad." Between 2010 and 2017, opioid use during pregnancy dramatically increased, with a 131% increase in opioid use-related diagnoses at delivery in the U.S.2 The U.S. national maternal morbidity and mortality data reveal mental health and substance use disorders are the leading underlying cause of pregnancy-related deaths in 36 states. While pregnancy-associated overdose deaths have been steadily rising since 2007, those involving fentanyl and other synthetic opioids markedly increased from 5.73 to 9.47 deaths per 100,000 in a span of just 3 years (2017–2020), with most deaths occurring post-delivery.3 This study helps address the current knowledge gap with relevant experience from patients and prescribers who used monthly SUBLOCADE during pregnancy and/or postpartum. In addition to the case studies, the postmarketing surveillance data showed live births with no reported birth defects in the majority of known cases and rates of spontaneous abortion and other outcomes consistent with or lower than general population rates. Review of relevant literature also aligned with the findings from postmarketing and clinical data sources. These data highlight buprenorphine's established safety profile and offers practical insights into clinical care. "OUD patients who are pregnant run the risk of experiencing a number of negative health consequences, such as infection, overdose, severe maternal morbidity, postpartum readmission, and even death, and using opioids during pregnancy has been linked to poor results for both the fetus and the newborn," said Christian Heidbreder, Chief Scientific Officer at Indivior. "As public health professionals and policymakers look for ways to reduce maternal overdose deaths, this study offers important new information about how long-acting medications like SUBLOCADE might be incorporated into a broader strategy to increase access and enhance outcomes for families affected by OUD." Treatment decisions during pregnancy and postpartum should reflect a shared decision-making approach between providers and patients, aligning with clinical guidance and product labeling. The patient-centered model is especially critical when managing chronic conditions, like OUD, in the perinatal period. These data support consideration of using SUBLOCADE as part of evidence-based treatment options, which include offering or continuing perinatal medications for OUD, prioritizing patient stability when considering a change of existing pharmacotherapy in pregnancy and postpartum, and assessing the benefits and risks in a patient-centered framework. This is the largest amount of data available regarding the experience of pregnant patients on SUBLOCADE. Limitations of the study include limited descriptive data for case studies obtained from a small patient cohort and 21% of pregnancies reported outcomes for postmarketing surveillance. Disclosure: This work was funded by Indivior Inc., with the exception of the case studies and the time and contributions of Melinda Ramage, which were not supported by Indivior. 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 single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. 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 call 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 Hypersensitivity to buprenorphine or any other ingredients in SUBLOCADE. 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. Risk of Serious Injection Site Reactions: Likelihood of may increase with inadvertent intramuscular or intradermal administration. Evaluate and treat as appropriate. The most common injection site reactions are pain, erythema and pruritus with some involving abscess, ulceration and necrosis. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) 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 of 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 patients have tolerated 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. OUD may affect the parts of the brain that are necessary for life-sustaining functions. About Indivior Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD 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 expand on its heritage in this category. 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: Ramage M, Bishop B, Mangano V, Mankabady B. Monthly Buprenorphine Depot Injection (SUBLOCADE®) for Opioid Use Disorder During Pregnancy. Am J Addict. 2025. Hirai AH, Ko JY, Owens PL, Stocks C, Patrick SW. Neonatal abstinence syndrome and maternal opioid-related diagnoses in the US, 2010–2017. JAMA. 2021; 325(2): 146-155. doi:10.1001/jama.2020.24991 Bruzelius E, Martins SS. US trends in drug overdose mortality among pregnant and postpartum persons, 2017–2020. JAMA. 2022; 328(21): 2159-2161. doi:10.1001/jama.2022.17045 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

Clinical ResultClinical Study

10 Apr 2025

·www.prnewswire.com

Newborn Brains Are Smaller When Exposed to Opioids During Gestation

An important "first dive" into data from the 4-site Outcomes of Babies with Opioid Exposure (OBOE) study features a Cincinnati Children's expert as co-first author CINCINNATI, April 10, 2025 /PRNewswire/ -- When pregnant women take opioids during pregnancy, even opioids such as buprenorphine or methadone to treat opioid use disorder, the developing brains of their children can be significantly affected, according to a study published April 7, 2025, in JAMA Pediatrics. Continue Reading Antenatal opioid exposure is associated with smaller neonatal brain volumes, with varying impact depending on the type and number of exposures, according to research published in JAMA Pediatrics. Stephanie Merhar, MD, MS, at Cincinnati Children's was first co-author. Total brain volume was nearly 5% smaller among 173 newborns with antenatal opioid exposure compared to 96 unexposed newborns, based on magnetic resonance imaging (MRI) scans. More specifically, reduced volumes among opioid-exposed newborns occurred in cortical gray matter, deep gray matter, white matter, cerebellum, brainstem, and the right and left amygdala. There were notable differences in the location and scale of the effects, which varied depending on the type of opioid involved, and whether other drugs were also taken during pregnancy. "We have known for a while that children exposed to opioids during pregnancy are at risk of later developmental and behavioral problems, but it was hard to know whether that was due to the opioids themselves or other factors such as other exposures or lower birth weight," says co-first author Stephanie Merhar, MD, MS, a neonatologist at Cincinnati Children's. "This study was launched because we needed a large study where we were able to control for things like nicotine exposure and birth weight. Our next step is to follow the children in the study to see whether having smaller brain volumes in the newborn period affects later development and behavior." The double-threat opioids pose to mothers and children Nearly 1 in 12 newborns in the United States in 2020 – or about 300,000 infants – were exposed to alcohol, opioids, marijuana or cocaine before they were born, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Prenatal substance exposure in rural areas often exceeds overall national averages. Opioids include illegal drugs like heroin and fentanyl, prescription drugs like oxycodone and hydrocodone, and medications for opioid use disorder like buprenorphine and methadone. Opioid use often goes hand in hand with smoking and use of other substances such as alcohol and marijuana. This study compared newborns born to mothers who took opioids only and newborns born to mothers who used other substances as well as opioids. Newborns exposed to opioids plus other substances had smaller brain volumes in more regions compared to those exposed to opioids only. The most common opioids among participants in the new study were buprenorphine (68.8%) and methadone (26%). Both of these opioids are routinely used to treat opioid use disorder (OUD) and are both recommended for treatment of OUD during pregnancy by the American College of Obstetricians and Gynecologists. "We know that buprenorphine and methadone are life-saving medications for women with OUD," Merhar says. "We don't want to imply that women with OUD should wean off these medications, but we agree with the ACOG recommendation for more research on medically supervised withdrawal in pregnant women." The study was praised in an accompanying editorial penned by Nethra Madurai, MD, and Lauren Jantzie, PhD, both of Johns Hopkins University School of Medicine. Other small studies have shown fetal brain changes caused by opioids. But this multi-center study is the first to be large enough to convincingly distinguish effects linked to opioids versus confounding factors such as maternal smoking, birth weight, education levels. The study authors "present compelling evidence of the direct effects of opioids on the developing brain," the editorial states. "Given the prospective design of the trial, they account for other postnatal factors…allowing us to dispel previous uncertainty surrounding the direct impacts of opioids on the brain vs the confounding effects of other environmental factors." What's next? Having more precise information about the affected parts of the brain could allow scientists to focus on interventions to support healthy brain development for children born after opioid exposure. "Indeed, we must shift our focus beyond the initial withdrawal symptoms associated with POE [prenatal opioid exposure] if we are to improve the lifelong health and well-being of infants and children impacted by the opioid epidemic," the editorial states. Read more about Merhar's research related to opioid exposure: 'Eat, Sleep, Console' Approach Slashes ICU Stays for Opioid-Exposed Newborns In Utero Opioid Exposure Impacts Fetal Brain Size and Development $8M Grant Funds Long-Term Opioid Exposure Study SOURCE Cincinnati Children's Hospital Medical Center WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

07 Apr 2025

·www.prnewswire.com

Viatris Statement on Nationwide Settlement to Resolve Opioid-Related Claims

PITTSBURGH, April 7, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS) (the "Company") today announced it has reached a nationwide settlement framework to resolve opioid-related claims by states, local governments, and Tribes against the Company and certain of its subsidiaries. While the Company's presence in the U.S. opioids market is very small, the Company has agreed to this settlement to provide closure on these matters. This settlement is in no way an admission of wrongdoing or liability. Under the agreed upon framework, depending on the level of participation in the settlement, the Company would pay up to a maximum of $335 million, consisting of annual payments over a nine-year period of between approximately $27.5 and $40 million each, to help support state and local efforts to address opioid-related issues. The Company had already accrued an estimate in respect of a potential settlement, which is reflected in the Company's annual report on Form 10-K for the year ended December 31, 2024. The Company will also continue its longstanding role of working to identify solutions to address pressing public health challenges like those relating to opioids. For example, the Company manufactures a generic injectable version of the life-saving overdose reversal drug, naloxone, as well as a generic buprenorphine/naloxone product used for the treatment of opioid addiction. The Company is also developing a novel delivery for meloxicam, a non-opioid pain medication. The settlement enables the Company to further focus on its mission of empowering people worldwide to live healthier at every stage of life, advance its efforts to address unmet patient needs through an expanded innovative portfolio and continue to serve approximately 1 billion patients annually with its diverse portfolio of medicines. About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter). Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding the Company's nationwide settlement framework to resolve opioid-related claims by states, local governments, and Tribes against the Company and certain of its subsidiaries; under the agreed upon framework, depending on the level of participation in the settlement, the Company would pay up to a maximum of $335 million, consisting of annual payments over a nine-year period of between approximately $27.5 and $40 million each, to help support state and local efforts to address opioid-related issues; that the Company will also continue its longstanding role of working to identify solutions to address pressing public health challenges like those relating to opioids; the Company is also developing a novel delivery for meloxicam, a non-opioid pain medication; and that the settlement enables the Company to further focus on its mission of empowering people worldwide to live healthier at every stage of life, advance its efforts to address unmet patient needs through an expanded innovative portfolio and continue to serve approximately 1 billion patients annually with its diverse portfolio of medicines. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the inability or unwillingness on the part of any of the parties to agree to a final settlement; any legal or regulatory challenges to the settlement; the level of participation by litigants or claimants in the settlement framework; any failure by third parties to comply with their contractual obligations; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, tariffs and trade policies, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

100 Deals associated with Buprenorphine

External Link

KEGG	Wiki	ATC	Drug Bank
D07132	Buprenorphine	N07BC01	DB00921

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Opioid-Related Disorders	United States	Braeburn, Inc.	23 May 2023
Opium Dependence	European Union	Camurus AB	20 Nov 2018
Opium Dependence	Iceland	Camurus AB	20 Nov 2018
Opium Dependence	Liechtenstein	Camurus AB	20 Nov 2018
Opium Dependence	Norway	Camurus AB	20 Nov 2018
Opioid abuse	United States	Indivior, Inc.	30 Nov 2017
Pain	United States	Purdue Pharma LP	13 Oct 2017
Chronic Pain	United States	Purdue Pharma LP	30 Jun 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cancer Pain	Phase 3	China	LTS LOHMANN Therapie-Systeme AG	10 Jun 2019
Cancer Pain	Phase 3	China	Grünenthal GmbH	10 Jun 2019
Cancer Pain	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	10 Jun 2019
Analgesia	Phase 3	-	Purdue Pharma LP	01 Nov 2011
Pain, Postoperative	Phase 3	-	Purdue Pharma LP	01 Nov 2011
Intervertebral Disc Disease	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Aug 2009
Musculoskeletal Pain	Phase 3	China	Beijing Mengdi Pharmaceutical Co. Ltd.	01 Aug 2009
opioid dependence methadone	Phase 3	United States	Titan Pharmaceuticals, Inc.	01 Sep 2008
Osteoarthritis, Spine	Phase 3	United States	Purdue Pharma LP	01 Apr 2004
Osteoarthritis, Knee	Phase 3	United States	Purdue Pharma LP	01 Jun 1999

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02651584 (PRNewswire) Manual	Phase 3	Opioid-Related Disorders	123	BRIXADI (fentanyl-positive)	yslgbemnwi(nytcphjote) = isepynsice novjllmvsg (ezxhgnvjhw ) View more	Positive	25 Jun 2024
				buprenorphine + naloxone (fentanyl-positive)	yslgbemnwi(nytcphjote) = btpfiokvmg novjllmvsg (ezxhgnvjhw ) View more
NCT02651584 (Pubmed)	Phase 3	fentanyl-positive \| norfentanyl	428	Subcutaneous Buprenorphine	rgmgsofjrn(timjjqbtos) = kniyptzpcv twqgrlzrbk (blggezougm )	Positive	03 Jun 2024
				Sublingual Buprenorphine-Naloxone	rgmgsofjrn(timjjqbtos) = eghhxngjcx twqgrlzrbk (blggezougm )
NCT02651584 (FDA) Manual	Phase 3	Opioid-Related Disorders	428	BRIXADI	brznwactdm(byjojcwydm) = jnutseaglv fxkmkbyvsm (jknqjgikwh ) View more	Positive	23 May 2023
				buprenorphine/naloxone	brznwactdm(byjojcwydm) = nlorpkqhtp fxkmkbyvsm (jknqjgikwh ) View more
NCT02611752 (FDA) Manual	Phase 2	Opioid-Related Disorders	47	BRIXADI	nrzjcvnexd(ddaajzulag) = No active intramuscular hydromorphone dose resulted in a mean drug liking VAS Emax score of 11 mm or greater when compared to placebo bywgxyettp (dzgrquxmfs )	Positive	23 May 2023
				Placebo
NCT02543944 (GBN, CTgov)	Phase 2/3	Unspecified drug dependence	117	Naltrexone (depot)+Buprenorphine+Clonidine+Gabapentin+Naltrexone (oral) (Gabapentin)	duadmnumst(chvhzhhylr) = nhqszmwaqn ahovzfbsli (posvhjimwg, 36.7) View more	-	28 Jul 2022
				Placebo+Naltrexone (depot)+Buprenorphine+Clonidine+Naltrexone (oral) (Placebo)	duadmnumst(chvhzhhylr) = rksitmxtuo ahovzfbsli (posvhjimwg, 38.5) View more
NCT03818399 (VOTIVE, CTgov)	Phase 3	Opiate Overdose \| Opioid abuse	19	SUBLOCADE	xhvnaoiddf = vsykuweges otnwwlshjc (icbfhykkfk, zzraoeoscn - bkvsngkxsr) View more	-	05 May 2022
NCT03608696 (B-PHORE, CTgov)	Phase 1/2	Neonatal Abstinence Syndrome	10	Buprenorphine	swekbuazxq(cxwrxrqmen) = mibsbbhfxb igoccyqhcj (ypgxmnqswr, kbmffdljev - alfehbqqjt) View more	-	11 Feb 2022
NCT03604159 (CTgov)	Phase 4	Opium Dependence	52	Buprenorphine Extended Release (Buprenorphine Extended-Release)	ackinpjpsy = zewjrdrbjb gmuryxrhtc (zmqjlwverl, tvqixjgsje - koeftnfagd) View more	-	11 Jan 2022
				Zubsolv+Buprenorphine (Sublingual Buprenorphine)	ackinpjpsy = ylrnccezkc gmuryxrhtc (zmqjlwverl, tizhehgzgw - trwmwrimqq) View more
NCT02891798 (CTgov)	Phase 3	Pain	98	Bupivacaine Only (control arm)	wsntguzymt(arhbjbqauc) = mkadiaxwxd shiklqfmqs (myzzklnoxn, 2.38) View more	-	20 Dec 2021
NCT02891798 (Pubmed \| Pain Med)	Phase 3	-	98	BPV-BCD	pqcmpqcshy(hjeeqpwero) = nrlrqjznex efyblhkovc (utxicwerhn, 0.6 - 3.0)	-	03 Nov 2021

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