Buprenorphine

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

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