Constipation

iStock, Ahmad Darmansyah The FDA accepted Novo Nordisk’s NDA for an oral formulation of Wegovy. The agency is expected to release its verdict on the drug in the fourth quarter of this year. The FDA on Friday accepted Novo Nordisk ’s New Drug Application for an oral formulation of its widely popular obesity drug Wegovy for chronic weight management, bringing the Danish drugmaker one step closer to winning the first regulatory approval for a GLP-1 pill specifically for weight-loss. Novo did not provide a specific target action date for oral Wegovy, only announcing in its news release that the FDA’s verdict is expected in the fourth quarter. If approved, Wegovy’s pill form will carry a 25-mg dose of the drug, scheduled for once-daily dosing in adults who are overweight or obese and who have at least one comorbid condition. Supporting Wegovy’s oral bid are results from the Phase III OASIS 4 study. A November 2024 readout showed that daily oral Wegovy could match the weekly injectable in lowering bodyweight, Healio reported at the time. Novo did not provide additional data comparing oral versus injectable Wegovy in its Friday release. OASIS 4 also found that oral Wegovy significantly outperformed placebo, cutting an average of 13.6% of participants’ weight, as opposed to 2.4% in the control group. The oral drug also had a safety pro with its injectable formulation. Wegovy can cause adverse effects like nausea, diarrhea, constipation and abdominal pain. Last month, a Novo spokesperson confirmed to BioSpace that the pharma had filed for approval for oral Wegovy. The spokesperson also clarified that Novo already has an oral GLP-1 on the market. Rybelsus, an early brand of semaglutide, was given the FDA’s go-ahead in September 2019 for oral dosing. But instead of being indicated for chronic weight management, Rybelsus is approved to treat type 2 diabetes. Novo is locked in a close race with Eli Lilly to bring the first weight-loss pill to the market. Last month, Lilly announced that orforglipron, an orally available GLP-1 treatment, significantly lowered blood glucose levels in patients with type 2 diabetes. Analysts at the time were bullish about these findings, with BMO Capital Markets noting that orforglipron achieved “injectable like efficacy.” Study participants also lost 7.9% body weight after orforglipron treatment, as compared with 1.6% in placebo. A few days after the late-stage win, Lilly CEO David Ricks told Fox Business that while the study was primarily in diabetes, the pharma’s first drug application for orforglipron will be for chronic weight management later this year. Lilly will subsequently approval for type 2 diabetes in 2026. The company also promised to manufacture the drug in the U.S.

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

Results of part 1 of the ESSENCE phase 3 trial, published in The New England Journal of Medicine, demonstrated that a greater proportion of patients with MASH achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to placebo. Patients with MASH also saw statistically significant and superior improvement in liver fibrosis with no worsening of steatohepatitis compared to placebo1 Approximately one in 20 people in the US are living with MASH.2 Left untreated, MASH can progress to serious and even fatal outcomes, such as cirrhosis, liver cancer, and the need for liver transplant3 Additionally, Novo Nordisk's application for Wegovy® (semaglutide) injection 2.4 mg for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) was recently accepted by FDA and granted Priority Review PLAINSBORO, N.J., April 30, 2025 /PRNewswire/ -- Today, The New England Journal of Medicine (NEJM) published results from part 1 of the ongoing phase 3 ESSENCE trial which investigated the effects of once-weekly subcutaneous semaglutide 2.4 mg on liver histology compared to placebo at 72 weeks in adults with MASH and moderate to advanced liver fibrosis (stage 2 or 3). At Week 72, the first primary endpoint showed 62.9% of people treated with semaglutide 2.4 mg achieved resolution of steatohepatitis with no worsening of liver fibrosis compared to 34.3% on placebo with estimated difference in responder proportions (EDP) of 28.7% (95% CI, 21.1 to 36.2; P<0.001). For the second primary endpoint at Week 72, 36.8% of people treated with semaglutide 2.4 mg achieved improvement in liver fibrosis with no worsening of steatohepatitis compared to 22.4% on placebo (EDP, 14.4%; 95% CI, 7.5 to 21.3; P<0.001).1 "ESSENCE part 1 demonstrates the effects of semaglutide 2.4 mg on the key histological elements, which may reduce disease progression to cirrhosis and end-stage liver disease," said Arun Sanyal, MD, lead author, principal investigator, and Director, Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University. "This is crucial, given the strong link between MASH and other cardiometabolic conditions." A confirmatory secondary endpoint at Week 72 showed 32.7% of patients treated with semaglutide 2.4 mg achieved both resolution of steatohepatitis and improvement in liver fibrosis compared to 16.1% of patients on placebo (EDP, 16.5%; 95% CI, 10.2 to 22.8; P<0.001).1 Furthermore, Novo Nordisk also announced that the US Food and Drug Administration has accepted the supplemental New Drug Application (sNDA) and granted Priority Review for Wegovy® (semaglutide) injection 2.4 mg to treat noncirrhotic MASH in adults with moderate to advanced liver scarring (fibrosis). Priority review designation means that FDA will review the application in six months, rather than the standard nine-month review period. "Novo Nordisk continues to explore semaglutide across metabolic and cardiovascular health including MASH, a condition with limited treatment options for patients and healthcare professionals," said Anna Windle, PhD, senior vice president of Clinical Development, Medical & Regulatory Affairs at Novo Nordisk. "We are encouraged by these published findings in the NEJM and what this could mean for patients. Based on these data, we look forward to working with regulatory authorities to bring this potential new treatment option to patients." Non-invasive tests (NITs) are valuable in supporting the screening of people at risk of developing MASH and may address early MASH detection. Implementing NITs may allow for fibrosis risk stratification earlier in the disease progression journey.4,5 The expanded analysis of ESSENCE showed apparent improvements of pre-specified NITs, including vibration-controlled transient elastography (VCTE), the Enhanced Liver Fibrosis (ELF)™ test, and PRO-C3, in adults treated with semaglutide 2.4 mg compared to placebo. These were supportive secondary endpoints, not controlled for multiplicity.1 Safety endpoints in the ESSENCE trial included adverse events and laboratory assessments. By Week 72, 88% of participants received and maintained the full target dose of semaglutide 2.4 mg. No new safety signals emerged, and the safety profile was consistent with the vast body of evidence for semaglutide. The most common adverse events were gastrointestinal-related, including nausea (36.3% semaglutide; 13.2% placebo), diarrhea (26.9% semaglutide; 12.2% placebo), constipation (22.3% semaglutide; 8.4% placebo), and vomiting (18.6% semaglutide; 5.6% placebo). Adverse events leading to trial discontinuation were 2.6% for the semaglutide group and 3.3% for the placebo group.1 Semaglutide 2.4 mg is not approved in the US for the treatment of MASH. About ESSENCE ESSENCE is a phase 3 trial evaluating the effect of once-weekly subcutaneous semaglutide 2.4 mg in adults with metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis (stage 2 or 3). It is a two-part trial where an estimated 1,200 planned participants are randomized 2:1 to receive semaglutide 2.4 mg or placebo, on top of standard of care for 240 weeks. Lifestyle counseling and management of coexisting diseases were recommended in alignment with guidelines. In part 1, the objective was to demonstrate that treatment with semaglutide 2.4 mg improves liver histology compared with placebo at 72 weeks based on biopsy sampling from the first 800 randomized patients. In part 2, which is ongoing, the objective is to demonstrate that treatment with semaglutide 2.4 mg lowers the risk of liver-related clinical events compared to placebo in adults with MASH and moderate to advanced liver fibrosis at 240 weeks.1,6 About semaglutide 2.4 mg Semaglutide injection 2.4 mg is previously approved along with a reduced calorie diet and increased physical activity, for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off and to reduce the risk of major CV events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.7 It is important to note that semaglutide injection 2.4 mg contains a Boxed Warning for possible thyroid tumors, including cancer and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).7 Semaglutide is not approved for the treatment of adults with MASH. Safety and efficacy are not established, and there is no guarantee that semaglutide will become commercially available for this use under clinical investigation. About Metabolic Dysfunction-Associated Steatohepatitis (MASH) MASH is a chronic, progressive metabolic disease affecting the liver, which can be potentially life-threatening if not properly managed.8,9 Among people who are living with overweight or obesity, approximately one in three also have MASH.10 Excess fat can build up in the liver, which, over time, can lead to inflammation and severe scarring of the liver.11 People living with MASH often experience few or no specific symptoms in the early stages of the disease, which often results in a delayed diagnosis.12 Approximately, one in 20 people in the United States are living with MASH.2 The disease progresses to cirrhosis in an estimated 20% of cases.13 MASH is a leading cause of cirrhosis in adults in the US, and MASH-related cirrhosis is the second indication for liver transplants in the country.14 About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X. Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com. Contacts for further information References Sanyal AJ, Newsome PN, Kliers I, et al. Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis. New Eng J Med. 2025;392(17). doi:10.1056/NEJMoa2413258 Younossi ZM, Mangla KK, Chandramouli AS, et al. Estimating the economic impact of comorbidities in patients with MASH and defining high-cost burden in patients with noncirrhotic MASH. Hepatol Commun. 2024;8:e0488. doi:10.1097/HC9.0000000 000000488 Fichez J, Mouillot T, Vonghia L, et al. Non-invasive tests for fibrotic MASH for reducing screen failure in therapeutic trials. JHEP Reports. 2025;7(4);101351. doi:10.1016/j.jhepr.2025.10135 Wattacheril JJ, Abdelmalek MF, Lim JK, et al. AGA clinical practice update on the role of noninvasive biomarkers in the evaluation and management of nonalcoholic fatty liver disease: expert review. Gastroenterology. 2023;165:1080-1088. doi:10.1053/j.ga stro.2023.06.013 Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, et al. AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023;77:1797-1835. doi:10.1097/HEP.0000000000000323 Newsome PN, Sanyal AJ, Engebretsen KA, et al. Semaglutide 2.4 mg in participants with metabolic dysfunction-associated steatohepatitis: baseline characteristics and design of the phase 3 ESSENCE trial. Aliment Pharmacol Ther. 2024;10:18331. doi:10.1111/apt.18331 Wegovy® (semaglutide) injection [package insert]. Plainsboro, NJ: Novo Nordisk Inc. Ilan Y. Analogy between non-alcoholic steatohepatitis (NASH) and hypertension: a stepwise patient-tailored approach for NASH treatment. Ann Gastroenterol. 2018; 31:296-304. doi:10.20524/aog.2018.0248 Tesfay M, Goldkamp JW, Neuschwander-Tetri BA. NASH: the emerging most common form of chronic liver disease. Mo Med. 2018;115:225-229. Quek J, Chan KE, Wong ZY, et al. Global prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis in the overweight and obese population: a systematic review and meta-analysis. Lancet Gastroenterol Hepatol. 2023;8:20-30. doi: 10.1016/S2468-1253(22)00317-X National Institute of Diabetes and Digestive and Kidney Diseases. Definition & facts of NAFLD & NASH. Accessed November 7, 2024. Available at: Allen AM, Charlton M, Cusi K, et al. Guideline-based management of metabolic dysfunction-associated steatotic liver disease in the primary care setting. Postgrad Med. 2024;136:229-245. doi:10.1080/00325481.2024.2325332 Sheka AC, Adeyi O, Thompson J, et al. Nonalcoholic steatohepatitis: a review. JAMA. 2020;323:1619. doi:10.1001/jama.2020.5249 Younossi ZM, Koenig AB, Abdelatif D, et al. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64(1):73-84. doi:10.1002/hep.28431 SOURCE NOVO NORDISK INC. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED