Hydrocodone bitartrate

TYLENOL® with Naproxen, a first-of-its-kind, non-opioid OTC option for the millions managing persistent pain, is backed by more than a decade of research, including Phase 3 data to be presented at PAINWeek In two rigorous Phase 3 clinical studies, findings demonstrated the effectiveness of TYLENOL® with Naproxen in both post-surgical dental pain and bunionectomy pain, which raises the bar on clinically proven effectiveness for OTC combination products. PAINWeek will also showcase Phase 2 proof-of-concept findings, demonstrating that TYLENOL® with Naproxen has superior efficacy to a prescription hydrocodone (opioid) combination. Study results support the recent FDA approval of the first and only over-the-counter (OTC) combination of acetaminophen (650 mg) and naproxen sodium (220 mg) in a single product, filling a longstanding need for a simple option that quickly delivers potent, long-lasting pain relief. SUMMIT, N.J., Sept. 8, 2026 /PRNewswire/ -- TYLENOL®, the #1 doctor-recommended pain relief brand, will present compelling research data supporting the clinical efficacy of TYLENOL® with Naproxen at the 20th Annual PAINWeek Conference in Las Vegas, September 8-11, 2026. The findings, drawn from two pivotal Phase 3 studies in post-surgical dental pain and bunionectomy pain, reflect more than a decade of rigorous clinical development behind TYLENOL® with Naproxen, a new, non-opioid, OTC combination pain relief medicine approved by the U.S. Food and Drug Administration (FDA) in July 2026. Continue Reading TYLENOL® with Naproxen is the first and only FDA-approved over-the-counter pain reliever that combines 650 mg of acetaminophen and 220 mg of naproxen sodium in a single fixed-dose, and will be coming soon to major U.S. retailers nationwide. TYLENOL® with Naproxen combines the fast-acting relief of 650 mg of acetaminophen with the long-lasting analgesic power of 220 mg of naproxen sodium (a non-steroidal anti-inflammatory drug) in a single dose that begins working in under 30 minutes and provides relief for 12 hours. "For millions of people managing persistent pain, treatment often means choosing between short-term relief and more complex pain management options. As healthcare professionals and consumers continue to seek effective non-opioid alternatives to treat pain, TYLENOL® with Naproxen offers an evidence-backed option that combines two trusted ingredients in a single fast-acting, potent product, providing a simple approach for clinicians to recommend and patients to use," said Dr. Rajesh Mishra, MD, PhD, Chief Medical Officer, Kenvue. Phase 3 Studies Demonstrate Superior Performance Across Two Rigorous Pain Clinical Models The new data evaluated TYLENOL® with Naproxen in two rigorously studied models that have been shown to reflect the type of pain experienced in many common, real-world acute pain conditions. In a Phase 3 placebo-controlled, randomized, double-blind, factorial clinical study in patients with moderate-to-severe post-operative dental pain, the fixed-dose combination outperformed both acetaminophen alone and naproxen sodium alone (Aleve1 220 mg) over a 12-hour period.2 It also delivered meaningful pain relief faster than naproxen sodium and lasted longer than acetaminophen.2 Separately, in a Phase 3 multiple-dose, placebo-controlled, randomized, double-blind clinical study in post-surgical bunionectomy pain, TYLENOL® with Naproxen delivered significant and sustained pain relief as compared to placebo.3 This is the first clinical study of an OTC-intended pain medicine in the bunionectomy model, a rigorous benchmark often used to evaluate prescription pain therapies. In this study, TYLENOL® with Naproxen reduced the total amount of opioid rescue medication used over 48 hours by nearly 40%, compared with placebo.3 Together, these studies demonstrate consistent effectiveness across distinct pain settings, from dental pain to post-surgical bunionectomy pain. These findings build on earlier research from a previously reported Phase 2 clinical study in post-operative dental pain, in which TYLENOL® dosed alongside naproxen sodium provided more effective and longer-lasting pain relief than a hydrocodone and acetaminophen combination.4 "Across these clinical studies, the fixed-dose combination consistently provided 12 hours of potent pain relief, in two distinct and well-validated pain models. Evaluating an over-the-counter option in post-surgical settings sets a high evidentiary bar for analgesic effectiveness, and these results give clinicians and patients meaningful data to inform pain management decisions," said Todd Bertoch, MD, Chief Medical Officer, Pain Research at CenExel Clinical Research, Inc., and a principal investigator on the TYLENOL® with Naproxen clinical program. The PAINWeek presentations share the pivotal data from a clinical program composed of eight studies spanning more than a decade, making TYLENOL® with Naproxen one of the most extensively studied OTC pain innovations introduced in the past decade. Additional analyses and results from the clinical program will be presented at additional upcoming medical meetings in 2026. TYLENOL® with Naproxen will be coming soon to major U.S. retailers nationwide. To learn more, visit or follow TYLENOL® on Instagram and TikTok. About TYLENOL® with Naproxen and PAINWeek How many studies and posters are being presented at PAINWeek? TYLENOL® with Naproxen is featured across four scientific posters – the data from the pivotal Phase 3 dental pain trial will be presented for the first time and compared to the previous Phase 2 proof-of-concept dental pain trial. Data from a second pivotal Phase 3 bunionectomy trial will also be presented for the first time. In addition, there will be posters on the pharmacokinetic/mechanistic rationale and a national pharmacist practice survey – as well as a breakfast symposium, expert roundtable and interactive booth. Is this the evidence that supported the July 2026 approval? Yes, the evidence being presented at PAINWeek is part of the 8 clinical studies that supported the FDA approval for TYLENOL® with Naproxen. Additional analyses and study results will be presented at other medical meetings later this year. Which pain types were evaluated in these studies? Post-operative dental pain and post-surgical pain after a bunionectomy were evaluated in these studies. What is TYLENOL® with Naproxen? TYLENOL® with Naproxen is the first and only FDA-approved over-the-counter pain reliever that combines 650 mg of acetaminophen and 220 mg of naproxen sodium in a single fixed-dose. It is indicated for the temporary relief of minor aches and pain in adults and children 12 years and over and is available without a prescription. For children under 12, consult a healthcare provider. How is it different from regular TYLENOL® or Aleve? Single-ingredient TYLENOL® contains acetaminophen only. Aleve contains naproxen sodium only. TYLENOL® with Naproxen combines the fast-acting relief of acetaminophen with the long-lasting power of a non-steroidal anti-inflammatory drug, naproxen sodium – starting to work in under 30 minutes and delivering effective pain relief for 12 hours. By combining two well-established pain medicines that work through different mechanisms, TYLENOL® with Naproxen was designed to provide powerful pain relief while using lower doses of each ingredient.  How does TYLENOL® with Naproxen work? Acetaminophen is believed to work quickly to reduce pain signals. Naproxen sodium, a non-steroidal anti-inflammatory drug (NSAID), provides longer-lasting relief by targeting pain caused by inflammation. Combining them in a single dose delivers both fast onset and extended duration of pain relief. Is TYLENOL® with Naproxen an opioid? No. TYLENOL® with Naproxen is opioid-free. It is intended to expand non-opioid pain management options for patients and healthcare providers. When and where will TYLENOL® with Naproxen be available? TYLENOL® with Naproxen will be coming soon to major U.S. retailers nationwide. To learn more, visit or follow TYLENOL® on Instagram and TikTok. How can consumers determine if TYLENOL® with Naproxen is right for them? Consumers should always read and follow the Drug Facts label and talk with a healthcare professional if they have questions about whether TYLENOL® with Naproxen is right for them. About TYLENOL® TYLENOL® – the #1 doctor-recommended brand of pain and fever relief – offers a growing portfolio of products designed to help people manage their health. From trusted OTC medicines to innovative topicals, TYLENOL® is committed to providing Care Without Limits™ by addressing a wide range of needs across ages and through every stage of life. TYLENOL® is a brand of Kenvue Brands LLC, a subsidiary of Kenvue Inc. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the development of TYLENOL® with Naproxen. Forward-looking statements may be identified by the use of words such as "plans," "expects," "will," "anticipates," "estimates" and other words of similar meaning. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kenvue Inc. and its affiliates. A list and descriptions of risks, uncertainties and other factors can be found in Kenvue's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 28, 2025 and subsequent Quarterly Reports on Form 10-Q and other filings, available at or on request from Kenvue. Kenvue and its affiliates undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or developments or otherwise. Media Contact: Sam Higgins ([email protected]) 1 Aleve is a trademark of Bayer Healthcare LLC 2 Budnitz D, et al. Analgesic Effectiveness of a New Fixed-Dose Combination Acetaminophen/Naproxen Sodium: A Phase 3 Placebo-controlled, Randomized, Double-blind, Factorial Trial in Post-operative Dental Pain. PAINWeek 2026, Las Vegas, NV. Poster P083. 3 Tharakan M, et al. A Phase 3 Multiple-dose Efficacy and Safety Trial of a Novel Fixed Dose Combination of Acetaminophen and Naproxen Sodium in a Post-surgical Bunionectomy Pain Model. PAINWeek 2026, Las Vegas, NV. Poster P081. 4 Sacavage S, Myers A, McGuire JA, Pinto C, Cooper SA, Bertoch T. Proof of Concept Study Evaluating the Relative Efficacy and Safety of Concomitant Acetaminophen-Naproxen Sodium versus Acetaminophen/Hydrocodone and Naproxen Sodium in Postoperative Dental Pain. PAINWeek 2021. 7-11 Sep 2021, Las Vegas, NV. Poster P090. SOURCE Kenvue Inc. 21% more press release views with Request a Demo

本文要点 研究背景与设计 基于美国医保索赔数据开展真实世界新使用者队列研究，纳入411188名使用GLP-1受体激动剂（GLP-1RA）的2型糖尿病成年人，比较启动羟考酮、氢可酮或曲马多后30天胃肠动力相关事件风险。 核心发现与意义 羟考酮启动与更高的短期重度便秘和肠梗阻风险相关，为GLP-1受体激动剂使用者的阿片选择提供安全性参考，但观察性关联不等同于因果关系。 三种阿片的风险梯度 加权30天复合事件绝对风险分别为羟考酮0.51%、氢可酮0.35%和曲马多0.33%。羟考酮相较氢可酮和曲马多的相对风险分别为1.48和1.55，风险差分别为0.17和0.18个百分点。 风险差异的主要事件 组间风险差异主要由重度便秘和肠梗阻驱动。 胃轻瘫结果 三组胃轻瘫事件均少，未观察到显著差异，但相关估计值较不精确。 敏感性分析结果 羟考酮风险升高的关联在多项敏感性分析中保持一致。氢可酮与曲马多在主要分析中的风险相近，但部分次要分析结果出现波动，高龄或衰弱患者的绝对风险更高。 核心关键词 GLP-1受体激动剂　　2型糖尿病　　阿片类药物　　羟考酮　　胃肠动力事件　　重度便秘　　肠梗阻 科普解读 对于数百万同时使用 GLP-1受体激动剂（GLP-1RA）和阿片类药物 的2型糖尿病患者而言，一个长期被忽视的临床难题正浮出水面：这两种药物都会减缓胃肠运动，当它们“联手”时，谁的肠道风险更高？一项发表于Diabetes Care的最新研究，首次通过对超过41万人的真实世界数据分析，给出了明确的答案。 这项研究由来自布莱根妇女医院的Sungho Bea团队主导，系统比较了在已使用GLP-1RA的患者中，新启用三种常用阿片类药物—— 羟考酮 、 氢可酮 和 曲马多 ——的短期胃肠道安全性。研究团队利用美国三个大型医保数据库，构建了一个 新用药者队列 ，试图填补这一关键的知识空白。 一场肠道里的“双重减速”危机 GLP-1RA早已成为2型糖尿病治疗的基石，其通过延缓胃排空来发挥降糖和减重作用。然而，这种机制也带来了恶心、便秘乃至 肠梗阻 等不良反应。阿片类药物则通过激活肠道神经系统的μ-阿片受体，同样会抑制胃肠蠕动。当患者因疼痛需要服用阿片类药物时，两种药物的作用叠加，构成了一个潜在的 安全雷区 。 研究团队正是聚焦于这一高风险场景。他们从数据库中筛选出在2016年至2025年间，正在接受GLP-1RA治疗、且首次启用阿片类药物的成年2型糖尿病患者。最终纳入的411,188名患者，平均年龄为62.8岁，其中 53.8%为女性 。他们被分为三组：24.4%启用了羟考酮，48.5%启用了氢可酮，27.1%启用了曲马多。 30天内的风险赛跑：羟考酮显著领先 为了确保公平比较，研究者运用了 倾向性评分匹配加权 的方法，平衡了三组患者在年龄、疼痛状况、合并症等方面的差异。随后，他们紧盯患者用药后的 30天窗口期 ，观察一个复合终点——包括严重便秘、肠梗阻和胃轻瘫在内的运动相关胃肠道事件的发生率。 数据清晰地揭示了风险分层。加权后，羟考酮组的30天绝对风险最高，为0.51%；氢可酮组为0.35%；曲马多组最低，为0.33%。与曲马多相比，羟考酮使风险升高了 55% （风险比RR=1.55），与氢可酮相比，风险也升高了 48% （RR=1.48）。换算成绝对风险差，意味着每治疗约588人，羟考酮就会比氢可酮多导致一例严重胃肠道事件。 值得注意的是，这种风险的增高主要由 严重便秘 和 肠梗阻 驱动。在次要分析中，羟考酮与这两种结局的风险比均显著升高，而氢可酮与曲马多之间则未观察到显著差异。至于胃轻瘫，三组的发生率都极低，且风险相当，未显示出统计学差异。 风险背后的微妙差异与脆弱人群 尽管氢可酮和曲马多在主分析中风险相似，但在排除了急性疼痛患者的亚组分析中，氢可酮的风险反而低于曲马多。这提示， 疼痛类型和潜在适应症 可能对结果存在混杂影响，临床解读需保持谨慎。 研究团队推测，药理学差异可能部分解释这些发现。曲马多是一种 弱μ-受体激动剂 ，其镇痛作用有相当部分来自对5-羟色胺和去甲肾上腺素再摄取的抑制，这可能通过肠道5-羟色胺受体，减弱了对胃肠蠕动的直接抑制。相比之下，羟考酮和氢可酮作为 完全的μ-受体激动剂 ，对肠道蠕动的抑制更为直接和强烈。但氢可酮与曲马多风险的相似性也表明，影响机制是 多因素的 ，不能仅归因于受体亲和力。 此外，研究还揭示了两个高危群体： 老年患者 和 虚弱个体 。无论使用哪种阿片类药物，他们发生胃肠道事件的绝对风险都更高。例如，在虚弱患者中，羟考酮组的30天风险高达 1.19% ，凸显了在处方时需要格外审慎。 对临床实践的审慎启示 这项研究并非没有局限。它基于医保赔付数据，无法完全排除疼痛严重程度、生活方式等未测量因素的混杂影响。大部分患者的阿片类药物使用均为短期，仅一次处方后即停药，因此研究结论主要适用于 短期用药风险 ，无法外推至慢性长期使用。此外，所观察到的绝对风险差异虽然具有统计学显著性，但在个体层面仍属较小。 然而，考虑到GLP-1RA和阿片类药物的广泛使用，即便是微小的绝对风险差异，在人群层面也可能产生 不可忽视的临床影响 。该研究为临床医生的决策工具箱增添了一份关键证据：在为使用GLP-1RA的患者开具止痛药时，选择羟考酮可能意味着更高的短期肠道风险，而氢可酮或曲马多或许是更安全的选择。这一发现，为在“镇痛”与“肠道安全”之间寻求精妙平衡，提供了及时且重要的科学指引。 图片摘要 相关文章推荐 01 New England Journal of Medicine · IF: 84.5 NEJM：一月一针！新型减肥药不仅减重16%，还能改善血糖 02 JAMA Internal Medicine · IF: 26.3 JAMA子刊：使用GLP-1类减肥药物，患者需要了解什么？ 03 Annals of Internal Medicine · IF: 17.2 2型糖尿病患者使用GLP-1药物，需注意胃食管反流副作用 04 British Medical Journal · IF: 55.1 BMJ：2型糖尿病药物全景图！如何平衡益处与副作用？ 05 Clinical Gastroenterology and Hepatology · IF: 16.2 GLP-1药物可降低消化性溃疡风险 原文链接 https://rbase.chinagut.cn/base/article/899310b322e64e16955bf06c52d0823a