- 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., 8 de setembro de 2026 — 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, 8 a 11 de setembro, 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 julho de 2026.
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 (Aleve[1] 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.
O Tylenol® com naproxeno chegará em breve aos principais varejistas dos EUA em todo o país. To learn more, visit www.tylenol.com 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 julho de 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.
O que é Tylenol® com naproxeno?
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.
Qual é a diferença entre Tylenol® padrão ou Aleve?
O Tylenol® de ingrediente único contém apenas acetaminofeno. O Aleve contém apenas naproxeno sódico. O Tylenol® com naproxeno combina o alívio de ação rápida do acetaminofeno com o poder duradouro de um medicamento anti-inflamatório não esteroide, o naproxeno sódico , começando a funcionar em menos de 30 minutos e proporcionando alívio eficaz da dor por 12 horas. 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.
Como funciona o Tylenol® com naproxeno?
Acredita-se que o acetaminofeno funcione rapidamente para reduzir os sinais de dor. O naproxeno sódico, um medicamento anti-inflamatório não esteroide (AINE), proporciona alívio mais duradouro, visando a dor causada pela inflamação. Combiná-los em uma única dose proporciona início rápido e duração prolongada do alívio da dor.
Tylenol® com naproxeno é um opioide?
Não. Tylenol® com naproxeno não contém opioide. Ele tem como objetivo expandir as opções de controle da dor não opioide para pacientes e profissionais de saúde.
Quando e onde o Tylenol® com naproxeno estará disponível?
O Tylenol® com naproxeno chegará em breve aos principais varejistas dos EUA em todo o país. To learn more, visit www.tylenol.com or follow TYLENOL® on Instagram and TikTok.
How can consumers determine if TYLENOL® with Naproxen is right for them?
Os consumidores devem sempre ler e seguir o rótulo de Fatos sobre o medicamento e conversar com um profissional da saúde se tiverem dúvidas sobre se o Tylenol® com naproxeno é adequado para eles.
About TYLENOL®
Tylenol®, a marca de alívio da dor e da febre recomendada pelos médicos, oferece um portfólio crescente de produtos projetados para ajudar as pessoas a gerenciarem sua saúde. De medicamentos de confiança sem prescrição médica a produtos tópicos inovadores e suplementos, Tylenol® tem o compromisso de fornecer cuidados sem limites, abordando uma ampla gama de necessidades em todas as idades e em todas as fases da vida. Tylenol® é uma marca da Kenvue Brands LLC, uma subsidiária da Kenvue Inc.
Advertências referentes às declarações prospectivas
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. Declarações prospectivas podem ser identificadas pelo uso de palavras como “planeja”, “espera”, “vai”, “prevê”, “estima” e outras palavras de significado semelhante. Aconselha-se que o leitor não confie nessas declarações prospectivas. Essas declarações são baseadas em expectativas atuais de eventos futuros. Se pressupostos subjacentes se provarem imprecisos, ou se riscos conhecidos ou desconhecidos ou incertezas se materializarem, os resultados reais poderão variar materialmente das expectativas e projeções da Kenvue Inc. e suas afiliadas.
Uma lista e descrições de riscos, incertezas e outros fatores podem ser encontradas nos registros da Kenvue com a Comissão de Valores Mobiliários dos Estados Unidos, incluindo seu Relatório Anual no Formulário 10-K para o ano fiscal terminado em 28 de dezembro de 2025, e Relatórios Trimestrais subsequentes no Formulário 10-Q e outros registros, disponíveis em www.kenvue.com ou mediante solicitação à Kenvue. A Kenvue e seus afiliados renunciam a qualquer obrigação de atualizar qualquer declaração prospectiva como resultado de novas informações, eventos ou desenvolvimentos futuros ou outros.
Contato de imprensa: Sam Higgins (media@kenvue.com)
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 20 de setembro21, Las Vegas, NV. Poster P090.