TYLENOL® with Naproxen Presents Efficacy Data at PAINWeek 2026

At PAINWeek 2026, TYLENOL® with Naproxen will present compelling research supporting its efficacy as a first-of-its-kind, non-opioid over-the-counter (OTC) option for managing persistent pain. This new product, approved by the U.S. Food and Drug Administration (FDA) in July 2026, combines 650 mg of acetaminophen with 220 mg of naproxen sodium in a single, fast-acting, potent dose.

The approval of TYLENOL® with Naproxen marks a significant step in non-opioid pain management, addressing a longstanding need for a simple yet effective solution. The product's development is backed by more than a decade of rigorous clinical research, including two pivotal Phase 3 clinical studies that evaluated its performance in post-surgical dental pain and bunionectomy pain.

In the first study, TYLENOL® with Naproxen demonstrated superior efficacy compared to acetaminophen alone and naproxen sodium alone. The fixed-dose combination provided faster and more sustained pain relief, with significant pain reduction lasting up to 12 hours. Additionally, the study showed that TYLENOL® with Naproxen outperformed a prescription hydrocodone combination in a Phase 2 proof-of-concept study, further highlighting its potential as an effective non-opioid alternative.

The second Phase 3 study focused on post-surgical bunionectomy pain. Patients who used TYLENOL® with Naproxen experienced 39% less use of opioid rescue medication over 48 hours compared to those who received a placebo. This outcome underscores the product's ability to deliver long-lasting pain relief in a real-world surgical setting.

Dr. Rajesh Mishra, Chief Medical Officer at Kenvue, emphasized the significance of TYLENOL® with Naproxen for pain management. "For millions of people managing persistent pain, treatment often means choosing between short-term relief and more complex pain management options. 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."

The PAINWeek presentations will share the pivotal data from eight studies spanning over a decade, making TYLENOL® with Naproxen one of the most extensively studied OTC pain innovations in recent years. Additional analyses and results will be presented at other medical meetings in 2026, further solidifying its position as a leading non-opioid pain management option.

Tylenol with Naproxen will be available soon in major U.S. retailers. Interested consumers can learn more at www.tylenol.com.