FDA approves first-of-its-kind pain medication for long-lasting relief

The Food and Drug Administration has granted approval for a new over-the-counter pain relief medication. This product marks a change in treatment options by combining acetaminophen and naproxen sodium into a single tablet. The formulation aims to address the needs of patients who report dissatisfaction with current pain management choices.

Kenvue, the manufacturer based in Summit, New Jersey, developed the medication to provide a balance of rapid response and extended duration. Each tablet contains 325 mg of acetaminophen and 110 mg of naproxen sodium. Patients take two tablets per dose for a total of 650 mg and 220 mg respectively. The drug is intended for adults and children age 12 and older.

Clinical data from the manufacturer indicates the medication begins working in under 30 minutes. The combination is designed to offer relief for up to 12 hours. Kenvue cites a internal survey of over 6,000 people which found that 75 percent of those dealing with persistent pain were not satisfied with available non-prescription options.

This is the first time these two specific active ingredients have been paired in an over-the-counter product. The FDA has awarded the company a three-year period of market exclusivity for this formulation. The medication offers a non-opioid alternative for those treating minor aches, muscle soreness, and backaches.