Bayer’s Consumer Health Division Announces Results of a Clinical Research Study Evaluating Naproxen Sodium Versus a Combination Opioid in Post-Surgical Acute Dental Pain

WHIPPANY, NJ, December 17, 2021 /PRNewswire/ — Bayer Consumer Health Division today announced its clinical research study, “Analgesic Efficacy of Naproxen Sodium Compared with Hydrocodone/Acetaminophen in Acute Post-Surgical Dental Pain: A Randomized, Double-Blind, Placebo-Controlled Trial” was published online in the Postgraduate Medicine newspaper.

Aleve® is an over-the-counter pain reliever indicated for the temporary relief of minor pain, including minor arthritis pain, headaches, muscle aches and toothaches. The single dose study found that in the treatment of moderate to severe postsurgical dental pain, a single dose of non-prescription naproxen sodium 440mg (NapS) was at least as effective at 0-4 hours and better tolerated than a single dose of an opioid combination of hydrocodone plus acetaminophen 10/650 mg (HYD+APAP). This class of drugs is known to have the potential for abuse and addiction.1

Overall, in a single dose study, NapS was as effective as HYD + APAP for 0-4 hours, and longer lasting. NapS was found to meet the endpoints of reduction in pain intensity over 12 hours (primary endpoint; p=0.01), total pain relief over 6 and 12 hours (p

“We sought to understand how NapS compares to a common opioid combination in dental pain. We were pleased that the results showed that NapS worked as well as in the study,” said Charlene Ng, Acting Head of Medical Affairs for North America, Bayer Consumer Health. “Knowing that NSAIDs are generally recommended as the first line of defense after dental procedures, we wanted to see how a dose of NapS directly compares to a dose of a commonly prescribed opioid combination. The study showed positive results which can serve as valuable information for dental professionals when determining the appropriate treatment for their patients.

One of the most common reasons patients seek medical attention is for pain relief.2 Prompt and effective management of acute pain is essential to minimize negative side effects and current treatment guidelines worldwide recommend that first-line treatment for all mild to moderate pain conditions in adults be oral nonsteroidal anti-inflammatory drugs (NSAIDs). and/or acetaminophen (APAP). 3-5 However, opioids, alone or in combination with other pain relievers, continue to be prescribed for pain relief. The overprescription of opioids has led to unprecedented levels of relief that have the potential for addiction.2

The results of this single-dose study demonstrate that NapS provides the same levels of pain relief between hours 0 and 4 as a commonly prescribed combination of opioids for acute postoperative pain and can be considered by clinicians when recommending appropriate analgesics for minor pain.

“This study comes at a key time, as opioid addiction and overdose deaths have been declared a public health emergency in United States2“said Dr M. Ted Wang, DDS, MHA, consultant in oral and dental integration. “In reviewing the results, the study shows that NapS may be an effective, non-addictive treatment option for those undergoing dental procedures. Data like this is critical in the ongoing effort to mitigate the use of combinations of opioids as the first line of defense for minor pain relief after dental procedures. I hope other dentists will find the results as compelling as I have.

About the study
The study titled “Analgesic Efficacy of Naproxen Sodium Compared with Hydrocodone/Acetaminophen in Acute Post-Surgical Dental Pain: A Randomized, Double-Blind, Placebo-Controlled Trial”, was a single-center, randomized, double-blind study and placebo-controlled in moderate or severe postoperative pain after surgical removal of impacted third molars. Patients (n=212) received either a single dose of NapS (Aleve®, Bayer Bitterfeld, Germany; 220 mg x two tablets), HYD+APAP (Norco®, Amneal Pharmaceuticals, NY, USA; 5+325 mg x two tablets), or placebo within 4.5 hours of surgery and were evaluated on a 12 hour period. The primary endpoint was the sum of pain intensity differences from zero to 12 hours (SPID0-12) with secondary endpoints identified as pain intensity, pain relief, time to medication relief (additional pain medications taken, if needed), and duration of pain at least half gone . Additional parameters assessed include onset of pain relief, global treatment assessment, and adverse events.

There were no serious adverse events (AEs) or treatment-related adverse events (TEAEs) leading to study discontinuation. A total of 85 TEAEs were reported (NapS, n=2; HYD+APAP, n=63; PBO, n=20). Most AEs were classified as mild, but moderate in 21.8% of HYD+APAP patients and 13.6% of PBO patients. The results demonstrated that NapS was better tolerated than HYD+APAP with only one AE considered to be related to the treatment (drowsiness) against 18 with HYD+APAP (mainly nausea, vomiting and dizziness) and against 1 with PBO (vomiting).

About Bayer
Bayer is a global company with core competencies in the areas of life sciences healthcare and nutrition. Its products and services are designed to help people and the planet prosper by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to fostering sustainable development and generating a positive impact on its activities. At the same time, the Group aims to increase its profitability and create value through innovation and growth. The Bayer brand is synonymous with trust, reliability and quality around the world. In fiscal year 2020, the Group employed approximately 100,000 people and generated revenue of €41.4 billion. R&D expenses before exceptional items amounted to 4.9 billion euros. For more information, visit www.bayer.com.

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Keri Madone
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1 American Dental Association. ADA Dental Drug Handbook: A Quick Reference. Chicago, IL: American Dental Association; 2019.
2 Kuehn B. Declared opioid emergency. JAMA. 2017;318:2418-2418. doi: 10.1001/jama.2017.19014.
3 Morlion B, Coluzzi F, Aldington D, et al. Chronification of pain: what should a non-specialist in pain medicine know? Running. Med. Res. Opinion. 2018;34:1169-1178. doi: 10.1080/03007995.2018.1449738.
4 Sinatra R. Causes and consequences of inadequate management of acute pain. Med pain. 2010;11:1859-1871. doi: 10.1111/j.1526-4637.2010.00983.x.
5 Hagen M, Alchin J. Over-the-counter medications recommended in guidelines for common painful conditions. Pain management. 2019;10:117-129. doi: 10.2217/pmt-2019-0057.

SOURCE Bayer Consumer Health Division

Paul N. Strickland