Monday, December 20, 2021

Bayer Consumer Health Division Announces Clinical Research Study Findings Evaluating Naproxen Sodium vs. an Opioid Combination in Acute Postsurgical Dental Pain

Study Shows a Single Dose of Over-The-Counter Naproxen Sodium (440 mg) is as Effective, Lasts Longer, and was Better Tolerated Than a Single Dose of a Commonly Prescribed Opioid

Bayer Consumer Health Division announced today its clinical research study, "Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial" was published online in the Postgraduate Medicine journal.

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

Overall, in a single dose study, NapS was as effective as HYD+APAP during hours 0-4, and longer lasting. NapS was found to meet the endpoints of reducing pain intensity over 12 hours (primary endpoint; p=0.01), total pain relief over 6 and 12 hours (p<0.05), time to rescue medication (p<0.001), and duration of pain at least half gone over 12 hours (p<0.001). The HYD+APAP treatment was not statistically superior to NapS for any endpoint. Additionally, more treatment-related adverse events were reported with HYD+APAP (n=63) than NapS (n=2) and placebo (n=20), including nausea, vomiting, and dizziness. Results showed NapS to be statistically superior to HYD+APAP for the primary and key secondary endpoints and to have a lower incidence of adverse events (14.4% vs. 39.1%).

"We set out to understand how NapS compares with a common opioid combination in dental pain. We were pleased that the results showed that NapS performed as well as it did in the study," said Charlene Ng, Interim Head of North America Medical Affairs, Bayer Consumer Health. "Knowing NSAIDs are commonly recommended as a first line of defense following dental procedures, we wanted to see how one dose of NapS directly compares to one dose of a commonly prescribed opioid combination. The study yielded positive findings that 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 Fast and effective management of acute pain is critical to minimize negative side-effects and current treatment guidelines worldwide recommend that first-line therapy in all mild-to-moderate pain conditions in adults should be oral non-steroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen (APAP). 3-5 Opioids, however, alone or in combination with other analgesics, continue to be prescribed for pain relief. Overprescribing opioids has led to unprecedented levels of relief which have the potential for addiction. 

The results of this single dose study demonstrate that NapS provides the same levels of pain relief from hours 0-4 as a commonly prescribed opioid combination 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 the United States2," said Dr. M. Ted Wong, DDS, MHA, oral healthcare and dental medical integration consultant. "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 key in the ongoing effort to mitigate the use of opioid combinations as a first line of defense for relieving minor pain after dental procedures. It is my hope that other dentists find the results as compelling as I do."

About the Study 
The study titled, "Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial," was a single center, randomized, double-blind, and placebo-controlled study in moderate or severe postoperative pain after the 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 a placebo within 4.5 hours post-surgery and were assessed over the course of 12 hours. The primary endpoint was the summed pain intensity difference from zero to 12 hours (SPID0-12) with secondary endpoints identified as pain intensity, pain relief, time to rescue medication (additional pain relief medication taken, if needed), and duration of pain at least half gone. Additional endpoints assessed include onset of pain relief, global assessment of treatment, and adverse events.

There were no serious adverse events (AEs) or treatment-emergent adverse events (TEAEs) that led 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% HYD+APAP patients and 13.6% of PBO patients. Results demonstrated that NapS was better tolerated than HYD+APAP with only one AE that was considered treatment related (somnolence) compared to 18 with HYD+APAP (mostly nausea, vomiting and dizziness) and compared to 1 with PBO (vomiting).

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4 billion euros. R&D expenses before special items amounted to 4.9 billion euros. For more information, go to

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