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Aleve® Demonstrates More Pain Relief Than a Commonly Prescribed Opioid After Wisdom Tooth Extraction, Studies Show

Bayer Consumer Health Announces Data From Two Single-Dose Studies at Annual ADA Meeting

WHIPPANY, N.J., Sept. 6, 2019 /PRNewswire/ -- Bayer today announced data that showed Aleve® (naproxen sodium) provided more pain relief from hour three onward than acetaminophen plus codeine after wisdom tooth removal. The results were presented at the American Dental Association (ADA) FDI World Dental Congress, taking place in San Francisco from September 4-8, 2019.

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. In the two single-dose studies, patients with moderate to severe pain following wisdom tooth extraction received either Aleve® 440 mg (two 220 mg capsules), acetaminophen plus codeine phosphate 660 mg/60 mg (two 300 mg/30 mg capsules), or a placebo and were asked to rate their pain levels over eight hours. From the three-hour mark onward in both studies, patients who took Aleve® reported significantly reduced pain compared to those taking acetaminophen plus codeine. The 12-hour strength of Aleve® also gave patients more sustained pain relief per dose, as demonstrated by a longer median time to re-medication, versus patients on acetaminophen plus codeine.

The findings have important implications for young people, as past ADA research1 shows the majority of U.S. patients undergoing wisdom tooth removal are younger than 25. In a study published in Pediatrics2, high school students who use prescribed opioids are 33 percent more likely to misuse opioids later in life, and according to Drug & Alcohol Dependence3, post-dental surgery prescriptions account for as many as 100 million unused opioid pills – which may later be misused by the patient or a friend or family member.

"Oral analgesics are widely used by doctors to manage acute dental pain, and dentists can select from a variety of over-the-counter and prescription options, including opioids, nonopioids and combinations. The choice of treatment should strike a balance between the drug's benefits and risks, optimizing efficacy while minimizing safety concerns," said Eishdeep Cattry, PharmD, Bayer Consumer Health, who presented the data. "The results of these studies suggest that nonopioid analgesics like naproxen sodium, found in Aleve®, may be a suitable alternative for dentists to recommend for minor pain following wisdom tooth surgery."

The randomized, double-blind, placebo- and active-controlled studies included a total of 455 patients who underwent surgical third molar extraction. The average age of patients was 24 in Study #1 and 21 in Study #2. In Study #1, 25 to 27 percent vs. 15 to 18 percent in Study 2 rated their postoperative dental pain at baseline as severe. Analgesic response by treatment was measured by the change in patients' total pain relief (TOTPAR) scores and the change in patients' sum of pain intensity differences (SPID). TOTPAR was calculated as the time-weighted sum of values based on the hourly change in pain-relief levels from baseline. Pain relief scores were derived from a five-point categorical scale (0=None, 1=A little, 2=Some, 3=A lot, 4=Complete); higher scores indicated greater pain relief. SPID was calculated as the time-weighted sum of values based on changes in pain-intensity levels from baseline to a given timepoint. Four-point Categorical Rating Scale (CRS) scores (0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain) were subtracted from baseline levels and converted into pain intensity difference (PID) scores; positive and higher PID scores indicated greater reduction in pain severity.

"Bayer is sharing this data with dentists and other dental professionals to increase their awareness of nonopioid options available that may effectively manage their patients' pain needs," said Manny Troullos, DMD, Senior Associate Director, Medical Affairs Analgesics, Bayer U.S. LLC. "These studies demonstrate that Aleve® is a safe and effective option for their patients to help with minor dental pain, and the studies reinforce Bayer's commitment to ensuring that patients and care providers have choices in managing pain."

More About the Studies

The primary efficacy endpoints were TOTPAR and SPID scores at 4 hours. Secondary efficacy endpoints included TOTPAR and SPID scores at 8 hours, peak PID, peak pain relief, time to relief onset, time to remedication, and overall medication rating for pain relief.

Topline Study #1 results (Aleve® compared to acetaminophen-codeine)

  • Mean 4-hour TOTPAR score: Aleve® 6.6, acetaminophen-codeine 5.1, placebo 1.3 (p<0.05, Aleve vs. AC and placebo).
  • Mean 8-hour TOTPAR score: Aleve® 11.5, acetaminophen-codeine 6.9, placebo 2.5 (p<0.05, Aleve vs. AC and placebo).
  • Mean 4-hour SPID score: Aleve® 2.6, acetaminophen-codeine 1.9, placebo -0.5 (p<0.05, Aleve vs. placebo).
  • Mean 8-hour SPID score: Aleve® 4.3, acetaminophen-codeine 2.1, placebo -1.0 (p<0.05, Aleve vs. AC and placebo).
  • Median time to remedication: Aleve® 5.9 hours, acetaminophen-codeine 3.4 hours, placebo 1.1 hours (p<0.05, Aleve vs. AC and placebo).

Topline Study #2 results (Aleve compared to acetaminophen-codeine) 

  • Mean 4-hour TOTPAR score: Aleve® 5.8, acetaminophen-codeine 5.4, placebo 1.6 (p<0.05, Aleve vs. placebo).
  • Mean 8-hour TOTPAR score: Aleve® 11.1, acetaminophen-codeine 8.1, placebo 2.5 (p<0.05, Aleve vs. AC and placebo).
  • Mean 4-hour SPID score: Aleve® 1.4, acetaminophen-codeine 1.7, placebo -1.4 (p<0.05, Aleve vs. placebo).
  • Mean 8-hour SPID score: Aleve® 2.8, acetaminophen-codeine 2.0, placebo -3.2 (p<0.05, Aleve vs. placebo).
  • Median time to remedication: Aleve® 6.5 hours, acetaminophen-codeine 3.7 hours, placebo 1.5 hours (p<0.05, Aleve vs. AC and placebo).

In both studies, fewer patients who took Aleve® experienced dizziness, sleepiness, nausea and vomiting than those on acetaminophen-codeine. The studies were sponsored by Bayer.

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 benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2018, the Group employed around 117,000 people and had sales of 39.6 billion euros. Capital expenditures amounted to 2.6 billion euros, R&D expenses to 5.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Media Contact:
Dan Childs
Phone: +1 973.437.0809
Email: daniel.childs@bayer.com


1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1963310/#r2 
2 https://pediatrics.aappublications.org/content/136/5/e1169 
3 https://www.sciencedirect.com/science/article/abs/pii/S0376871616302563

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