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%).
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.2
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.