STUDY RESULTS
Aleve® was as effective* as HYD+APAP at hours 0 to 4 at reducing pain intensity.†
The primary endpoint was met
Sum of Pain Intensity Difference from 0 to 12 hours (SPID0-12) was statistically significant for Aleve® vs HYD+APAP.
Key secondary endpoints also showed statistical significance compared with HYD+APAP:
- Total pain relief (0 to 6 and 0 to 12 hours; P<0.05)
- Median time to rescue medication (P<0.001)
- Duration of pain at least half gone over 12 hours (P<0.001)
Both active treatments were significantly more effective than placebo
HYD+APAP was not statistically superior to Aleve® for any endpoint.
*In hours 0 to 4 of a single-dose dental study of Aleve® (440 mg), HYD+APAP (10 mg + 650 mg), or placebo.1
†Based on SPID0-4.1
OA, osteoarthritis.
References: 1. Cooper SA, Desjardins PJ, Bertoch T, et al. Analgesic efficacy of naproxen sodium versus hydrocodone/acetaminophen in acute postsurgical dental pain: a randomized, double-blind, placebo-controlled trial. Postgrad Med. 2021. doi:10.1080/00325481.2021.2008180 2. Data on file. Bayer Consumer Health.