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.