New York, NY – Sept. 10, 2019 – Following a challenge by Bayer Healthcare, LLC, the National Advertising Division recommended that Pfizer Consumer Healthcare discontinue challenged durational parity claims that “Nothing’s been proven to last longer than Advil” and “Nothing works . . . longer than Advil,” for its Advil over-the-counter pain medication.

NAD is an investigative unit of the advertising industry’s system of self-regulation and is a division of the BBB NP’s self-regulatory and dispute resolution programs.

Both parties in this challenge market competing over-the-counter pain medications.  Pfizer’s Advil product uses the active ingredient ibuprofen and has been available OTC since 1984. Bayer’s Aleve, containing the active ingredient naproxen sodium, had been available as a prescription medication prior to being approved as an OTC pain reliever in 1994. The claim at issue, “Nothing works longer than Advil,” has been in the marketplace since 2007.

In support of its claims, Pfizer provided three studies from 1993 comparing the duration of analgesia of naproxen sodium to that of ibuprofen, that found no statistically significant differences in how long the two drugs provide pain relief.  These three studies were conducted by the prior maker of Aleve and served as support for Aleve’s FDA approval as an OTC medication. 

However, Bayer, the current maker of Aleve, argued that its 2018 study comparing the duration of the two products’ pain relief efficacy, demonstrates that Pfizer’s durational parity claim is not substantiated.  Bayer contended that its study is better evidence than the older studies submitted by Pfizer and shows that, in fact, Aleve is longer lasting than Advil.

NAD carefully assessed the reliability of the study evidence submitted by both parties regarding the relative duration of analgesia.  While NAD determined that the studies submitted by Pfizer served as a reasonable basis for its claims, NAD noted that the progress of scientific study necessitates review of new evidence to determine whether it represents an improved understanding of the underlying truth of a given claim.  To that end, NAD considered whether Bayer’s 2018 study constitutes more persuasive evidence regarding the relative duration of the two drugs than Pfizer’s studies.

NAD noted that all of the studies in the record used a third-molar (“wisdom tooth”) extraction model of dental pain and were randomized, double-blind and placebo-controlled. The primary metric for duration of effectiveness cited by both parties was “median time to rescue,” that is, the median time from the administration of a single dose of a medication until subjects’ pain returned to a level where they request additional medication. NAD also considered each of the key differences between the older studies cited by Pfizer and the 2018 study conducted by Bayer, including inpatient vs. outpatient, study length, and pain level represented in the study.

NAD concluded that, for the limited purpose of rebutting the comparative claim that “Nothing lasts longer than Advil,” the 2018 study was persuasive evidence and reflected actual differences in the duration of analgesia between the two medications. Therefore, NAD found that Pfizer’s claims that “Nothing’s been proven to last longer than Advil” and “Nothing works . . . longer than Advil” are not supported by the totality of the evidence in the record and recommended that the claims be discontinued. In its advertiser’s statement, Pfizer stated that it “agrees to comply with NAD’s recommendation to discontinue the durational parity claim at issue.”