NEW YORK — The National Advertising Review Board on Tuesday recommended that Novartis Consumer Health discontinue advertising claims that the company’s Excedrin Extra Strength product starts relieving headache pain faster than Advil.
The claims at issue were initially challenged before the National Advertising Division of the Council of Better Business Bureaus by Pfizer Consumer Healthcare, makers of Advil.
NAD determined that Novartis did not provide a reasonable basis to support those claims, the review organization stated. NARB noted in its decision that when efficacy claims are made for pain-relief medication, “those claims must be supported by at least one adequate and well-controlled scientific study that measures efficacy in treating the type of pain for which efficacy is claimed — e.g., substantiation for claims involving relief of tension headache pain should include at least one scientific study that evaluates efficacy in treating tension headache pain.”
In this case, Novartis offered as support for its claims studies related to migraine and dental pain, as well as one study — the “201 study," which evaluated speed of relief in treating tension headaches.
The panel noted that the "201 study" focused on the following “four analgesic variables” during the first hour after ingestion of the test medication:
Time to at least half relieved pain;
Time to complete pain relief;
Weighted sum of pain intensity difference scores; and
Time to meaningful pain relief.
The study found no statistically significant differences between subjects who received Excedrin and subjects who received Advil with respect to the first three variables. While a statistically significant difference of 5.1 minutes was arguably found in looking at median time to achieve meaningful pain relief within the first hour, no statistically significant differences were found at any of the 10-minute measurements except for the 40-minute measurement, NARB noted.
Novartis, in its advertiser’s statement, stated the company “disagrees with the NAD and NARB conclusions regarding the scientific substantiation in issue but will comply with the recommendations made."