HEALTH

NARB upholds Advil’s challenge of Excedrin’s faster-relief claims

BY Michael Johnsen

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."


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HEALTH

Help Remedies introduces guaifenesin SKU

BY Michael Johnsen

NEW YORK — Help Remedies last week launched a new product targeted toward those suffering from chest congestion. The new expectorant, branded "Help I have chest congestion," contains the single active ingredient guaifenesin (200 mg), and is now available nationally at Target, the company stated.

"Help I have chest congestion" becomes the eighth in Help’s line of over-the-counter healthcare products, nationally distributed through retailers, including Target, Walgreens, Duane Reade, Pharmaca, 3floz.com, regional supermarkets and boutique hotels. Each pack of "Help I have chest congestion" contains 16 tablets and has a suggested retail price of $3.99.


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McNeil Consumer to make marketing splash as OTC brands return to market

BY Michael Johnsen

NEW BRUNSWICK, N.J. — Johnson & Johnson is preparing to turn the corner with its McNeil Consumer Healthcare business, J&J chairman and CEO William Weldon told analysts during the company’s fourth-quarter earnings call Tuesday. That over-the-counter business generated $5.2 billion in the United States for the year ended Jan. 2, representing a 6.7% decline as compared to 2010.

"A big part of our consumer story in 2011 and going into 2012 has been the recovery and remediation of McNeil Consumer Healthcare business," Weldon said. "We’ve achieved all major commitments to date under our consent decree with the [Food and Drug Administration] and are working closely with FDA officials to ensure we can get high-quality products back to our loyal customers who need them." Several key products already have returned to the market, Weldon said, including Tylenol Severe Cold caplets and certain children’s and infants’ Tylenol brands. In addition, McNeil introduced a flow-restrictor packaging across its children’s medicines to help reduce dosing errors. "We will continue to invest in market support as we deliver a steady supply of our OTC brands back into the market."

Weldon noted, however, that reclaiming lost marketshare across its OTC franchises will be an uphill battle. "It will be a while until we reclaim the share," he said. "What we’re doing is getting them out as quickly as we can and what we’re getting in the market is selling. I think by the middle of 2012, we’ll have most of the products that are going to put back in the market — definitely by the end of 2012."

Johnson and Johnson anticipates re-opening its closed Fort Washington, Pa., manufacturing facility in 2013. 

Worldwide, Weldon noted that J&J is still the sixth largest consumer healthcare company, with $14.9 billion in total sales, up 2% overall. "For [our consumer segment], we saw an operational sales decline of just under 1%, given the remediation and supply issues associated with our U.S. OTC business," Weldon said. "Our consumer business saw solid growth in certain franchises like skin care and oral care, with strong performances from the Neutrogena and Listerine mouthwash brands. … We also continued to innovate, introducing Neutrogena Naturals, Aveeno Smart Essentials, Nicorette Quick Mist and Listerine Zero." The Nicorette Quick Mist is a smoking-cessation mouthspray launched last year in the United Kingdom — GlaxoSmithKline holds the license on the Nicorette brand in the United States — that is marketed as a "fast-acting, flexible and designed for life on-the-go" smoking-cessation solution. 


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