NAD Finds Westport Can Support Claims for ZEPHREX-D Following Challenge by Acura Pharmaceuticals

New York, NY – June 12, 2014 – The National Advertising Division has determined that Westport Pharmaceuticals, LLC, maker of ZEPHREX-D nasal decongestant tablets, can support the claims challenged before NAD by Acura Pharmaceuticals, Inc., the maker of NEXAFED, a competing product.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

Acura challenged advertising claims that appeared in broadcast, print and Internet advertising, including:

  •  “Fast, effective relief.”
  •  “Fast acting, going to work in as little as 30 minutes.”
  •  “Starts working to clear swollen passages in as little as 30 minutes.”
  •  “Maintains full efficacy providing necessary clinical benefits for patients.”

According to the challenger, the pseudoephedrine in traditional decongestants often provides the chemical precursor to methamphetamine production. Both NEXAFED and ZEPHREX-D are specially formulated to resist extraction and conversion to meth. Such products, the challenger noted, can represent a major advance in public health and safety, but only if they remain effective when used as directed to treat patients’ nasal congestion symptoms.

In this case, the challenger contended that the Food and Drug Administration (FDA) identified Sudafed as the leading pseudoephedrine product in a 1985 Monograph and argued that consumers would understand ZEPHREX-D to be equivalent to SUDAFED.

The challenger argued that the formulation of ZEPHREX-D reduces its therapeutic efficacy and that, contrary to the advertiser’s claims, ZEPHREX-D does not provide “full efficacy” or “fast acting … 30-minutes” onset of relief.

The advertiser provided no direct clinical relief studies of ZEPHREX-D to support the thirty-minute claim. However, the advertiser did present evidence regarding bioavailability that reliably demonstrated ZEPHREX-D would, within thirty minutes of dosing, reach blood levels associated with onset of action and that blood levels would remain in the “maximum effect” range for the duration of the dosing period.

The advertiser argued that the claims at issue do not imply that ZEPHREX-D is somehow equivalent to SUDAFED and noted that SUDAFED PSE has not been advertised for many years, which would significantly reduce consumer awareness of the product and its relevance as a benchmark. Further, the advertiser contended, there is simply no information on which to conclude that consumers believe that every pseudoephedrine product is identical to SUDAFED.

Following its review of the evidence in the record, NAD determined that the advertiser established a reasonable basis for its claims that ZEPHREX-D “starts working to clear swollen nasal passages in as little as 30 minutes,” is “fast acting, going to work in as little as 30 minutes,” and provides “fast, effective relief.” NAD further determined that the advertiser established a reasonable basis for its “maintains full efficacy providing necessary clinical benefits for patients” claim.

The company, in its advertiser’s statement, said that it appreciated “NAD’s careful review of the scientific record and its thorough treatment of the challenge issues.”