Westport Pharmaceuticals supports 'fast-acting' claims for its Zephrex-D
NEW YORK — The National Advertising Division last week determined that Westport Pharmaceuticals, maker of Zephrex-D nasal decongestant tablets, can support the claims challenged before NAD by Acura Pharmaceuticals, the maker of Nexafed, a competing product.
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.
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 30-minute claim. However, the advertiser did present evidence regarding bioavailability that reliably demonstrated Zephrex-D would, within 30 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.
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.
NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.
