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Westport Pharmaceuticals supports ‘fast-acting’ claims for its Zephrex-D

BY Michael Johnsen

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.

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BJ’s Wellsley Farm coffee gets K-Cup treatment

BY David Salazar

WATERBURY, Vt. & WESTBOROUGH, Mass. — BJ’s members will now be able to brew the wholesale chain’s brand of coffee with their Keurig coffee makers.

A new partnership is making BJ’s Wellsley Farms coffee available as single-use K-Cups, the two companies announced Monday.

“It’s wonderful to officially welcome BJ’s into the family as a partner in the Keurig system,” Keurig’s U.S. sales and marketing president John Whoriskey said. “With the Keurig Brewed seal on each K-Cup pack, every cup of Wellsley Farms coffee will have the consistent quality and rich flavor that BJ’s Members have come to expect and love from Wellsley Farms.”

The Wellsley Farms Signature Blend K-Cups will be sold in packs of 84 at BJ’s locations and online for members.

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Study: Vitamin D and calcium combination may prevent Type 2 diabetes

BY Michael Johnsen

CHICAGO — Vitamin D and calcium supplementation along with diet and exercise may prevent Type 2 diabetes in prediabetic individuals who have insufficient vitamin D in their bodies, a study from India suggests. The results were presented Saturday at the joint meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.

Vitamin D deficiency has been linked to prediabetes, which is a blood-glucose, or sugar-, level that is too high, but not high enough to be considered diabetes. It is unclear, however, if bringing low vitamin D blood levels to normal through supplementation will affect progression to diabetes.

In the new study, every unit increase in vitamin D level after supplementation of the vitamin decreased the risk of progression to diabetes by 8%, the authors reported.

“Without healthy lifestyle changes, nothing works to prevent diabetes in at-risk individuals,” said the lead author, Deep Dutta, a research officer at the Institute of Postgraduate Medical Education & Research and Seth Sukhlal Karnani Memorial Hospital in Calcutta, India. “However, our results are encouraging because the addition of vitamin D and calcium supplements is easy and low in cost.”

“If our results are confirmed in a large multicenter trial,” Dutta said, “vitamin D supplementation would provide us with a new tool in the armamentarium of diabetes prevention strategies.”

The West Bengal chapter of the Research Society for the Study of Diabetes in India funded this study. Of 170 individuals with prediabetes who had not taken vitamin D supplements in the past six months, 125 had vitamin D deficiency or insufficiency, which the researchers defined as a vitamin D blood level (25-hydroxyvitamin D) of 30 ng/mL or less. These 125 study subjects were randomly assigned to 1-of-2 treatment groups. In the first group, 68 subjects received ready-to-mix, powdered vitamin D3 at a dose of 60,000 International Units once weekly for eight weeks and then monthly. They also received a daily 1,250-mg calcium carbonate tablet.

The other group of 57 subjects received only calcium supplements. Both groups received advice to eat a healthy, calorie-appropriate diet and to engage in brisk exercise for 30 minutes each day.

The researchers analyzed results for subjects who had at least a year of follow-up tests. After an average of nearly two years and four months’ follow-up, only 6-of-55 subjects (10.9%) in the group that received vitamin D plus calcium supplementation had become diabetic, whereas diabetes developed in 13-of-49 individuals (26.5%) in the calcium-alone group. Blood sugar levels reportedly became normal in about twice as many people in the vitamin D group as in the group that did not get vitamin D supplementation: 23-of-55 subjects versus 10-of-49 subjects, respectively (41.8% versus 20.4%).

At the end of the study, those who received vitamin D supplementation had much higher vitamin D levels in the blood and lower fasting blood-glucose levels compared with the other group. Every unit (i.e., 1 ng/mL) increase in vitamin D in the body was associated with a 5.4% increased chance of reversal to normal blood-sugar levels, Dutta reported.

He said the greater reversal to normal blood sugar in the vitamin D group presumably occurred through improvements in their insulin resistance and inflammation.

 

 

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