FDA approves Phadia’s allergy diagnosis test
PORTAGE, Mich. Phadia on Thursday announced the recent Food and Drug Administration clearance of ImmunoCAP Rapid, the first point-of-care test to assist in the diagnosis of allergy in the practitioner’s office.
“This is another significant step in our mission to make ImmunoCAP testing available to all the clinicians managing patients with allergic disease, including asthma and rhinitis,” stated Michael Land, president of Phadia US. “In an era when the prevalence of allergy and asthma is described by many as ‘an epidemic,’ ImmunoCAP Rapid gives physicians access to additional clinical information that can help them arrive at a definitive diagnosis. They can also inform patients about the presence or absence of allergic disease while they are still in the office.”
The original ImmunoCAP Specific IgE blood test technology measures Immunoglobulin E (IgE) antibodies to indoor, outdoor and food allergens in a small sample of blood.
ImmunoCAP was the first allergy test to be cleared by the FDA as a truly quantitative test for identifying allergen sensitization. Reducing exposure to a specific allergen that is the source of sensitization is recognized by the National Institutes of Health as one of the most important steps in the effective management of allergic asthma.
ImmunoCAP Rapid is designed to be used at the point of care. Needing only a small sample of whole blood taken from the fingertip, the single-use, disposable device provides a first look at the IgE profile for patients based on the 10 most common inhaled allergens in the United States.
The results are available in 20 minutes, allowing the practitioner to quickly make evidence-based decisions. In addition, this timeframe allows the practitioner and patient to discuss appropriate treatments, including targeted exposure reduction, while the patient is still in the office.
GSK launches new Tums Dual Action
PITTSBURGH GlaxoSmithKline Consumer Healthcare on Wednesday announced the launch of its Tums Dual Action, which contains magnesium hydroxide and 10 mg of famotidine (the ingredient most commonly associated with Johnson & Johnson’s Pepcid formulations), in addition to the Tums mainstay ingredient calcium carbonate.
“Tums Dual Action is a natural extension for the iconic Tums brand, offering a proven solution for occasional heartburn sufferers looking for long-lasting relief from a trusted source,” stated Jack Levy, Tums brand manager. “With it, heartburn sufferers won’t need to think about whether or not lunchtime heartburn will interrupt dinner, or whether they’ll be able to sleep without being bothered by heartburn.”
In addition to providing relief to occasional heartburn sufferers, Tums Dual Action can also help patients who experience breakthrough heartburn while taking other medications like proton pump inhibitors. Despite high compliance with PPIs, 46% or more of PPI users experience breakthrough heartburn, or episodes of heartburn between doses, often at night, GlaxoSmithKline stated.
TUMS Dual Action is currently available nationwide at drug, grocery and mass merchandise stores in both Berry and Mint flavors. The expected retail price for a 25-dose bottle is $8.99, and a 50-dose bottle is $15.49.
Through May 15, consumers also have the opportunity to play an instant-win trivia game at www.tumsdualaction.com. The virtual multiple-choice quiz asks consumers general questions about heartburn-inducing foods, and gives participants the opportunity to win one of 400 instant-win “dinner and a movie” prizes consisting of a $25 gift card for Movie Cash or Fandango and a $25 gift card to Brinker Restaurants (Chili’s Grill & Bar, Romano’s Macaroni Grill, On the Border Mexican Grill & Cantina or Maggiano’s Little Italy).
All players will be entered into a sweepstakes to win a grand prize weekend getaway to San Francisco, Chicago or New York.
OTC product sales increased 2.4% in 2008, new research reveals
LITTLE FALLS, N.J. Manufacturers’ sales of over-the-counter drugs grew by 2.4% to $18.3 billion in 2008, according to the latest research in Nonprescription Drugs USA 2008: Market Analysis and Opportunities from worldwide consulting and research firm Kline & Company, released Tuesday.
Private-label OTC medicines were up 8.2% over the same time period, within which antacids and allergy medicines posted the highest growth last year, driven primarily by increases in sales of private-label omeprazole (Procter & Gamble’s Prilosec OTC) and cetirizine (Johnson & Johnson’s Zyrtec).
Allergy, asthma, and sinus medications were up 17.3% as a result of strong sales from Johnson & Johnson’s Zyrtec brand switch from Rx-to-OTC, as well as its equivalent private-label cetirizine; feminine products was another area that grew 7.3% in 2008 as a result of strong sales growth of personal lubricants, as well as the Rx-to-OTC switch brand Plan B by Barr Laboratories.
“By contrasting the overall growth rates for OTCs with the growth rates for private-label products we can easily make the case that more Americans were seeking value and using private-label in 2008,” stated Laura Mahecha, industry manager at Kline’s Healthcare practice.
Not all categories suffer from higher private-label growth, however, as some are able to maintain growth for branded products.
“During tough economic times, consumers are willing to spend more for some brands they are loyal to and that offer good efficacy,” Mahechas said.
If consumers view brands as being a commodity or not offering special advantages, conversely, they may be able to make the trade-off to private-label.
“As the recession continues into 2009, we expect to see increased ‘value messages’ as part of branded advertising to combat the impacts of private-label erosion. Branded OTCs may use advertising messages to stress the brand’s value, efficacy, safety, and possibly longer-lasting doses, which translates into fewer doses and therefore, costs less,” Mahecha said.
According to preliminary research for Kline’s upcoming report Impact of Recessions on the U.S. OTC Market, past declines during recessions have not been particularly steep for the industry. OTC sales declined two years in a row — from 1999 to 2000 — with overall manufacturers’ sales dropping 0.6%, and then it declined again from 2000 to 2001 by 0.5%.