HEALTH

Cough-cold rewind: 20 years of growth

BY Michael Johnsen

This year, ECRM celebrates 20 years of successfully pairing buyers and sellers across the consumer packaged goods industry. As part of that celebration, and in correlation to the ECRM Cough-Cold, Analgesics and Allergy event, DSN editors thought it’d be a good idea to look back through the last 20 years of the cough-cold business at retail.

In that time, the sales of cough-cold/allergy tablets and liquids have grown from a $2.4 billion base into a $5.4 billion category. What follows is a review of the big product launches and trends that have driven the cough-cold category over the last two decades.

1995-1999

•    In what has since become a case study in how to successfully obtain consumer impressions without breaking the bank, CNS placed Breathe Right on the map with a super-endorsement by NFL players participating in Super Bowl XXIX in 1995. “Eight of the game’s 10 touchdowns were scored by players wearing the device,” wrote DSN’s Mike Troy. “Close-ups of the 49ers’ Jerry Rice and Ricky Watters and the Chargers’ Natrone Means, all of whom wore a Breathe Right strip, were shown repeatedly to millions of viewers.” The nasal strip that helps open nasal passages for better breathing was sent to NFL team trainers to sample as part of its launch strategy, and the rest
is history.

•    McNeil Consumer’s nasal spray Nasalcrom (today managed by Prestige Brands) is approved for OTC status on Jan. 6, 1997, marking the first time an inhaled anti-inflammatory drug is approved for OTC, and the first time an OTC product can claim to prevent allergy symptoms.

•    Zinc is heralded by the consumer press as a cough-cold wonder drug that is clinically proven to shorten the duration and severity of the common cold. The hubbub created out-of-stocks as consumers clamored for such successful zinc products as Gel Tech’s Zicam (today managed by Matrixx) and Quigley’s (now ProPhase Labs) Cold-Eeze.

2000-2004

•    Such homeopathic companies as Hyland’s begin targeting the mass allergy market with product launches, including Hyland’s Sinus. Allergy was one of the first categories in which retailers merchandised homeopathic remedies alongside allopathic medicines.

•    Retailers also begin carving out children’s cough-cold as a destination within the set. “Children are a viable market because it has not been tapped,” reported Barbara Kuhn, then assistant VP merchandising at Happy Harry’s, in September 2000. The new focus corresponded to a number of new product launches, including Children’s Motrin Cold and Dimetapp Get Better Bear freezer pops.

•    The cough-cold category was rocked by the removal of phenylpropanolamine-containing products from shelves in October 2000. PPA had been on the market as a decongestant for about 50 years prior. The Food and Drug Administration asked manufacturers to voluntarily remove the ingredient from the market because of an increased risk of hemorrhagic stroke in women.

•    A pair of Food and Drug Administration advisory committees recommended the Rx-to-OTC switch of three second-generation antihistamines — Claritin, Allegra and Zyrtec — on May 11, 2001. The genesis of the switch application was a Citizen’s Petition filed by Wellpoint Health Networks of California.

•    In December 2002, Schering-Plough (now Merck) switched Claritin (loratadine) to over-the-counter. It marked the first second-generation antihistamine to make the crossover and brought with it an approximately $2.6 billion book of business from Rx to OTC aisles. It was also one of the first switches that caused healthcare payers to move the remaining Rx-only antihistamines to non-preferred status in an effort to encourage patients to self-treat their allergies.

•    Oklahoma passes bellwether legislation that restricted the sale of products containing pseudoephedrine to behind the pharmacy counter in April 2004.

2005-2009

•    Adams Respiratory made a splash onto drug store shelves with its “stealth switch” of the guaifenesin product Mucinex (now managed by Reckitt Benckiser). Adams officially applied for the rights to market extended-release guaifenesin as an OTC product and won market exclusivity — forcing many guaifenesin products off the market. The brand then took advantage of its market exclusivity with a successful ad campaign that brought Mrs. Mucus into America’s lexicon.

•    The power of Oprah at the OTC shelf was realized when she mentioned Knight-McDowell’s Airborne (now managed by Reckitt Benckiser). “The appearance on ‘Oprah’ certainly contributed to the brand’s phenomenal growth over the first half of this year’s cough-cold season — up 254.5% to reach drug channel sales of $10 million for the 12 weeks ended Jan. 23, [2005], according to IRI,” wrote DSN on March 7, 2005.

•    The summer of 2005 saw PSE-containing products restricted for sale behind the pharmacy counter. What’s more, pharmacists were responsible for enforcing restrictions on the amount of PSE that can be purchased in any given month. Since then, the Consumer Healthcare Products Association has helped build the National Precursor Log Exchange, enabling pharmacies to electronically track the sale of PSE products in realtime in those 29 states where NPLEx operates.

•    Oregon passes legislation identifying PSE-containing products as prescription-only in what amounts to a reverse switch. Mississippi has since passed similar legislation.

•    CHPA begins proactively disseminating “toolkits” regarding the teenage abuse potential of dextromethorphan. In addition to getting all stakeholders — parents, teachers and healthcare providers, along with the teens themselves — in on the conversation, the association advocates an age restriction ban on the sale of DXM-containing products to adults 18 years and older.

•    In October 2007 the FDA begins exploring the safety of several cough-cold ingredients in children. At issue was the lack of pharmacokinetic studies in pediatric populations to determine appropriate dosage limits. The industry has since voluntarily changed cough-cold labels to direct parents to seek a doctor’s advice for children under the age of 4 years. The questioning of safety and efficacy in kids cough-cold products gives a big boost to homeopathic alternatives.

•    McNeil Consumer Healthcare brings the second second-generation antihistamine to market with Zyrtec in what has since become a model switch. Within days after the approval, Zyrtec was dotting the shelves of all stores across the supply chains of Walmart, Walgreens, Rite Aid and CVS/pharmacy.

•    H1N1 changes the dynamics of the cough-cold season with flu incidence happening as early as March and peaking in the fall. The pandemic is credited with helping to drive acceptance of the flu shot within the pharmacy setting.

2010-PRESENT

•    In March 2011, Allegra is the last of the three second-generation antihistamines to make it to the market.

    GoJo prepares to launch Purell Advanced hand sanitizers in time for the 2011-2012 cough-cold/flu season in a move that will bring brand relevance back to a commoditized category. Sales of hand sanitizers as part of the cough-cold mix became significant with the 2009 H1N1 epidemic.

•    The FDA removes the $100-million OTC asthma inhaler Primatene Mist from the market. The agency removed all inhalers containing chlorofluorocarbons from the market. Homeopathic remedies from King Bio and Homeolab have since filled the space.

•    In an attempt to thwart methamphetamine production associated with the purchase of PSE products, a continuing problem even after PSE has been moved behind the counter, Westport Pharmaceuticals launches Zephrex-D, a PSE-based decongestant that’s “meth resistant.” Acura Pharmaceuticals also launches a meth-resistant SKU called Nexafed.

•    All 2013 Ford models are enabled to access the Pollen.com’s Allergy Alert app to give drivers a safe way to check for potential allergens in the area. “Mobile health apps are changing the way consumers manage their own wellness,” said Doug VanDagens, global director of Ford Connected Services.

•    Now on store shelves, Chattem’s Nasacort Allergy 24HR is the next allergy remedy expected to generate significant incremental revenue. That switch is expected to open the door to a new class of allergy medicines — nasal steroids. “Whatever happens to one of the nasal steroids will happen to all eventually,” said David Seltzer, chairman, CEO and president of Hi-Tech Pharmacal.

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CDC: Flu rates on the decline but still prevalent across 13 states

BY Michael Johnsen

ATLANTA — While flu activity declined slightly from the week prior, incidence of influenza-like illness rates remained above the national baseline for the week ended Feb. 8, the Centers for Disease Control and Prevention reported Friday. 

Six states were still experiencing high ILI activity, including Arkansas, Connecticut, Kansas, New York, Oklahoma and Texas.

Seven states experienced moderate ILI activity, including Alabama, Delaware, Hawaii, Louisiana, Maryland, New Jersey and Virginia.

Nineteen states and New York City experienced low ILI activity while 18 states experienced minimal ILI activity.

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Study: Vitamin D supplementation may augment chronic hive therapy

BY Michael Johnsen

OMAHA, Neb. — A study by researchers at the University of Nebraska Medical Center found that vitamin D as an add-on therapy could provide some relief for chronic hives, a condition with no cure and few treatment options.

Jill Poole, associate professor in the UNMC Department of Internal Medicine, was principal investigator of a study in the Feb. 7 edition of the Annals of Allergy, Asthma and Immunology. The two-year study looked at the role of over-the-counter vitamin D3 as a supplemental treatment for chronic hives.

Over 12 weeks, 38 study participants daily took a triple-drug combination of allergy medications (one prescription and two over-the-counter drugs) and one vitamin D3, an over-the-counter supplement. Half of the patient’s took 600 IUs of vitamin D3 and the other half took 4,000 IUs.

Researchers found after just one week, the severity of patients’ symptoms decreased by 33% for both groups. But at the end of three months, the group taking 4,000 IUs of vitamin D3 had a further 40% decrease in severity of their hives. The low vitamin D3 treatment group had no further improvement after the first week.

“We consider the results in patients a significant improvement,” Poole said. “This higher dosing of readily available vitamin D3 shows promise without adverse effects. Vitamin D3 could be considered a safe and potentially beneficial therapy, she said. “It was not a cure, but it showed benefit when added to anti-allergy medications. Patients taking the higher dose had less severe hives — they didn’t have as many hives and had a decrease in the number of days a week they had hives.

Poole said the study didn’t include patients with kidney disease or those with calcium disorders.

The study was funded through a $50,000 grant from the American College of Allergy, Asthma and Immunology and the UNMC Clinical Research Center.

Researchers are considering doing a larger study.

An allergic skin condition, chronic hives create red, itchy welts on the skin and sometimes swelling. They can occur daily and last longer than six weeks.

 

 

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