HEALTH

BMR helps relieve migraine and headache symptoms

BY Michael Johnsen

COLD SPRING HARBOR, N.Y. — Cirrus Healthcare Products has created a new migraine relief product that is clinically proven to reduce the duration, intensity and discomfort of migraine headaches. When used with other migraine medication, BMR Barometric Migraine Relief has been shown to help provide relief for migraine and headache symptoms in 81% of sufferers, according to data from a clinical study conducted by Princeton Consumer Research.

(To view the full Category Review, click here.)

BMR is designed for all types of headaches caused by changes in barometric pressure, including migraine, sinus and other severe headaches. According to WebMD, changes in barometric pressure are the leading cause for weather-related headaches.

In addition, migraine sufferers also can help manage future headaches by monitoring the Migraine Alerts feature at AccuWeather.com and being prepared to use BMR when symptoms start.

“With BMR, you can weather your migraine,” Lanny Lewis, Cirrus’ SVP business development, said.

BMR will be introduced in December and is expected to roll out to retailers in early 2016.

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Switch products drive dollar growth

BY Michael Johnsen

There has been a lot of hope placed in the ability of recently switched products to drive significant growth within the OTC sector, and with good reason. Recently switched products Nexium and Flonase brought in a combined $520.4 million for the 52 weeks ended Oct. 4, according to IRI.

(To view the full Category Review, click here.)

Having first hit the market in 2014, Pfizer’s Nexium 24HR has become the best-selling heartburn remedy on the market with more than $292.5 million in annualized sales. And early in 2015, GlaxoSmithKline’s Flonase rocketed to the top of the best-selling lists across cough, cold, allergy and sinus with the introduction of its nasal corticosteroid, bringing $227.9 million in almost purely incremental dollars to the category.

But after Pfizer this summer pulled the plug on its Rx-to-OTC switch of Lipitor, the question has to be asked, is switch dead?

“[Lipitor] was a linchpin for a lot of these chronic conditions and more complicated switches,” said Laura Mahecha, industry manager health care at Kline Group. “A lot of people in the industry, even if they didn’t have a cholesterol-lowering drug, were waiting to see if [Pfizer] could get a statin approved.”

As a failed investment, that might stifle future switches, Mahecha suggested. “It makes companies really conservative in terms of investing resources.”

“There is still a lot of interest,” countered Robert Sanders, EVP healthcare practice leader at IRI. “[But] there has to be a different business model to get after switches. It’s going to require either diagnostics or some other mechanism for the Food and Drug Administration to feel more comfortable that people can self select.”

But switch is certainly not going to be the same growth driver in the near term, at least in 2016, as it has been in recent history. “Certainly nothing like we saw with Nexium and Flonase,” he said.

Longer term, switch will remain a viable growth engine. In 2012, the FDA established the Non-Prescription Drug Safe Use Regulatory Expansion Initiative, and since that time the FDA has created two new categories with its switch approvals. “Back in 2013, they switched Oxytrol, which actually created a new category for overactive bladder within the OTC marketplace,” noted David Montfort, director of insights for the Edgewood Consulting Group, during a recent GMDC Connect presentation on switch. “[And] in 2013, they also approved Nasacort, which is actually the first nasal steroid product approved to be sold OTC.”

Montfort outlined six factors that help drive every switch success story. From the manufacturer’s perspective, there is having a strong heritage as a prescription brand, speed to market and consumer marketing. A strong heritage is especially important — as much as half of year-one sales volume can be attributed to prior prescription patients, Montfort said.

And from a retailer’s perspective, key factors are preparing for launch beforehand, speed to shelf and in-store execution. “What Edgewood would recommend is a preemptive category management approach whereby a lot of this best practice analysis work is done prior to the product launching, such as shopper insights, speed to shelf and ensuring impactful retail execution,” he said.

“Speed to shelf really does effect trial and repeat rates for a switch product,” Montfort added. “Those retailers able to get the product to market quickly, actually have higher initial trial rates, and those higher trial rates ultimately result in higher repeat rates. Ultimately, they’re able to build a much bigger business more quickly based on getting the product to the shelf in an expedited fashion.”

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VMS industry requests FDA dedicate greater resources to regulating industry

BY Michael Johnsen

WASHINGTON – Six associations representing the dietary supplement industry last week requested that the Division of Dietary Supplement Programs be elevated to an “Office” within the Food and Drug Administration. 
 
“We believe that the elevation of DDSP to an 'office' would provide appropriate regulatory attention to the growing industry and increase FDA’s enforcement activities and priorities,” the trade associations said. “In addition, we believe such a reorganization would enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency.”
 
The trade associations also expressed their concern over “blatant” criminal activity in the supplement industry. “We believe that elevating DDSP’s status to an Office would help increase FDA’s abilities to take more aggressive enforcement action; raise the visibility and attention for dietary supplement safety and compliance measures at FDA; and better utilize CFSAN’s enforcement resources.”
 
The six associations include the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance. 
 
 
 
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