HEALTH

Reckitt Benckiser acquires K-Y

BY Ryan Chavis

SLOUGH, England — Reckitt Benckiser announced that it would acquire global rights to personal lubricant brand K-Y from Johnson & Johnson. The transaction is expected to close mid-2014.

K-Y started as a prescription medical device in 1917 before switching to the OTC category in 1980. K-Y will join Reckitt Benckiser brand Durex in the sexual wellness category.

Net sales of K-Y in 2013 totaled greater than $100 million. It is sold in more than 50 countries around the globe, with the United States, Canada and Brazil accounting for the top majority of 2013 sales.

 

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Ansell launches new sexual performance enhancer

BY Ryan Chavis

ISELIN, N.J. — Ansell, the makers of LifeStyles Condoms, announced the launch of Epic, a new sexual enhancement product for males.

Epic is a quick-drying topical spray that delays ejaculation by reducing the sensitivity of the penis. The spray features DermaSys technology, a patented transdermal delivery system which optimizes topical delivery through a highly effective absorption process. It also contains Lidocaine, a mild anesthetic that begins working almost immediately after application.

"According to our most recent Sexual Satisfaction Survey, nearly one-quarter of male respondents claimed to suffer from premature ejaculation, with 30% of females reporting they’d like sex with their partner to last longer," said Carol Carrozza, VP sales and marketing, North America for Ansell. "Research and consumer feedback consistently support the demand for sexual enhancement products like Epic, and we are pleased to provide this valuable resource for an improved sexual experience for both partners."

Epic is available at a variety of big box retailers across the country.

 

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Lipitor may be the first statin to switch to OTC

BY Michael Johnsen

It's finally happening. Pfizer has placed the ball at the line of scrimmage. And based on the X's and O's to come out of its Lipitor OTC actual-use study, Pfizer will be making its run with its eye on the ultimate prize — a successful Rx-to-OTC switch of a statin. 

Only this time, the Food and Drug Administration may not be as quick to sack Pfizer's switch attempt. With the advances and pervasion of health technology in the self-care space by way of smartphones and tablets; with the evolution of the pharmacist as a healthcare professional able to practice at the top of their license; and with the adoption of diagnostic tests like a cholesterol panel that can be physically administered in the pharmacy, consumers may finally get it right when self-selecting a statin. 

Because it's the consumer actual-use studies that have scuttled just about every statin switch attempt in the past. In the last switch of Mevacor, FDA advisory panelists determined the statin was safe enough for the self-care space. And it was effective. It's just that the consumers who would be right for an OTC statin didn't appropriately self-select. And if they can't appropriately self-select, what's the point, really?

But that may change with this switch attempt. In fact, the FDA has already seen how technology can improve the self-selection process when it comes to statins. Two years ago, before a panel of FDA officials who were exploring how to expand what conditions would be considered appropriate in the self-care space, GlaxoSmithKline presented a prototypical healthcare kiosk that channeled a patient through nine algorithms and assisted him or her in making an appropriate treatment decision for use of an OTC statin, in this case Mevacor — branded Cardiocare. It was the kind of proof-of-concept presentation that helped showcase to FDA what the next generation of switch might look like. 

Then there's the expanded switch paradigm factor. FDA just came off of a year in which it created two categories never-before-seen in the nonprescription space — overactive bladder and nasal corticosteroids. And with Merck's Oxytrol, indicated for overactive bladder, the FDA even went against the advice of its advisory panel, the simple majority of which had voted that overactive bladder was not appropriate for OTC (six were opposed, five were in favor). Proponents of the switch argued that women with overactive bladders may go years before consulting a physician and that an OTC option might encourage therapy sooner. That may be one of the tipping points for FDA — medicines available OTC, for certain conditions, may represent a greater good for the public.

And don't forget that as part of the Affordable Care Act, there is a significant cost associated with keeping statins as prescription only. You can bet the folks over at the Centers for Medicare and Medicaid Services and Tricare will be rooting for this statin switch. But then again, that's something that DSN has been saying all along. Here's what we wrote in 2011: "Under ObamaCare, the country becomes a much larger healthcare payer in 2014. OTC Lipitor could lower the cost of therapy from $4 to $5 per pill to a fraction of that — even cheaper than a generic version when you factor out the cost of the doctor visit that would be saved. The federal government stands to save a lot of money here if the Food and Drug Administration could change the way it thinks about an OTC statin." 

At the end of the day, a Lipitor switch would be a significant boon to purveyors of the OTC category. Some analysts have predicted that an OTC Lipitor would become the first de facto blockbuster drug in the nonprescription space, which is defined as having sales in excess of $1 billion. Pfizer is only at the very beginning in its drive for the ultimate switch touchdown, but it's likely Pfizer will be posting seven points on the board when it's all said and done. 

 

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