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Published on May 12th, 2013 | By: pwray@ceramics.org

36

GSK drops ball with puzzling US release of Sensodyne ‘Repair & Protect’ sans 45S5 glass

Published on May 12th, 2013 | By: pwray@ceramics.org

Looking for innovative NovaMin/Bioglass active ingredient in Sensodyne Repair & Protect? US consumers will not find it in the toothpaste that just went on sale. Credit: ACerS.

In the last few weeks, GlaxoSmithKline finally (and relatively quietly) began the sale of its renowned Sensodyne Repair & Protect toothpaste in the United States, and if you think maybe I am going to write one of those good news/bad news stories, I am not. There is no good news here and I have scratched a bald spot in my wrinkled gray scalp over the past five days trying to make sense of GSK’s decision.

 

There are a lot of international readers of this blog, so some background is necessary to avoid confusion for those who live outside North America. For years, GSK has sold a unique and remarkable toothpaste outside North America called Sensodyne Repair & Protect. Materials scientists, particularly those that work with advanced glass materials, took interest in this Sensodyne product because it contained a form of the 45S5 Bioglass invented by Larry Hench. As far as I know, it was the first broad-based consumer product that contained a bioactive ingredient that was designed to stimulate the body to rebuild dental tissue that, heretofore, was not rebuildable.

 

Repair & Protect was reported to be a godsend to people (including most adults) whose teeth have become annoyingly sensitive to heat and cold. Typically, the sensitivity occurs as one ages because some of the tooth enamel gets worn off over the years, which exposes the dentinal tubules that connect with the tooth nerves.

 

The 45S5 glass particles in Repair & Protect solve this by triggering an ionic reaction. When the glass particles contact saliva and water, the glass releases calcium and phosphate ions that form a calcium phosphate layer. The body then converts this to hydroxyapatite, which creates a physical barrier over the tubules much like the original enamel. Brush twice a day with Repair & Protect and after two weeks the heat/cold sensitivity disappears.

 

Just for the record, it wasn’t a direct path from Hench’s lab to the innovative toothpaste. Hench licensed his 45S5 to a US startup company, NovaMin, created by a group of dentists who saw the enormous potential for the glass in dental applications. GSK also saw the enormous potential and bought NovaMin for $135 million three years ago.

 

Quickly, GSK started bringing Repair & Protect to markets in Europe, Asia, Australia, and South America, to name a few. Anecdotally, the product seems to have been well received by consumers (despite being priced at a premium) and dental professionals. I have not read any definitive reports on sales, but according to a December 2011 story on the Consumer Goods Technology website, “As of September 2011, GlaxoSmithKline had sold 20 million units of Sensodyne Repair & Protect in more than 30 international markets.” Not bad for a few months of sales.

 

And it got better. According to GSK’s 2011 Annual Report, its Sensodyne Sensitivity & Acid Erosion business “grew 16%, driven by the launch of Sensodyne Repair & Protect… . Since its launch in February 2011, Sensodyne Repair & Protect has been available in 30 markets across Europe, Asia and the Middle East, with 20 additional launches planned for 2012. The Sensodyne franchise has registered double-digit growth for 11 consecutive quarters.”

 

GSK’s 2012 Annual Report (pdf) makes it sound like the toothpaste quickly became one of its cash cows:

“The Oral care category led growth at 8% versus market growth of approximately 4%. Sensodyne became the business’s first ‘billion-dollar brand’ in 2012, boosted by the global roll-out of Sensodyne Repair & Protect and the launch of Sensodyne Repair & Protect Whitening and Extra Fresh.”

But, one of the obvious omissions, marketwise, was that GSK wouldn’t (or couldn’t) sell Repair & Protect in the US marketplace. The reason? Over the years I have spoken with several glass experts at various ACerS meetings and the story they gave was nearly always the same: GSK couldn’t get FDA approval. As recently as two months ago, I was told by someone involved with the product’s development—but not the FDA process—whose understanding was that US sales was delayed because the regulatory agency was fine with the toothpaste composition, but uneasy with the term “repair.” Regardless of the cause of the delay, you couldn’t buy similar Repair & Protect in the US. Even online outlets, such as Amazon, refused to ship the product to the US.

 

So far, I have been unable to confirm the story about the FDA delays, and I don’t know if there is any truth to it.

 

What I do know is true is that in the past three weeks, I suddenly starting hearing from friends and ACerS contacts that they either had seen Repair & Protect commercials on US networks or had seen an actual box of the product in US retail outlets. Great, I thought. No more having to sneak it into the US!

 

But, in fact, I still was a little skeptical because just a week or so ago, when he was receiving the Toledo Glass Award, Larry Hench stated something to the effect that Repair & Protect was unavailable in the US. Coincidentally, my colleague Eileen De Guire excitedly shot out an iPhone picture of a box of Repair & Protect that she just found in a drugstore in Michigan.

 

Weird, I thought. Then even my chiropractor on Monday mentioned to me that he had seen an ad for the toothpaste.

 

Curiosity fully piqued, I jumped online to look for GSK’s press release about the start of Repair and Protect sales in the US. There wasn’t one. I did look for the product on GSK’s website and was eventually directed to the US Sensodyne website. Indeed, the main story proclaimed, “Now a Sensodyne toothpaste that can actually repair sensitive teeth.” A-ha! It is true.

 

But… there was also button to click on to “Learn more about Repair & Protect.” I clicked hoping to read carefully composed marketing copy about the benefits of the NovaMin/45S5 glass particles in Repair & Protect like that on the UK Sensodyne website.

 

Boy, was I disappointed. Instead of a discussion of NovaMin, the webpage discusses the benefits of stannous fluoride. Stannous fluoride! The webpage also has video from a dentist whose chopped up testimonial has him saying, “I’m always open to new advances…” Now, if you are old enough to remember the old “Crest with Fluoristan” commercials, you know that there is nothing “advanced” about stannous fluoride.

 

I was certain there was a mistake. I was so certain there was a mistake that I went out to my local CVS to buy a tube so I could read the ingredients myself. Sure enough, the only active ingredient is “stannous fluoride 0.454%.”

 

I should have been tipped off by the relatively quiet start of the sales of Repair & Protect in the US. Yes, GSK/Sensodyne is running TV ads in the US, but it defies logic that a major consumer product company rolls out a “billion-dollar” brand in a huge market without 1) a press release and press push, 2) social media promotions ($1 off coupon campaigns don’t count), 3) an education campaign aimed at dentists, and 4) some nearly-over-the-top promotional events. But, that is what it appears GSK is doing.

 

I twice requested an interview with a GSK representative to explain why GSK switched the formulation for the US version of Repair & Protect and why there was such a lackluster product rollout. GSK refused to provide an interview opportunity. Instead, I had to settle for an insipid exchange of emails with GSK’s media contact for North America consumer products, Deborah Bolding.

 

Bolding wrote to me, “Sensodyne Repair and Protect is a new product here in the US and does not contain NovaMin. The FDA approved the formulation. We work with regulatory authorities in each market on formulations for the specific product to be marketed and sold in that specific market. There are variances by market depending on the local regulatory body and other factors.”

 

When I asked for examples of other markets where Repair & Protect doesn’t contain 45S5/NovaMin, she didn’t respond other than to write, “As mentioned earlier, formulations vary by market because each market has its own regulatory authorities.”

 

When I requested that Bolding supply me contact information of the dentist featured in the testimonial video, Bolding responded, “I am pleased that I could address a number of your questions regarding Sensodyne Repair & Protect here in the US. Unfortunately, further comment will not be available on our strategy, rationale and future plans.”

 

So, advanced materials aficionados, I am sorry to conclude that if you want to buy Sensodyne Repair & Protect in the US, save your money and buy some Crest. If you want “real” Repair & Protect, you are still going to have to go abroad to buy it.

 

I am confident the story eventually will emerge about why GSK would invest $135 million in a US startup (NovaMin), but not leverage the technology to create a powerful product in the startup’s home nation—all at the risk of diluting and potentially damaging the Repair & Protect brand reputation outside the US. GSK is a publicly traded company, and maybe analysts and stockholders should start asking.


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36 Responses to GSK drops ball with puzzling US release of Sensodyne ‘Repair & Protect’ sans 45S5 glass

  1. Pamela Grow says:

    Interesting and thanks for clearing this up. I had had a subscription for the Dr. Collins Restore toothpaste — loved the stuff. I wondered what happened. After reading your article I was able to find some of the Sensodyne repair toothpaste on ebay from a UK seller. Dr. Collins is now as high as $100 on eBay.

  2. AJ says:

    I live in the US, and I just received 4 tubes of the real “Repair and Protect” with Novamin that I ordered from Amazon.co.uk (first attempt), so it seems there’s no problem doing that anymore (unless I was lucky somehow?).

    However, I was actually a little disappointed to discover that the non-US variety DOESN’T contain stannous fluoride along with the Novamin, because it was my understanding that stannous fluoride is the more effective fluoride compound (they’ve also worked out the issues with staining and funny taste), but at least it does contain the Novamin (in addition to sodium monofluorophosphate).

    • Eileen De Guire says:

      Maybe you can mix some US R&P with some UK R&P to capture the “best of both worlds?”

      Eileen

  3. phdchristmas says:

    The American Dental Association’s number one goal is to get more money in the pocket of dentists. After all the ADA is made up of dentists. Naturally ADA lobbyists will convince the FDA (via lumps of money) to not approve a breakthrough bioactive ingredient that can “rebuild enamel” when we as Americans are commonly told by our dentists that rebuilding enamel is impossible. Going through the implant/ceramic fitting/filling route is what makes dentists money.

    Picked up Sensodyne Repair & Protect while in Manila for a project, I’m liking the results so far.

  4. Robin says:

    Thanks so much for this article. I saw the commercial today on US television. My interest was immediately piqued when the man on the screen said that the Sensodyne Repair and Protect actually helps to rebuild enamel and stop the sensitivity. Great, I thought. But, being the skeptic that I am, I decided to check it out online. I found your article and the truth. The GOOD NEWS here? I was able to go online to the UK website lifeandlooks.com and purchase 6 tubes of the Repair and Protect WITH Novamin. I enlarged the photo of the product and it has written across the package, “Powered by Novamin”. Unfortunately, it does have fluoride, but, I’m still a happy camper.
    I got a 5% discount with the code: EXTRA and free shipping to the US. All a good deal for a sum total of just $28.02 for the 6 tubes.

    Thanks again!~

  5. Patricia Fenkell says:

    Ah ha! It seems GKS has been busy dealing with their misdeeds elsewhere: Exclusive: Glaxo whistleblower goes public with shocking details of bribery, marketing fraud and other pharma crimes

    Learn more: http://www.naturalnews.com/036499_Glaxo_whistleblower_bribery.html#ixzz2hpKIG35Zhttp://www.naturalnews.com/036499_Glaxo_whistleblower_bribery.html

    We wouldn’t want the bad guys to succeed for our own benefit. It’s certainly a loss, but… I will tell you that I’m emailing carrots, with your article attached, out to those who might further investigate. That several somethings were rotting in Denmark, Mike Adams exposed, I wouldn’t be surprise if there’s more – the possible involvement of the ADA, fluoride developers or other money. I mean $135 million? Next to a 3 billion dollar fine I guess that’s chump change.

  6. Patricia Fenkell says:

    Thanks so much for posting your investigations. I was so pleased to find out about calcium sodium phosphosilicate in Burt’s Bees toothpaste. I’ve just received the news that they’re discontinuing their product. (Stated reason,”sales volume was not substantial enough to warrant our continuing to market this product.” Suspicious!) In looking at the list of US toothpastes doing the same and only Dr. Collins, with sodium lauryl sulfate, at $35 a pop and ReNew (sadly with fluoride and only available to dentists). I see NovaMin also comes in a powder form – no doubt also only available to dentists. I find this very frustrating. So yes, I’m considering purchasing from India or Europe…even Brazil… It makes no sense that GSK would spend 135 million only to hold firm to a name that the FDA doesn’t approve of instead of changing it.

    You might appreciate “My experience: Oravive with NovaMin” and excellent ensuing commentary. http://xenophilia.com/my-experience-with-novamin/#comment-10965 They’ve really done their homework.

    I may have found a sudo-subsitute, Colgate-Sensitive-Pro-Relief-Desensitizing-Paste with “Pro-Argin™ Technology contains calcium carbonate and arginine, an amino acid naturally found in saliva3″ I don’t see that it contains fluoride or SLS. Still, we had hold of the holy grail, or so it seemed… Depressing indeed!

    SootheRX http://multimedia.3m.com/mws/mediawebserver?6666660Zjcf6lVs6EVs66Spd_COrrrrQ- and NuCare Root Conditioner http://www.dimensionsofdentalhygiene.com/ddhright.aspx?id=453 contain NovaMin however, they appear to be the realm of dental practitioners. FYI, products listed on wikipedia containing NovaMin: http://en.wikipedia.org/wiki/NovaMin

    Has anyone found a new source? Any luck importing?

  7. JLM says:

    This guy is head of the Sensitivity Products Division for GSK. So why don’t we ask him what’s going on?

    stephen.a.makin@gsk.com

  8. JLM says:

    To make matters worse the RX only 5000ppm paste from Dentsply has been discontinued. I’m trying to find out why. It was/is called Sensodyne NUPRO.

  9. Scott Johnson says:

    Hi Peter! I found out about this ingredient while I was searching for toothpaste on eBay. I can’t say it has to do with the FDA because there was Dr. Collin’s Restore toothpaste. On their website it says it’s being ‘reformulated.’ In essence it’s off the market currently. I wonder if it has anything to do with GSK buying out the active ingredient. However, on eBay they have a GSK version where you can buy it with NovaMin (their brand). There is other toothpastes from USA that have the active ingredient. I don’t think it has anything to do with the FDA at all.

  10. sylvia.m.johnson@nasa.gov says:

    I bought some in England last month because I had heard Larry speak. I love it!. I had not seen the blog, and saw the toothpaste in the store the other day and read the ingredients carefully, placed it back on the shelf and wrote to a friend to bring me some.
    I fully intend getting a supply and giving it as gifts for Christmas!

  11. Tammara says:

    I started using the Repair and Protect one month ago with the Stannous Floride and it has caused horrible lesions on my gum line and extreme tooth sensitivity.

    • Sam dunne says:

      I started using sensodyne repair and protect about a month ago! Had a check at my dentist my teeth are fine and oral hygiene is good since using it I’ve found my mouth and gums have been dry and sore so decided to see what happens when I stop using it! I’ve had bad pain in my mouth gums travelling up into my eyes! I’m glad your government banned it I’ve read of lots of brits on the internet having the same problem!

  12. Garrett says:

    The best option for most is to get Dr. Collins’ Restore while it lasts, as it has been recently discontinued to be “reformulated” sans Novamin. So whatever licensing deal was in place appears to have expired. Plus Restore, while it does not have a perfect ingredients list, contains no dangerous and toxic fluoride. Burt’s Bees, a Clorox subsidiary, does NOT use Novamin in their toothpaste. Their version of calcium sodium phosphosilicate is different or in a very small amount and their product absolutely does NOT have the same effects as Novamin-infused toothpaste.

  13. Michael says:

    Repair and Protect has Novamin here in Canada.

  14. superstud says:

    I tried the novamin toothpaste(repair n protect) in the last 3 monthes[bought it from outside US]
    * it fixed sensitivity issue
    * i can actually feel very smooth layer of enamel , i imagine its the rebuilt surface
    * it didnt fix white spots due to significant loss of enamel in some areas
    * im waiting for my next dentist appointment to get an idea about my teeth general condition

    plus im using colgate total seperately to fight bacterial activity.

  15. Dave says:

    Thanks Bob. Just ordered some.

  16. Bob says:

    Sensodyne with NovaMin appears to be available in the US via this website: http://www.lifeandlooks.com/Models.aspx?ModelID=15093

    • Datagg says:

      Bob, yes I ordered some the other day from there. Its in the UK, free shipping so that is great.

    • P. Hughett says:

      Thank you thank you Bob! I’ve been using Dr. Collins Restore and it literally saved my teeth. I am outraged that the product is no longer available in the US and only discovered Dr. Collins in reformulating not to improve, but because they have to remove the one ingredient that has saved me thousands in dental bills. I just paid over $200 to gather a few of the last remaining tubes left. Hurts the pocketbook, but not as much as my dental bills will if I stop using this miraculous product. Shame on those responsible, most likely greed at the bottom of this terrible news.

      And once again, many thanks to Bob for sharing the info!

    • Nordo says:

      Thank you for the link to the LifeandLooks site. I just ordered one tube of this to try it out.

      However, the product also contains sodium lauryl sulfate (SLS), a foaming agent found in most toothpastes. I stopped using toothpastes with that ingredient 5 years ago due to suffering from frequent canker sores. Since then I have been using Sensodyne Original, and now I hardly ever have those sores. I am interested in trying the Novamin though, so this appears the only option.

      Or, are you aware of any other toothpaste which has Novamin but not SLS? It looks like Dr. Collins Restore used to be like this, but is no longer available.

  17. Datagg says:

    I am watching this page like a hawk. very informative page. i bought a couple of tubes of repair and protect last week and am very disappointed it isn’t what i thought it was. I just ordered today a few tunes of the real stuff from the UK. Hopefully we will get this in the US soon or it will be overseas ordering for this if it works as it sounds.

  18. Rita Foley, DDS says:

    Both Burts Bees dentifrices contain calcium sodium phosphosilicate. I believe Novamin was private labeled to them prior to the GSK deal.

    I, too, am waiting for a reply from GSK. Such a disappointment. The rep told me it wasn’t in the current product because it can’t be sold in the US without a prescription. So I mentioned Burts Bees. If the fluoride concentration is <5000 ppm, the RX dose, the product should be available OTC.

    I think showing the tubule occlusion TV advertisements, as if it was a true remineralization product instead of just stannous fluoride, are misleading. GSK is better than this.

  19. rrrcryst says:

    The Sensodyne Professional package I have has 5000ppm fluoride ion with NovaMin. The box says powered by Novamin, but only active ingredient sodium fluoride 1.1%, Listed in Other ingredients,one of which is calcium sodium phosphosilicate (NovaMin). When I spoke to my dentist he indicated that all the rights to the original NovaMin were not sold and there was another Toothpaste brand and several other products that were still controlled by the original group of dentists that had bought rights from Larry Hench. I do know that when a toothpaste has 1.1%fluoride it is a prescription toothpaste. Unfortunately I don’t remember the name or names of the other non-GlaxoSmithKline company mentioned. Maybe someone else has a knowledgeable dentist. It could be that GSK can only sell the prescription brand in the USA.

  20. Ron Bevins says:

    Is the better version of Repair & Protect sold in Mexico?

  21. Peter Wray says:

    Lenore – I have no idea what you are saying. There is clearly some legal differences regarding labeling between the US and UK, but, for the record, the “ingredients” listed in the UK version of Repair & Protect are: “Glycerin, PEG-8, Silica, Calcium Sodium Phosphosilicate (NovaMin), Sodium Lauryl Sulfate, Sodium Monofluorophosphate, Aroma, Titanium Dioxide, Carbomer, Sodium Saccharin, Limonene, Linalool. Contains: Sodium Monofluorophosphate 1.08% w/w (1450 ppm fluoride).” In addition, the UK marketing materials use the wording “powered by NovaMin” and “advanced NovaMin technology”, so that pretty strongly indicates what at least one of the “active ingredients” is, and then, of course there is the fluoride. But no where does it list NovaMin as an “inactive” ingredient. NovaMin is also not listed in the “inactive” ingredients in the US (“glycerin, PEG-8, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin”). The US inactive ingredients also do not somehow constitute a backdoor equivalent of NovaMin, either, as some of my correspondents have suggested. Proof of NovaMin’s “effectiveness” for dental sensitivity is already available in peer-reviewed journals, but I still have my doubts about the exact nature of an FDA disagreement, if that was the main factor at all.

  22. Leonore C. Wells says:

    Actually, it makes perfect sense that Sensodyne doesn’t market the Novamin version of Repair & Protect in the US as an over-the-counter product. Looking at the ingredients list, they include Novamin as an inactive ingredient. That isn’t acceptable under the USFDA rules. They would have to list it is an active ingredient. Then Sensodyne would have to prove that it works to use their advertising from the UK and Canada.

  23. Amy says:

    Dr. Collins Restore toothpaste sold in the US claims on its website to contain NovaMin. How can this be so?

    • Dennis says:

      you spoke my heart with your reply and question.
      yes I have used Dr. Collins Restore toothpaste for several years and it is awesome product.
      I’m sure dentist in the USA desire Novmin product to be sold by medical prescription only( if at al) because it is totally awesome and cuts back on the need to frequent the ddst .
      note:Burt’s bees tooth paste list Novmin as it’s inactive ingredient which must be in order to get around FDA or GSK patient issues.
      Soon I feel the GSK Sensodyne mystery will be resolved here in the USA.
      But really feel it all boils down to greedy medical profession by prescription only=control.

  24. Peter Wray says:

    The only over-the-counter products available in the US would have had to have been previously manufactured and probably a few years old. Before GSK purchased NovaMin, it provided the materials to several small toothpaste makers and there may be some stray inventory still around, but GSK currently will not supply NovaMin to other companies.

  25. Cat Chew says:

    I did a little searching online and had no problem finding toothpaste with Novamin (and no flouride) for sale at drugstores and online outlets in the USA. I only bothered because I take all corporate blame-the-government claims with a block of salt these days.

  26. rrrcryst says:

    Just had my teeth cleaned in NC. Mentioned this article to the dentist. He gave me a prescription package of Sensodyne that has a high content of stannous flouride with NovaMin. Does the European and Canadian version also contain high levels of fluoride with the NovaMin?
    I would prefer less to no fluoride. Otherwise it is available in the US by prescription. The dentist said he had just gotten a case of it.

  27. RK Brow says:

    Great story, Peter- I look forward to the day when we in the US will join the rest of the civilized world and be able to buy toothpaste filled with ground-up glass ;-)

  28. Bob Lipetz says:

    Peter, thanks for the investigative reporting. Tooth enamel that is shallow and porous, becomes solid again after 10 days according to clinical studies. What part of “repair” does the FDA not understand?

  29. T.A. says:

    Very interesting product. I live in Canada and was curious if the NovaMin was missing here too.
    According to walmart.ca, our Canadian version contains NovaMin. If true, it may be easier to get that trying to source from Europe…

    http://www.walmart.ca/canada-estore/catalog/productdetailpagecontainer.jsp?skuId=10197829&utm_campaign=bazaarvoice&utm_medium=SearchVoice&utm_source=RatingsAndReviews&utm_content=Default

  30. S. J. Glass says:

    Peter, Fascinating saga and mystery. I’ll look for the real thing when I’m out of the country. Can’t wait to try it.

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