Sansrosa and Afrin Updates from Dr. Fowler & Dr. Webster

Skin and Allergy News is running an article dated this week based on some informal comments from Dr. Joseph F. Fowler Jr. and Dr. Guy W. Webster given recently at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation (SDEF).

These comments relate to two of the hottest topics in rosacea research at the moment, new products in development from Galderma and Allergan.

Maximize your resources for treating rosacea

By: BRUCE JANCIN, Skin & Allergy News Digital Network

04/05/13

MAUI, HAWAII – Within the next year or two, two promising new topical medications may join the roster of products for managing rosacea, according to Dr. Joseph F. Fowler Jr.

There are a number of very interesting points made in the article. Lets look at a few of them.

1. Galderma has submitted an application for FDA marketing approval of Sansrosa.

Dr. Fowler confirmed that Galderma has submitted an application for Food and Drug Administration marketing approval of Sansrosa / (CD07805/47 Topical Gel).

Brimonidine is further along in development;

Galderma has submitted an application for Food and Drug Administration marketing approval of the product.

This is great news and the first confirmation we have had of this fact.

It things go well it could be as little as 15 months before it becomes approved. Dr. Fowler suggested `around a year’ assuming that no problems arise.

2. Sansrosa and Oxymetazoline Both Work Well

Dr. Fowler is a position where he is able to comment on the effectiveness of these two new treatments, being involved directly with the development and trials by Galderma and Allergan.

“Having seen both of these drugs in studies, I think both are going to be effective,” said Dr. Fowler, of the University of Louisville (Ky.). “I have no idea if one will be more effective than the other, but I can tell you that both of them are probably going to be a lot better than anything else we have now for the erythema of rosacea,” he noted.

3. Dr. Webster encourages Off Label Treatment

Rosacea News quoted Dr. Webster in 2010 in his comments about off-label treatment of rosacea symptoms. Now 3 years later some more insight into his experience with the active molecules from these yet-to-be-approved treatments.

Dr. Guy W. Webster described his off-label experience in treating rosacea using oxymetazoline and brimonidine in their current formulations.

“These are two off-label products that really work,” he said. “I have rosacea patients who are such spectacular flushers that they can’t go outside in the wintertime, but many of them do great with one of these two off-label medicines.

Really does emphasize just how slow the drug approval process is that already 3 years have passed since we first heard these comments from Dr. Webster.

4. Alphagan-P Better than Afrin

When used as an off-label treatment, Alphagan-P works better than Afrin.

Of the two products, the brimonidine eye drops work better when applied to the skin, said Dr. Webster. In fact, the eye drops are so effective that patients require careful instruction in off-label use or they will end up with white streaking on a background of untreated redness that may last for 4-8 hours, he said.

Before embarking on your own experimentation, please note this article – Sansrosa delayed, sufferers make their own Brimonidine, BEWARE

5. Oxymetazoline Cream AGN-199201 better than Afrin

Alternatively, the version of Afrin that contains oxymetazoline can be sprayed on the cheeks for temporary relief of rosacea. However, the investigational cream formulation works better, Dr. Webster said.

Having been involved in the trials for Oxymetazoline V-101 / AGN-199201, Dr. Webster is in the unique position to be able to make this comment. For those who have tried Afrin and can’t use it because it is too harsh, the final cream formulation seems to be worth waiting for.

6. Metrogel 1% is “vastly superior” to 0.75% Metronidazole

Topical metronidazole 0.75% was the first the original concentration approved for rosacea, but the more recently approved 1% concentration is “vastly superior,” in Dr. Webster’s view.

“Unfortunately, a lot of our insurers make patients get the old generic form, which I find is like a placebo,” he noted.

So the 0.75% version of metronidazole is like a placebo treatment. I’m sure those involved in the double blind trials for the previous generation of Metrogel will beg to differ. If it was not provably better than placebo it would not have been approved originally as a treatment for rosacea.

I wonder if the difference in effectiveness is any way matches the difference in cost? It might be more effective, but for many that difference won’t match how much more it costs to get it from their pharmacy.

7. Metrogel and Finacea Don’t Work For Everyone

Dr. Webster said that some of his patients respond to azelaic acid – the other FDA-approved topical drug – but not to metronidazole, and vice versa.

This confirms that if you do not see a benefit first up from using Metrogel or Finacea, it is worth trying the other one as a second option.

Disclaimers

Dr. Webster serves as a consultant to half a dozen pharmaceutical companies, including Galderma and Allergan, which are developing brimonidine gel and oxymetazoline cream, respectively, as rosacea drugs.

Dr. Fowler is a consultant to multiple pharmaceutical companies, including Galderma, and is a research investigator for multiple companies including Galderma and Allergan.

Note also that SDEF who sponsored the talk is also owned by the parent company of Skin and Allergy News.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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9 Reader Comments

  1. Polly Waring says:

    I’ve been told by my dermatologist that the only thing that would improve my terrible case of Roseacea is the use of laser therapy. Yet insurance refuses to cover that because it is also used to treat skin for wrinkles. Is there any hope that that might change in the near future? What could be done to have it included as a verifiable treatment for this skin disease?

  2. sa19822 says:

    Thanks for all your hard work David. If no rebound flushing occurs this will change all of our lives!

  3. George says:

    Dr Webster talks about off label use of brimonidine and says that it works well. Myself and and many other on these forums have tried this and it causes rebound redness.

    I hate people who are negative on these sites but we have to be realistic.
    How sansrosa going to differ from standard brimonidine and if this Doctor thinks the standard formulation works well what are we to expect from the real Sansrosa?

  4. David Pascoe says:

    Hi George,

    Yes I agree it is unstable ground for doctors to promote off label treatments too broadly.

    We do know the formulation of Sansrosa, via a patent application, and the trials have lead us to believe that rebound redness is not a significant problem.

    The large Phase 3 safety trials should also confirm the results in a much larger group.

    So I am hopeful that it won’t be a problem, but whether it works for everyone all the time, we just won’t know yet.

    regards,
    dp.

  5. Dukecity says:

    So Sansrosa will hopefully be available by Summer 2014, yippie!!!

  6. Andy says:

    Looking forward to Sanrosa and testing it, going to remain sceptical until a few months of testing it. Fortunately my skin is in great condition at the moment with just a few redness flare ups.. Does that time frame apply to uk/Eu and the rest of the world

  7. David Pascoe says:

    The UK and EU approvals are independent of the FDA, so will have their own timeframes. They will take the trial data into account, but I don’t think you can make any assumptions on how quickly approval outside the US will take.

    It will also depend on how keen Galderma is to have it available in which countries after the US. They have been conducting Phase 3 trials in several EU countries so it seems that they do have a high level of interest in the EU, which is good news.

  8. Henrik says:

    Hi David, I, like most rosacea sufferers, have been following the progress of Sansrosa with great interest. I have recently relocated to Western Australia from the UK. Are you aware of any upcoming trials in Australia? Also, how long after FDA approval do you think it would be available in Australia? Thank you.

  9. David Pascoe says:

    Hi Henrik,

    Nothing has been published about trials in Australia.

    A “new” drug like Sansrosa will need a fresh approval process in Australia so we can’t say anything about how long it will take to be available here.

    Firstly, it will require Galderma to be interested enough in the Australian market to pursue approval. I can’t see it being high on their list, especially when you compare how much bigger the EU market is.

    For comparison, we have seen trials in Europe and Russia for Sansrosa.

    One more thing to consider about Australia is how much they hope to sell it for. If it is a substantial amount (and why wouldn’t they want this ?) then they will want to have it listed on the PBS. This takes some doing, they need to show that it outperforms everything else on the market and is really worth the benefit of the taxpayer subsidising it on a country basis.

    The other choice would be to try to sell it at the marketing price and hope private health insurances covers it in numbers.

    So I’m a bit pessimistic about how long it will take to be available here, but I’m sure there will be many that will be happy when I’m proven wrong …

    dp.

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