Sansrosa delayed, sufferers make their own Brimonidine, BEWARE

Written by on January 19, 2011 in Galderma, Mirvaso Gel (Brimonidine 0.33%), Sansrosa with 12 Comments

The path from the laboratory for Sansrosa / COL-118 / CD07805/47 to a product that realises the promise of permanently reducing  a red face has been a long one.

We first heard about a product to become known as Sansrosa in Jan 2005 (also via a patent application in 2004).

Since then we have discovered that COL-118 was based on the active Brimonidine, as for example found in Alphagan-P from Allergan. Alphagan-P is used to treat the eye disease glaucoma.

brimonidine-alphagan-p

Galderma purchased Collagenex in February 2008. Ever since Galderma took over the products of Collagenex, the development of Sansrosa has only headed in one direction – backwards.

Faced with the prospect of having to wait several more years, or worse, that the product will never reach market, rosacea sufferers are going it alone and making their own formulations of Brimonidine. This task was made all the more easier by the publishing of the Sansrosa Ingredients.

Using Prescription Drug Off Label

It is estimated that 1 in 5 prescriptions in US is for a use not approved by the FDA.

The availability of what looks like the ingredients listing for Sansrosa, and the encouragement of some doctors to look for off-label treatments is all that some sufferers require to experiment for themselves.

Using prescription drugs off-label is not illegal, but their use is  not regulated by the FDA.

Here are some good reasons that you should be careful with off label drugs;

  • the bad reaction profile of the drug is not yet understood
  • the final dosage and frequency of treatment information is not known
  • you may not get insurance coverage for off-label usage
  • the full safety profile of a drug might not be know until several years after it has become available.

Encouragement by Doctors

Some doctors, looking for new options to treat their patients, may even suggest using existing treatments off-label. Here Dr. Webster is encouraging the use of topical brimonidine for cutaneous flushing.

Eye and Nasal Drugs Tame Rosacea

“For patients who are having a big problem with flushing [or] blushing, brimonidine [Alphagan] is a great drug. I use it routinely in my office,” Dr. Guy F. Webster said at the annual Hawaii Dermatology Seminar sponsored by the Skin Disease Education Foundation.

“I prescribe the 0.15% concentration and tell patients to put a couple of drops on their fingers, rub it onto their cheeks, see how long the effects last, and then use it accordingly. Typically, you can get through a workday with one application,” according to Dr. Webster of Jefferson Medical College, Philadelphia.

“The redness will go away for a few hours. It’s a pretty darn good drug and seemingly safe,” he commented.

About 15 years ago, there were reports of a big rebound effect following chronic use of nasal decongestants for their indicated purpose. That doesn’t seem to be a problem when oxymetazoline is applied to the skin, in Dr. Webster’s experience, and as also borne out in a published detailed case report by another dermatologist (Arch. Dermatol. 2007;143:1369-71).

Dr. Webster said he likes brimonidine because it’s his clinical impression that the drug not only relieves the flushing and redness of rosacea, but it also improves the fixed telangiectasias that are often present. Oxymetazoline does not have that effect.

Dr. Webster disclosed that he serves as a consultant to or has other financial relationships with a number of pharmaceutical companies, including Allergan Inc., which markets brimonidine.

So, there are clinical trials underway, the drug is reasonably well understood and some doctors are happy to prescribe Brimonidine for off-label use.

What could possibly go wrong?

Make Your Own Sansrosa

The user WrinkledClue at the Rosacea Forum has been trying Brimonidine under the supervision of their V Beam doctor.

Following are some extracts from the thread that details WrinkledClue’s trials with Brimonidine.

16th July 2010 10:30 PM

So far, the Brimonidine blanches out the wretched, chronically flushing diseased cheek, and keeps it pale for about 30 hours. One drop does that. It’s amazing. No dermatological irritation. No rebound flushing when I test it by stopping. I’m hoping this may be the help I need to get through menopause until my body quits inflicting these horrendous hormonal storms of change upon my damaged face.

16th July 2010 10:47 PM

Forgot to add that I asked Dr Masters about rebound flushing from Brimonidine. He said that nasal sprays cause rebound flushing when used in the nose. But his research indicates that Brimonidine, (a glaucoma drug, NOT a nasal spray), does NOT cause rebound flushing when used off label, topically, on a rosacea face. And that’s been my experience, too — no rebound effect. My rosacea breaks through everything I throw at it. If this stuff works well, it’ll be a godsend and I will highly recommend it.

19th July 2010 08:54 PM

This prescription eye drop for glaucoma called Brimonidine is really helping my wretched face. But I wanted to caution you NOT to put it directly on your face. It’s too strong. If you put it directly on your face, you’ll get a weird looking blanched-out circle that will get white within an hour or two and stay white for about 24 – 30 hours. Instead, you have to dilute the Brimonidine with a cream or moisturizer.
I put a dollop of Finacea in one palm, add a drop of water, and then add ONE DROP of Brimonidine to it. Stir with a finger and use that to paint half my face. Repeat on the other half of my face. Results after about one week of use, so far, are simply spectacular. And I’m hard to impress, with severe, progressive, debilitating flushes.

3rd August 2010 09:24 PM

The Brimonidine is still surpassing my expectations, and much of the permanent redness seems to be slowly leaving.
Also the Brimonidine seems to be slowly shrinking my spider veins and fixed telangectasias, yes. Good stuff, this new drug! -WC

Natalja posted some pictures from her Trial of Brimonidine at Vascular Rosacea Experiences of a Patient2

4th September 2010 12:47 PM (Melissa W)

Hi Natalja, I’m so sorry it caused rebound flushing for you. It did the same for me when I tried alphagan drops on my face in January 2009. When I tried this med though I used the .1 and then the .15% concentration so it was weaker than what you and WC and the others are using I believe. I don’t know why for some people it causes this reaction and for some it does not. The real question is why it isn’t causing the rebound for the others. Hopefully that is something the scientists are working on regarding this and perhaps that is why it is taking so long to come to market.

15th September 2010 10:22 PM

I do wonder why some folks are getting horrific rebound flushing. It certainly takes away from the wonder of this vasoconstrictor.
Let me repeat that I am using very small amounts of the Brimonidine. I literally add NO MORE THAN two or three drops from the tiny bottle to a rather large dollop of finacea; I add a few drops of water to that, I stir it all around with my finger, and then I use that to paint my entire face. It does seem like a little Brimonidine goes a very long way. I’ve noticed that Finacea is fabulous for my rosacea, I wonder if that’s making the difference? Some of the folks with rebound flushing are diluting the Brimonidine only with water and putting that directly on their face. That’s not what I do. Hoping for better health for all of us. –WC

19th November 2010 08:18 PM

Well, it’s taken four months, but now I too am getting rebound flushing from the Brimonidine. Maybe it took so long because I was using such a tiny amount? Brimonidine’s great when it’s working, but when it wears off, I’m redder than I was before putting it on. Which is awful. I’m so disappointed. I was heartbroken when so many others had bad results with it, and now I’m having bad results with it too.
Such a shame. More hope, dashed.

20th November 2010 03:35 AM

Hello Mistica, I quit the Brimonidine cold turkey. I used low dose hydrocortisone over-the-counter for two days to deal with the rebound flushing. Then I quit that, too. Now I’m all recovered from my Brimonidine experiment. Amazingly, I’m getting better, too– maybe the result of all the heavy V Beams I’ve had in the last year. Hoping for better health for all of us.

Wrapping Up The Trial

I put some questions to WC now that their trial of Brimonidine concluded.

Q: How did you go about finding out whether this treatment might be an option for you ?

A: I found out about Brimonidine when my dermatologist recommended it for me.

Q: Did using a treatment off label worry you?

A: Nothing about it worried me.   I figured I could always just stop if I had a bad reaction.

Q: Would you have any advice for others in your situation?

A: Use it sparingly.   I didn’t have rebound flushing for something like four months because I was only using a drop or two on my entire face.   People who had bad rebound flushing right away really used quite a lot of it.

Brimonidine Unsuitable ?

I hope that Galderma has solved the rebound problem with their final formulation of CD07805/47 because Brimonidine appears to be unsuitable topically on rosacea skin.

Many users are reporting strong rebound redness and flushing from Brimonidine. Please use Brimonidine, if at all, with care and under supervision of a doctor.

Worth The Risk ?

What do you think ? How experimental are you willing to be to find relief ? Is the absence of FDA approval enough to warn you off treatments like this ?

Alternatively, how do you decide for yourself where to draw the line when considering your own treatments ?

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

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12 Reader Comments

  1. Francis says:

    How can I get Brimonidine in Canada?

  2. Laura says:

    You can order it here, but be careful — I got rebound flushing after many months of using it. Such a shame!

    http://www.emedical.com.au/default.asp?pageID=56&itemID=15491&purchaseTypeID=1

  3. Laura says:

    Oops, I sent you the link for Finacea, which is available over the counter in some places. You asked for Brimonidine, not Finacea! My derm gave me a prescription for it, perhaps that’s an option for you?

  4. David Pascoe says:

    I think one of the good things about Alphagan P (Brimonidine Tartrate) only being available on prescription is that you have the opportunity to get the support of a physician when you think about trying something off-label.

    davidp.

    • Don says:

      I believe the alphagan actually caused my rosacea.

      I took alphagan for eyes that were red and irritated by pterygeum. I did not have rosacea when I started taking very infrequent drops. I developed redness and flushing and headaches around the same time I started on it but did not put 2 and 2 together until recently. I will be throwing out the remaining drops I have. I can’t believe the answer “why” was in front of me all the time.

  5. Francis says:

    Thank you very much for useful information!!

  6. Mark says:

    What about Oxymetazoline? Is this as effective as Brimonidine? Also are there reports of any rebound effects with this drug as I thought they were both similar.

  7. David Pascoe says:

    Hi Mark,

    There are reports that Oxymetazoline is good for 6 hours and safe for 3 months, so that is some cause for hope.

    I still have an open question about Rebound redness for Oxymetazoline. We will have to wait to see the reports about how V-101 performs during clinical trials.

    The good news is that the trials of Sansrosa and V-101 and friends will reveal more information about how safe and effective they will be if and when they get approved.

    davidp.

  8. Mark says:

    I tried the brimonidine drops too….Terrible rebound flushing.

    The ONLY way this drug will work is if they put it in a lipsomal/nanosomal formula that is time released.

    I Don’t recommend wasting your money on the drops.

  9. FBRed G says:

    We live in hope Sansrosa becomes available or more importantly works,it would be a godsend to all that suffer facial/neck flushing.So too any other med that is developed which I’m sure will be in the future,I’m being optimistic that a wonder cure will be developed for facial redness/flushing but sometimes I feel I wish I was living in 100 years in the future where I beleive nobody will have to suffer any associated problems with facial redness and the anxiety,mental distress issues it causes me and millions of other people due to such advance in meds by that time.
    Anyway I’m from the U.K and not heard of Brimonidine in it’s own form just briefly reading updates on Sansrosa but might now try the Brimonidine if obtainable here which I’m sure it is.It would be great if it worked rather than taking Clonidine everyday which helps so well for my flushing but hate taking drugs and don’t want to be consuming drugs all my life,I’m 35 nearly so don’t want the rest of my life on Clonidine.
    G

  10. George says:

    Its a shame that a drug that is so obviously floored is the most promising thing we have in the pipeline.

    People reporting these sorts of side effects is not a good sign that the end product will be suitable for every one to use. Even people involved in the sansorsa trials have reported rebound redness.

    Sorry guys, I usually hate people who are negative on these sites but its not looking too hopeful for sansrosa!!:-( It was the one I was most hopeful about not so long ago! George

  11. Mark says:

    Wait, this is not always the case. I have been using Brimonidine tartrate drops for 2 years on my face. I am 33, used to blush and flush and face swell up and stress out and could barely talk to my friends or wife. Took doxy, beta’s, clonidine, metrogel, etc. Now I only use BT. Off all other drugs. Brimonidine works, but it is very dose-dependent. I would argue that people reporting rebound flushing may not be using enough of it. I need at least 5-6 drops per cheek and 3 drops on my nose. Then I also use a few drops of water to rub in evenly. Apply a sunscreen over the top after it has dried almost all the way and go on with my day. It works amazing. Then around mid-day, wash my face and repeat the process. My face stays cool and pale (relatively) for the rest of the day. If I plan to drink or go out to dinner at night, I will repeat the wash and application a third time in one day. It takes more than 3 drops for a whole face. I have never had rebound redness, except when the BT wears off. But for that 4-6 hour window that I have it on, it is amazing! I worked at a medical research lab during my doctorate degree, and ordered BT in pure form from a manufacturer, mixed it in Afrin solution to make a stronger than 0.2% eyedrop formulation, and it is much more effective at higher %. Too bad that process cost so much or I would keep doing ordering it from that producer. But makes me hopeful of the more powerful version (0.5% Sansrosa) on the way. Good luck everyone!

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