Mirvaso (Sansrosa, Brimonidine) Approved for Rosacea Redness

News today that Galderma has succeeded in gaining FDA Approval for Mirvaso – the brand name chosen for the product that during development was known as Sansrosa, CD07805/47 and Col-118.
mirvasao-logo
The Brimonidine Tartrate 0.33% Topical Gel is expected to be available as soon as next month.

Great news that approval has been granted after so many years of waiting for rosacea sufferers following the development of this product.

It has been a long road for rosacea sufferers who have been waiting for a treatment for the red face of rosacea.

Galderma Receives FDA Approval of Mirvaso: the First and Only FDA-Approved Topical Treatment Specifically Developed and Indicated for the Facial Erythema of Rosacea

Mirvaso Works Quickly and Lasts up to 12 Hours

FT. WORTH, Texas–(BUSINESS WIRE)–Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Mirvaso(brimonidine) topical gel, 0.33% for the topical treatment of the facial erythema (redness) of rosacea in adults 18 years of age or older. Applied once daily, Mirvaso works quickly to reduce the redness of rosacea and lasts up to 12 hours. Galderma expects Mirvaso to be available in pharmacies September 2013.

The approval of Mirvaso was based on data collected from more than 550 patients enrolled in two phase 3 clinical studies of one-month duration. The results from both studies showed that adults who used Mirvaso demonstrated significantly greater improvement in the facial redness of rosacea than vehicle gel. In addition, a long-term study in 276 subjects who used Mirvaso for up to 12-months was also conducted. Mirvaso is a topical gel that may work by constricting the dilated facial blood vessels to reduce the redness of rosacea. Mirvaso should be applied in a pea-sized amount, once daily to each of the five regions of the face: the forehead, chin, nose and each cheek.

Note the Safety Information

Important Safety Information – Mirvaso® Gel

Indication: Mirvaso® (brimonidine) topical gel, 0.33% is an alpha-2 adrenergic agonist indicated for the topical treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years of age or older.

Adverse Events: In clinical trials, the most common adverse reactions (≥1%) included erythema, flushing, skin-burning sensation and contact dermatitis.

Warnings/Precautions: Mirvaso gel should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, thromboangiitis obliterans, scleroderma, or Sjögren’s syndrome. Alpha-2 adrenergic agents can lower blood pressure. Mirvaso gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease. Serious adverse reactions following accidental ingestion of Mirvaso gel by children have been reported.

Keep Mirvaso gel out of reach of children. Not for oral, ophthalmic, or intravaginal use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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

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42 Reader Comments

  1. Tomato says:

    [****] yeah! 😀

  2. SA12432 says:

    Finally, its here!! Cant wait for honest reviews regarding rebound redness. If it works it will change my life and many others.

    • Brandi says:

      I have used it and it is truly a miracle cream! Unfortunately, it will only change the lives of rich people because a tiny little tube is $300. Well I had a sample from my dermatologist so at least I got to use it three times , which is better than nothing I guess)

    • David Pascoe says:

      Unfortunately rebound redness is an issue that I think many users are still grappling with – maybe even too many users are grappling with.

  3. Dani. says:

    Is there any word as to whether the Therapeutic Goods Administration is going to give approval for Mirvaso to hit the Australian market?

  4. David Pascoe says:

    There is no information available on when/if it will be released in Australia.

    So if one wants to speculate ….

    It is entirely up to Galderma to decide how to tackle the Australian market. They can decide to try to get it listed on the PBS or make it available unsubsidised. A lot will depend on how well they can show that it is novel and worth the Australian Government subsidising it. Perhaps there is an argument that because it is the only approved topical treatment for rosacea redness it should be listed on the PBS. That path would take in the years timeframe.

    For eg. see that Oracea and Metrogel 1% are not available in Australia, I suspect mostly because they are not significantly better than the already available alternatives so would never get on to the PBS.

    That all assumes it is a priority for Galderma. The European market is so much bigger and they do seem to be more advanced in their approval process for Europe so my guess is that Australia will be well behind Europe for the availability of Mirvaso.

  5. elsa says:

    In France?

  6. Looie says:

    Is this going to be available in the UK? I for one would be over the moon if i had the chance to try this treatment as redness is the only rosacea symptom I suffer from and so far antibiotics and other topicals have not helped my symptoms much.

  7. David Pascoe says:

    It will of course be available in the UK and it seems that the submission and approval plans are quite advanced for the UK and EU.

    Various rumours of first quarter 2014, but no one can know for sure as it requires the various approval agencies to actually complete their processes.

    One good thing though is that it does seem that the UK is the second highest priority for Galderma for this and indeed all their rosacea pipeline drugs.

  8. SA12432 says:

    Do you guys think that it will help blushing? I personally think it would because if the blood vessels are constricted how would it be possible to blush or flush.

  9. ashleigh says:

    Anyone on the forum tried the new topical yet for their rosacea? I continue to use oracea and vbeam laser to help my condition and also changes in diet.

  10. mark says:

    Just wanted to let you know, I finally got the prescription called in and am picking it up tomorrow. Without insurance it costs $290 for a 30 gram tube.

  11. Rob says:

    Getting mine tomorrow

  12. Rob says:

    Still waiting. Anyone else have results?

  13. steven says:

    So I got it – about a week ago – used it 4 days – looked great at first, then seemed to have some breakthrough redness before the 12 hours were up. Thought I would stop using it for a few days as I thought I might be developing tolerance to it. The day after I discontinued it my face has been flushed more than before I used it. So rebound redness seems to be potential problem – It certainly has been for me. I may keep the prescription on hand just to use on “special days” where I really do want to minimize flushing and redness, but am concerned about the rebound as just a few day’s use of it has resulted in quite a bit of it. I wonder how long it will take for my flushing to return to “baseline”….

  14. lewis says:

    is this a long term solotion or is there a limit to how long someone could use this?
    thank you.

  15. steven says:

    I would say it took about 5 days to get back to baseline – decided to try it again for a day and applied just a small amount to my most problem areas – left on for about 8 hours and washed off. I looked great for that period of time, and had no rebound. So it may work best for me to use it as a PRN thing but not daily. I am sure there are a lot of variables that factor into how a person responds to mirvaso. It really does work though and think it is worth a try. You will just have to see how your skin reacts.

    To answer Rob’s question, I would say I do not want to use it every day because after a few days it seemed to not work as well for me suggesting I was probably developing a tolerance to the medicine so I thought best to hold on it to let my skin settle down and then retry it after the flushing normalized. It is true that they state it is effective for a year in trials, but that was just not my experience. It DID work great for the first 2-3 days and again using it once after giving my skin a break for a few days.

    If you get mirvaso – you will probably be like me the first day I applied it – I stared at my face in the mirror all day amazed by how pale and “normal” my skin looked. It was quite amazing.

  16. lewis says:

    intreasting, I think ill wait another year to see if there are any found side effects after 2 years, besides im only 17 I don’t think my doc would let me have it:(

  17. Blushing says:

    Hello, thanks for sharing your expericene with mirvaso. I am really excited with it.

    Please!! I am from Spain. In a deep crisis. Someone can do me the favor to get me this mirvaso?? i am really desperate with this rosácea and flushing and blushing. My email blushinglife@gmail.com please, i am a serious person that need help.

  18. Erin says:

    My dermatologist *promised* me that Mirvosa didn’t have any rebound flushing, but after a week of use I suffered terrible rebound flushing after I washed it off in the evening…actually, the worst flushing I had in my entire life (36 years old, rosacea for 20 years). And, the flushing was across my entire face, not just the places where I usually get redness (chin, center of forehead, around nose). I decided to stop using it altogether because I was afraid the extreme flushing would cause permanent damage.

  19. Lauren says:

    Just got it and although it seemed to work to some degree, I had some unusual breakthrough flushing. After only 2 days of use, I woke up to a red face anywhere I had used it (which is almost never the case prior). I don’t have a permanent blushing problem but instead get it particularly in the afternoons, and now it seems that with Mirvaso it is a 24 hour phenom. I read here that it isn’t for those who have the flushing/blushing come and go, but my derm thought it would be good for me. I still feel tempted by the potential ‘miracle’ cure, but sitting here red-faced, I suspect I will let this go until there is a wider range of experience. Very disappointing after a lifetime of suffering.

  20. Layla says:

    Horrendous rebound flushing. Does anyone know if this rebound flushing is permanent ??

    • Erin says:

      My rebound flushing went away after about 5 days.

      • Lauren says:

        and mine is diminishing. Used a bit of hydrocortizone on it this morning and it appeared to calm. But since this came after 2 days of limited use, I think I am going to live without this particular miracle. It wasn’t a blush – it was crimson and angry. Not very helpful!

  21. Trina says:

    I tried a sample of Mirvaso. I thought I looked so pale after applying to my face, I thought I would wait and see if my husband noticed anything different when he got home from work. When he seen me without me telling him I used it, he said I looked sick. Then when I told him he said all he noticed was the dark circles under my eyes. I said thats because there isno redness in my face. It did last about 24 hours. Then by thenext evening I noticed I looked red all over my face and really red in my problem spot (cheeks). After reading other reviews, I assum it is rebound redness. Im worried about making my whole face worse. Not sure if I should get the script.

    • Anon says:

      Speaking as someone who got the script and had the EXACT same experience as you, a week after using it I am definitely not happy with it at all. I’m angry I wasted the money on it, 3 days later my face has still not calmed down.

      • Lauren says:

        While I understand that these type of forums attract people who have had bad experiences, it seems pretty clear that the rebound flush is not just a group of outliers but actually more the norm. This is pretty concerning. Does anyone have an idea how this is most effectively escalated? My rebound flush lasted about 2 days (after only 2 days of use) but still is really troubling. I now have an expensive prescription which I will likely never use. And more concerning is that this may create some deeper, long-lasting impact which we don’t yet understand.

  22. E. Blosser says:

    I currently use Metrogel and Finacea. Would I use all three products now?

  23. Sophie says:

    Anyone know when this is coming to the UK? And is there anyone who is actually getting on good with this gel ?

  24. I was really excited to find out about this product so I rushed to my dr to get a script. I used the coupon on the website and it cost me around $50. I applied it as soon as I got home and nothing. So I used it again the next day and still nothing. Bummer.

  25. joyce says:

    haw can you receive a sample of mirvaso

  26. Ivy Ellis says:

    Don’t do it!

  27. Michelle Noto says:

    I added Miravaso to my daily regimen of Noritate cream on a clean face (Neutragena Ulta Gentle liquid cleanser) at night. In the morning, on a clean face, I use Miravaso before moisturizer (Aveno Calming). I have been doing this for about 2 weeks and my rosacea, which was not severe, has gotten noticeably better. After years of trying all remedies, this has worked the best for me. I get a little flushed after application, but it subsides in about 15 minutes. There is no feeling associated with this. I would recommend this gel as an addition to a skin healing regimen. And, no, I am not a paid spokesperson for any of the items I mentioned. They work for me and I just wanted to pass on my experience because I know how hard it is to find relief.

  28. Jessica says:

    I got a sample from my derm and loved it. I got the bigger size and still love it. I use cerave

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