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  • Mirvaso has been approved by the FDA.

    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.

    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.


    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.
    Get Rosacea News here - https://rosacea-support.org

  • #2
    What a great news

    Hi that's great news, I've been waiting this for a long long time, I wonder when it would be available in South America.

    I hope this can be the final solution to my persistent redness.


    Greetings from Ecuador

    Comment


    • #3
      Great news! I have been tracking the progress of Mirvaso for around 7 years! This is a timely boost, as my skin has been in very poor condition recently. Any ideas what countries it will be available in first?

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      • #4
        Does anyone know if this is only for permanent redness or will it help for redness that comes and goes?

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        • #5
          all aboard the hype train. Hopefully i can avoid any more v-beams now :P

          However from everything id read previously it indicated that if it were successful in the trial that earliest release would most likely be 1st quarter 2014, but they're stating it will be hopefully be in pharmacies in September 2013. Does that seem a little too hopeful?
          Last edited by maskielli; 26 August 2013, 11:12 PM.

          Comment


          • #6
            This sounds promising for someone whose only symptom is erythema. After no success with finacea or metrogel I have doubted any topical medication being effective, what makes this different?

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            • #7
              Originally posted by Redsox1112 View Post
              This sounds promising for someone whose only symptom is erythema. After no success with finacea or metrogel I have doubted any topical medication being effective, what makes this different?
              I cant remember the exact science but it works by acting on a receptor that when affected constricts the blood vessels, unlike oracea and metrogel which are more for paustules and pauples

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              • #8
                Nice, hopefully the UK follows soon.

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                • #9
                  Mirvaso

                  I have super-duper sensitive skin and cannot put anything on my face. What if I cannot use this either because it will burn????

                  Wendy

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                  • #10
                    Originally posted by cricket0117 View Post
                    Does anyone know if this is only for permanent redness or will it help for redness that comes and goes?
                    Officially it is for non-transient redness, i.e. not the sort of redness that comes and goes with a flush.
                    Get Rosacea News here - https://rosacea-support.org

                    Comment


                    • #11
                      Originally posted by maskielli View Post
                      However from everything id read previously it indicated that if it were successful in the trial that earliest release would most likely be 1st quarter 2014, but they're stating it will be hopefully be in pharmacies in September 2013. Does that seem a little too hopeful?
                      No it has been granted official approval and will be available in the US from next month.
                      Get Rosacea News here - https://rosacea-support.org

                      Comment


                      • #12
                        Originally posted by wendykay View Post
                        I have super-duper sensitive skin and cannot put anything on my face. What if I cannot use this either because it will burn????

                        Wendy
                        Hi Wendy,

                        That is a good question. The list of undesired side effects does include redness and burning as well as quite a few more. So there will sadly be some who cannot use Mirvaso.

                        Even though it would have been formulated with the lowest possible likelihood of irritating vehicle, the combination of the active and inactive ingredients will probably be still be tricky for some users.

                        More than 1% of trial participants had burning or redness so I would expect the population at large to be somewhere the same.

                        All the best,
                        dp.
                        Get Rosacea News here - https://rosacea-support.org

                        Comment


                        • #13
                          Originally posted by David Pascoe View Post
                          Officially it is for non-transient redness, i.e. not the sort of redness that comes and goes with a flush.
                          However, if Mirvaso acts by constricting blood vessels, I don't see that it wouldn't help with flushing at all. I really hope it will.

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                          • #14
                            Will there be any ways for sufferers outside of America to get Mirvaso next month? I am currently based in Australia. Thanks

                            Comment


                            • #15
                              Originally posted by Souris24 View Post
                              However, if Mirvaso acts by constricting blood vessels, I don't see that it wouldn't help with flushing at all. I really hope it will.
                              I've just seen that it's indicated for erythema. I haven't seen anything specifying whether it's for transient erythema (flushing) or non-transient erythema (fixed redness). Have I missed something? Regardless, I'd assume that it can help with both because of the mechanism.

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