Mirvaso

8/26/2013
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 FDA approval of Mirvaso provides a first-in-class therapy for facial redness of rosacea that we are proud to add to our existing rosacea portfolio, which includes Oracea® and MetroGel® 1% pump”

“Facial redness is the most common symptom of rosacea, but until now, physicians have been without prescription treatment options to specifically address this patient need,” said Mark Jackson, M.D., Clinical Professor of Medicine at the University of Louisville, dermatologist and a principal investigator for the phase 3 studies of Mirvaso. “The FDA approval of Mirvaso marks a turning point in rosacea treatment: we are now able to provide patients who deal with the daily frustrations caused by the redness of rosacea with an effective therapy.”

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.

“The FDA approval of Mirvaso provides a first-in-class therapy for facial redness of rosacea that we are proud to add to our existing rosacea portfolio, which includes Oracea® and MetroGel® 1% pump,” said François Fournier, President of North American Operations, Galderma Laboratories. “This milestone exemplifies Galderma’s continued, two-decade-long commitment to R&D to address the unmet needs of rosacea patients and clinicians.”

Mirvaso is safe and well-tolerated. In controlled clinical trials the most common adverse reactions (incidence ≥ 1%) included erythema, flushing, skin burning sensation, and contact dermatitis. In the long-term study, the most common adverse events (≥ 4% of subjects) included flushing (10%), erythema (8%), rosacea (5%), nasopharyngitis (5%), skin burning sensation (4%), increased intraocular pressure (4%), and headache (4%)

 

Yes, but the question is, who will sell it? Still not enough drugs over next few years to maintain your current over-manned sales force.

 

The real question is how long will mc companies cover what amounts to an aesthetic treatment. All it does is take the red away, it DOES NOT TREAT the rosacea. I give it a year, the spoty coverage and cash paying patients.

 

re mirvaso not treating rosacea, and being merely a cosmetic treatment.

define terms please.

finacea, metrogel, doxycycline (oracea) only address the appearance of rosacea, they do not cure it. there is no cure, and nobody agrees on the cause. therefore, I guess all the treatments are merely cosmetic. laser treatments are purely cosmetic, never mind that they can put rosacea essentially into remission for a period of time, because they dismantle the overactive vasculature. which is what mirvaso will do, for up to 12 hours at a time............sooooo


and by the way.
impotence is purely a cosmetic issue

signed,
a person afflicted with a purely cosmetically disfigured face due to rosacea

 

This gem of a product will be owned by Valeant within 6 months.

 

Guys... I work for another Derm, company. One of my docs just gave me some samples of Mervaso.

HOLY SHIT!!!!! This stuff is great!!!!! The older I get, the redder I became, especially after boozing. Mirvaso stops it cold. Even the solar letigenes on my cheeks are fading. Who cares if it isn't a cure. It works.

I'm getting a script asap from my doc... with as many refills as possible. I hope you are all paid on TRx and not NRx because the refills will be thru the roof. Any of you on this team are going to clean up.

 

Sorry about the typos... "I work for another Derm company" not "Derm, company"

 

you can get it now but early reviews have been pointing that its not anywhere close to being as effective as the trials suggested. About 70% of people who have posted about using it so far have had severe rebound and stopped use.

 

Lot of people with rebound flush..

When it comes in EU ?

 

100% rebound rate on all real users reported online, takes an entire week for them to get back to normal. I think we truly just hit the iceberg.

 

Love this hard ass culture here.

Treat us as professional working adults please.

Strange concept for this leadership group.

 

What leadership group?

 

Wow! Check out some of the comments (below the reviews). Here are a couple of recent ones
http://rosacea-support.org/mirvaso-user-reviews.html

edutechgirl
October 23, 2013 at 10:25 PM

initially impressed. Was given the sample by my derm on 10/17/13. The apples of my cheeks flush and somewhat across my cheekbones. Rosacea is a new diagnosis for me and he recommended mirvaso. I applied in the office and was told that full effects would take about 4 hours to achieve and last for about 12 hours. Applied at 3:30PM–noticed paler, decreased blushing within 20-30 min and no blushing within 2 hours even with a drink. This seemed to be the case on 10/18, 10/19–I didn’t use the product on 10/21 due to working out etc. Applied at 6AM on 10/22, within 2 hours both sides of my face (not just the apples/upper cheekbones like usual) was not only flushed, BUT the flushing got progressively worsenot just red, but practically burgundy. Thinking that perhaps I had not used enough or that I shouldn’t skip a day, I applied again the morning of 10/23–now people are asking me if I feel well, commenting on how “Terribly flushed” I look and asking me if I’m running a fever–one co-worker even commented that I look burgundy/purple—yeah, that never happened to me BEFORE putting this on my face–my face is on fire..worse than ever before..thought is was a miracle–apparently this is just a one-hit wonder–works the first time or two only? Glad I didn’t spend $$$ to get Rx filled since insurance won’t cover it.
Reply

Steve
October 24, 2013 at 12:06 AM

This seems to be a very consistent pattern. I too thought it was a miracle drug the first day or two. One week later, I still get random flushing and Benadryl lotion seems to be the only thing that will help. Somebody needs to wake up at the FDA.

 

A lot of the derms in the NE that I talk to are telling their patients to mix Mirvaso with other creams, lotions etc before applying to decrease rebound. They say patients are responding well to this. Anyone else hear anything about this?

 

WTF?? So now derms have to tell patients they need lotions to put out the fire on their face caused by Mirvaso? I can only imagine what the Rosacea message boards will say..."this stuff may work, but in order to help with the rebound flushing that everybody is getting, you need to use a lotion as well, and keep your fingers crossed that your face won't look worse than before."

 

That is a great message, I'm sure the geniuses at corporate will use that.

What a joke this drug and company have become. After seeing the article on Nestle and what they are willing to dump for underperformers...when do you all think we'll be bought by Valeant?

 

I hate this place, but all this slamming Mirvaso is just nonsense posted by other company's people.
my docs say one of ten patients (at most) are reporting any side-effects worth even mentioning. that's better than almost any product in any therapy.

All this rebound stuff is nonsense. It's a daily use product. You return to your original redness. It doesn't cure rosacea (nothing does), so if you engage in all your triggers while enjoying the effects of mirvaso, yes you might be redder than you were before that days treatment when it wears off AFTER 8 to 12 HOURS. That is NOT NOT NOT rebound!!!

Get a life - if you spent less time slamming us on here, you might have a better job than you do.

 

Are you kidding?!?!? Have you not talked to any of these patients, seen pictures, or talked with an md with experience with a patient that has had this happen?!???! You cannot be this naive/ignorant/stupid/lame/corporate and still employed... Honestly. Wait... It's Galderma... We promoted curly et al.

 

"You don't exist!"

- Galderma Management

 

You forgot to sign your post. let me help you out

-Signed, a finacea rep.