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News today that the FDA has approved the azelaic acid based Finacea Foam.
WHIPPANY, N.J., July 31, 2015 /PRNewswire/ — Bayer HealthCare today announced that the U.S. Food and Drug Administration (FDA) has approved Finacea (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.
The approval is based on results from two pivotal clinical trials examining the efficacy and safety of Finacea Foam compared to its foam vehicle (without the drug azelaic acid) in the topical treatment of papulopustular rosacea.
Papulopustular rosacea is a skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.
What is Finacea Foam?
Finacea Foam is the same active ingredient as Finacea- namely Azelaic Acid 15%, but is “suspended in an oil-in-water emulsion vehicle for topical administration”.
Finacea Foam Inactive Ingredients
benzoic acid, cetostearyl alcohol, dimethyl isosorbide, medium-chain triglycerides, methylcellulose, mono- and di-glycerides, polyoxyl 40 stearate, polysorbate 80, propylene glycol, purified water, sodium hydroxide, and xanthan gum.
Finacea Foam Prescribing Information
See this link for the full Finacea Foam Prescribing Information (PDF).
Finacea Foam is based on Foamix Technology
A press release from Foamix confirms that Finacea Foam is using foaming technology from Foamix Pharmaceuticals.
Foamix are also making a foam based minocycline topical for Acne.
FinaceaFoam was developed as part of a research and development collaboration between Foamix Pharmaceuticals Ltd. and Bayer HealthCare, utilizing Foamix’s proprietary foam technology platform. According to a license agreement between the two companies, Foamix is entitled to royalties and certain milestone payments upon commercialization of Finacea Foam.
“The approval of Finacea Foam is an important milestone for Foamix, as this is the first prescription product developed using our technology to be FDA approved for sale in the United States,” said Dov Tamarkin, Chief Executive Officer of Foamix Pharmaceuticals. “We are proud of the progress made in our partnership with Bayer, and pleased that this product will be available to help people living with mild to moderate papulopustular rosacea.”
User Reviews
What do you think about Finacea Foam? What works better – Finacea Foam or Finacea Gel? Please do let us know.
I have been waiting for this one to get approved.
I have had some initial success with azelaic acid cream in the past. It significantly reduced the redness on my type 1 rosacea. But at the same time it tingles/burns and after a while it became so irritating and I had to discontinue.
Hopefully perhaps the foam version will be less irritating.
It’s expensive and has a 2 month expiration date, it dries fast and clear, not as harsh as the cream as far as stinging. I only use it when needed so for the money it’s not good for me. I’ll use the cream.
I hated it! It burned so bad on my raw face and neck, that it felt like I rubbed Jalapeño peppers on it. I tried to stand it, but got it off of me and in the trash within 5 min. And for that 1 use I paid $110 and insurance pd $223
I have been using finacea foam for 2 weeks now. So far I am very pleased with this product. My Rosacea was so bad that some days I did not want to leave my house. The foam has really reduced the redness and evened my skin tone. My huge bumps are gone and I only get a tiny whitehead here and there. The texture of my skin feels much better and more smooth. I hope that with continued use my skin will go completely back to normal. My doctor told me since I have very sensitive skin to put a good moisturizer on first and then a little foam goes a long way! This is the only product that has helped my skin so far!
I have moderate rosacea. Triggers out the ears. It’s impossible to avoid all of them some of which include the weather. Metrogel made me look like my face had been gone over with a cheese grater and even my nose swelled horribly. My dermatologist recommended this. It has been amazing. It really burned and was stinging for maybe 45 minutes at first. and my face was red for a while. After about a week my face broke out. That only lasted a few days. I was only using it at night at first. After a few weeks the burning and stinging got much better and lasts now only about five minutes or so and is hardly noticeable. When it dries it leaves a really nice matte finish. My face has not been this clear in probably 25 years. Most days I only use it at night. I know it’s expensive but in the past I tried Retin-A or Renova which my insurance did not pay for at all. It would be nice if they made it in a smaller size so that someone could pay less and use it only once a day. You can use a moisturizer over it if you’d like and I use any of the LaRoche Posay Toleriane moisturizers except for the Ultra one which breaks me out. I would really recommend you try it and stick with it for several weeks. My experience is years and years of even trying to get a diagnosis, then various meds, trying to figure out all the triggers, etc etc. To finally have found something is just wonderful. I am actually getting compliments on my skin!