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Finacea Foam for Rosacea: FDA Approval

We have just received news that the FDA has approved a new product that targets Acne Rosacea (papulopustular). It contains 15% Azaelic Acid and is called Finacea Foam.

Here is the news transcript:

FDA Approves Bayer’s Finacea (azelaic acid) Foam, 15% for the Topical Treatment of the Inflammatory Papules and Pustules of Mild to Moderate Rosacea

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.

The product uses “foamix technology” from Foamix Pharmaceuticals, who also manufacture acne products. So it is the result of a joint venture between Bayer HealthCare and Foamix Pharmaceuticals.

Here are the active ingredients in Finacea Foam:

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.

Research Trials Were Promising

Here is some further information about Finacea Foam research and testing, from Skin and Allergy News.

Investigational Azelaic Acid Foam Quells Rosacea

FROM THE ANNUAL CONGRESS OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Medical Dermatology

By: BRUCE JANCIN, Skin & Allergy News Digital Network

LISBON – Physicians may soon have a new option for the treatment of papulopustular rosacea in the form of 15% azelaic acid foam.

The 15% foam is an extension of an existing product line which includes 15% azelaic acid gel as an approved topical therapy for mild to moderate rosacea, Dr. Blanka Havlickova explained at the annual congress of the European Academy of Dermatology and Venereology

Major Finding: In all, 43% of patients with papulopustular rosacea were rated as clear or as having minimal residual disease after 12 weeks of twice-daily, topical, 15% azelaic acid foam therapy.

Data Source: A double-blind, vehicle-controlled, randomized clinical trial of 401 patients with mild to moderate papulopustular rosacea who were randomized to 12 weeks of twice-daily, self-applied azelaic acid foam or vehicle.

Disclosures: The trial was funded by Intendis, which is developing the investigational agent.

 

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