FDA OKs Azelaic Acid (Finacea) for Papulopustular Rosacea

Megan Brooks


July 31, 2015

The US Food and Drug Administration (FDA) has approved topical azelaic acid 15% foam (Finacea, Bayer Healthcare) for treatment of the inflammatory papules and pustules of mild to moderate rosacea, the company said today.

The approval is based on results from two pivotal vehicle-controlled 12-week clinical trials examining the efficacy and safety of twice-daily application of azelaic acid in more than 1300 individuals 19 to 92 years old with papulopustular rosacea.

In both trials, active treatment with azelaic acid foam led to a higher Investigator's Global Assessment success rate compared with vehicle control (32.1% vs 23.4% in trial 1 and 43.4% vs 32.5% in trial 2).

Both trials also demonstrated a greater reduction in the mean nominal change of inflammatory lesion count from baseline to end of treatment at week 12 with active treatment (−13.2 vs −10.3 in trial 1 and −13.3 vs −9.5 in trial 2).

The most common adverse reactions with azelaic acid (≥0.5%) are local application site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%), the company says.

They note that there have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, they advise that clinicians monitor these patients for early signs of hypopigmentation.

Azelaic acid may cause irritation of the eyes, and contact with the eyes, mouth, or other mucous membranes should be avoided.

The propellant in Finacea foam is flammable, and patients should be instructed to avoid fire, flame, and smoking during and immediately after application. The package should not be punctured or incinerated or exposed to heat.

Finacea will be available by prescription beginning in September 2015, the company says.


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