Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves Finacea Foam, 15%
Rosacea drug treats inflammatory papules and pustules
Indications: Azelaic acid (Finacea Foam), 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
Dosage and administration:
• Apply a thin layer twice daily (morning and evening) to the entire facial area
• Cosmetics may be applied after application has dried
• Not for oral, ophthalmic or intravaginal use
Mechanism of action: The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
Efficacy and safety: Efficacy and safety were evaluated in two multicenter, randomized, double-blind, vehicle-controlled, 12-week trials in subjects with papulopustular rosacea. In both trials it was superior to its vehicle in reducing the number of inflammatory papules and pustules.
Side Effects/Risks: In clinical studies, the most frequently observed adverse reactions included local site pain (6.2%), pruritus (2.5%) dryness (0.7%) and erythema (0.7%). There have been isolated reports of hypopigmentation after use. Therefore, monitor patients with dark complexion for signs of hypopigmentation.
Source: Highlights of Prescribing Information: Finacea Foam, 15% (azelaic acid). https://labeling.bayerhealthcare.com/html/products/pi/Finacea_Foam_PI.pdf. Accessed August 2, 2015.