Jane S. Ricciuti, RPh, MS


March 19, 2003

In This Article

Dermatologic Agents

(azelaic acid) Gel, 15%

Manufacturer: Berlex Drug Development and Technology

Drug Approval Classification: Original New Drug Application (Approval Date: 12/24/02)

Indication: Finacea (azelaic acid) Gel, 15% is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Patients should be instructed to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages, and to use only very mild soaps or soapless cleansing lotion for facial cleansing.

Dosing: Finacea Gel is to be applied twice daily. Clinical studies have only evaluated Finacea in patients with mild to moderate rosacea for up to 12 weeks.

Clinical Summary: Azelaic acid gel, 15% was studied in two 12-week multicenter, randomized, double-blind, vehicle-controlled clinical trials in which a total of 664 patients with mild to moderate papulopustular rosacea were studied. The primary end points were defined as the change in baseline in inflammatory lesion counts and success defined as a score of clear or minimal with at least a 2-step reduction on the Investigator's Global Assessment (IGA) score.

Patients treated with Finacea experienced a 50% to 57.9% mean reduction in lesion count at the end of treatment compared with baseline and placebo vehicle reduction (38.2-39.9%). The percentage of patients with a score of "clear, minimal or mild" in the IGA at the end of treatment was 61% for Finacea and 40% for placebo.

Adverse Effects: Caution is advised to the patient to take Finacea for dermatologic use only. Contact with the eyes should be avoided.

The most common adverse effects include burning/stinging/tingling, pruritus, scaling/dry skin, and erythema/irritation.

Finacea is categorized as pregnancy category B -- there have been no well-controlled studies in pregnant women. Azelaic acid may pass into maternal milk, and caution is advised in nursing mothers.

Pharmacokinetics: The mean plasma concentration of azelaic acid after twice-daily topical application is 42 to 63.1 ng/mL. Azelaic acid is mainly excreted unchanged in the urine.

Finacea (azelaic acid) Gel, 15% Letter


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