Home » Drug Information » Recently Approved Drugs » 2003
Medical Areas: Dermatology/Plastic Surgery
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Berlex Laboratories
Approval Status: January 2003
Treatment Area: Inflammatory papules and pustules of mild to moderate rosacea.
Finacea (azelaic acid 15%) is a topical gel indicated for the
treatment of inflammatory papules and pustules of mild to moderate
rosacea. The gel formulation of Finacea provides improved drug
penetration compared with the cream formulation.
Finacea is contraindicated in individuals with a history of
hypersensitivity to propylene glycol or any other component of the
formulation.
The approval of Finacea Gel, 15%, for the treatment of mild to
moderate papulopustular rosacea, was based on 2 clinical trials
comprising a total of 664 (333 active to 331 vehicle) subjects. The
primary efficacy endpoints were change from baseline in
inflammatory lesion counts and the treatment success, defined as a
score of clear or minimal with at least a 2-step reduction from
baseline. Scores were assessed on the Investigator’s Global
Assessment (IGA) scale.
Both multicenter, randomized, double blind, and
vehicle-controlled studies demonstrated a statistically significant
difference in reducing the number of inflammatory papules and
pustules associated with rosacea. Data showed that Finacea resulted
in a higher treatment score compared to its vehicle. Both trials
were 12-week studies with identical protocols.
Adverse events associated with the use of Finacea may include
(but are not limited to) the following:
- Burning and Stinging
- Pruritus
- Scaling/Dry Skin/Xerosis
- Edema
- Acne
- Seborrhea
- Photosensitivity
- Skin Disease
Finacea (azelaic acid) Gel, 15%, contains azelaic acid, a
naturally occurring saturated dicarboxylic acid. Azelaic acid is a
white, odorless crystalline solid that is poorly soluble in water,
but well soluble in alcohol. The mechanism by which azelaic acid
interferes with the pathogenic events in rosacea is unknown, but an
anti-inflammatory effect was found in vitro.
Azelaic acid is mainly excreted unchanged in the urine, but
undergoes some ß-oxidation to shorter chain dicarboxylic acids.
Del Rosso, J.Q. A status report on the medical
management of rosacea: focus on topical therapies. Cutis.
2002 Nov;70(5):271-5.
Rebora A. The management of rosacea. Am J
Clin Dermatol. 2002;3(7):489-96. Review.
