FDA Approves New Prescription Ointment for Eczema

The US Food and Drug Administration today approved prescription-only Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.  The ointment is made by Palo Alto, California-based Anacor Pharmaceuticals, Inc., which was acquired by Pfizer this past summer.
 
“Today's approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis,” said Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research (CDER).
 
Eucrisa, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, although its specific mechanism of action in atopic dermatitis is not known.  
 
The safety and efficacy of Eucrisa were established in two placebo-controlled trials with a total of 1,522 participants ranging in age from two years of age to 79 years of age, with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin  after 28 days of treatment.

Serious side effects of Eucrisa include hypersensitivity reactions, according to FDA. In addition, Eucrisa should not be used in patients who have had a hypersensitivity reaction to Eucrisa's active ingredient, crisaborole.
 
The most common side effect of Eucrisa is application site pain, including burning or stinging, according to FDA's announcement.