FDA Approves Crisaborole to Treat Atopic Dermatitis
ROCKVILLE, Md -- December 15, 2016 -- The US Food and Drug Administration (FDA) has approved crisaborole (Eucrisa) ointment to treat atopic dermatitis in patients aged 2 years and older.
Crisaborole, 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 crisaborole were established in 2 placebo-controlled trials with a total of 1,522 participants aged 2 to 79 years with mild to moderate atopic dermatitis. Overall, participants receiving crisaborole achieved greater response with clear or almost clear skin after 28 days of treatment.
Serious side effects of crisaborole include hypersensitivity reactions. The ointment should not be used in patients who have had a hypersensitivity reaction to crisaborole. The most common side effect of crisaborole is application site pain, including burning or stinging.
The FDA urges patients and healthcare professionals to report side effects involving crisaborole or other medicines to the FDA MedWatch program by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).
SOURCE: US Food and Drug Administration
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