Eucrisa Approval History
Medically reviewed on 14 December, 2016 by J.Stewart BPharm
- FDA approved: Yes (First approved December 14th, 2016)
- Brand name: Eucrisa
- Generic name: crisaborole
- Dosage form: Topical Ointment
- Company: Pfizer Inc.
- Treatment for: Atopic Dermatitis
Eucrisa (crisaborole) is a novel, non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor indicated for the treatment of mild-to-moderate atopic dermatitis.The approval of Eucrisa was based the results of two large clinical trials (Trials 1 and 2) that treated 1,522 patients with mild to moderate atopic dermatitis. In both trials, patients were randomized to receive Eucrisa or vehicle (non-medicated ointment) twice daily for 28 days. Data showed Eucrisa to be an effective treatment that achieved statistically significant results, with a greater number of patients reporting clear or almost clear skin at the end of the trial period, with some achieving success as early as day eight.
Eucrisa is applied as a thin layer to the affected areas twice daily. Common side effects include pain at the application site, such as burning or stinging.
Development History and FDA Approval Process for Eucrisa
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