Researchers Develop Effective New Atopic Dermatitis Skin Cream

Anacor Pharmaceuticals recently announced favorable results from two phase 3 pivotal studies for Crisaborole Topical Ointment, 2% (previously AN2728), a non-steroidal topical anti-inflammatory PDE-4 inhibitor for treating children and adults suffering from mild-to-moderate atopic dermatitis.

More than 750 patients were included in both pivotal studies, with the patients randomized to either receive crisaborole or placebo twice daily for 28 days. Both primary and secondary endpoints were successfully met on day 29.

The only main adverse events reported were application site pain and upper respiratory tract infections.

With nearly 18 — 25 million people in the US afflicted with the condition, many often try various treatments to no avail.

Prolonged use of topical corticosteroids (broad anti-inflammatories), currently the most commonly prescribed treatment for atopic dermatitis, could trigger local side effects including skin thinning, acne, stretch marks, and HPA axis suppression.

Currently, the sole non-steroidal topical therapies approved in the US to treat atopic dermatitis are calcineurin inhibitors, which have a “boxed warning” on their labels signaling possible risk for cancer.

Lawrence Eichenfield, MD, Chief of Pediatric Adolescent Dermatology, Ray Children’s Hospital, San Diego, CA, remarked in a news release, “I’m impressed with the performance of crisaborole on the primary and secondary endpoints in these Phase 3 pivotal studies. Crisaborole represents an innovative non-steroidal topical anti-inflammatory and, if approved, has the potential to offer physicians and patients new, important therapeutic choice for treating mild-to-moderate atopic dermatitis.”

Anacor is slated to submit the New Drug Application for crisaborole to the FDAduring the first half of 1016.