Anacor Submits NDA for Dermatitis Treatment

Anacor Pharmaceuticals has submitted an NDA for crisaborole topical ointment, 2%, a non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4), for treating mild-to-moderate atopic dermatitis in children and adults. According to the company, crisaborole is a novel boron-containing small molecule believed to inhibit PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis. The company reported the results of two Phase 3 studies 7/2015 in which crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. In October, Anacor also reported that its long-term safety study showed that crisaborole was well-tolerated and demonstrated a safety profile consistent with the profile in the Phase 3 studies when used intermittently for up to 12 months.