Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.
"The submission of the NDA for crisaborole topical ointment, 2% represents an important milestone for our atopic dermatitis development program, as we continue to leverage our boron chemistry platform to pursue innovative new therapies," said Paul L. Berns, Chairman and Chief Executive Officer of Anacor. "We believe there is a significant unmet medical need for a novel non-steroidal topical anti-inflammatory treatment option for the patients who are suffering with mild-to-moderate atopic dermatitis and we look forward to working with the FDA during its review of the crisaborole NDA."
In July 2015, Anacor announced the positive top-line results from its two Phase 3 pivotal studies of crisaborole. In each of the two Phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. In October 2015, Anacor announced the top-line results from its long-term safety study, in which crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months.
