FDA to Review Novel Topical Treatment for Atopic Dermatitis

FDA to Review Novel Topical Treatment for Atopic Dermatitis
FDA to Review Novel Topical Treatment for Atopic Dermatitis

Anacor announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for crisaborole 2% topical ointment for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

The NDA submission is based on positive results from two Phase 3 pivotal studies of crisaborole, both demonstrating statistical significance on all primary and secondary endpoints and consistent safety profile with previous studies. In addition, a long-term safety study for crisaborole also showed a tolerable safety profile consistent with that seen in the Phase 3 trials when used intermittently for up to 12 months.

RELATED: Melatonin May Improve Sleep in Children With Atopic Dermatitis

Crisaborole 2% topical ointment is an investigational, non-steroidal, topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor.

For more information visit Anacor.com.


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