Allergan announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) filing for oxymetazoline HCl cream 1.0%, an investigational topical prescription product for the treatment of persistent facial erythema (redness) associated with rosacea in adults.
Oxymetazoline is a sympathomimetic agonist that is selective for the α1A-adrenoceptor over other α1-adrenoceptors and nonselective for the α2-adrenoceptors. As such, it acts as a vasoconstrictor of the cutaneous microvasculature. The NDA submission for oxymetazoline HCl cream 1.0% was based on data collected from two Phase 3 pivotal clinical trials of a 29-day treatment duration and a one-year open label clinical trial. These studies enrolled male and female patients ≥ 18 years of age with moderate to severe persistent facial erythema associated with rosacea.
“While rosacea is a common chronic skin condition that affects more than 16 million people in the U.S. alone, there is a significant unmet need in effective, FDA-approved treatments for the condition,” said David Nicholson, chief R&D officer at Allergan. “The NDA filing of oxymetazoline speaks to our strong commitment to ongoing innovation of our medical dermatology portfolio, and we look forward to bringing a new treatment option to patients with rosacea.”