FDA Accepts NDA for Allergan’s Oxymetazoline HCI Cream

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.”

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