Allergan Announces FDA Acceptance Of NDA Filing For Oxymetazoline HCI Cream

(RTTNews) - Allergan plc (AGN) announced that the New Drug Application 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, has been accepted by the U.S. Food and Drug Administration for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.

Oxymetazoline is a sympathomimetic agonist that is selective for the a1A-adrenoceptor over other a1-adrenoceptors and non-selective for the a2-adrenoceptors. As such, oxymetazoline is a potent 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 1-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.