Allergan plc, a global pharmaceutical company, announced that the 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, has been accepted by the US Food and Drug Administration (FDA) for standard review. Allergan expects the Prescription Drug User Fee Act (PDUFA) date to be in the first half of 2017.
"While rosacea is a common chronic skin condition that affects more than 16 million people in the US alone, there is a significant unmet need in effective, FDA-approved treatments for the condition," said David Nicholson, chief R&D officer, 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."
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.
Rosacea is primarily an adult condition, with onset of symptoms generally occurring between the ages of 30-60 years of age. The diagnosis of rosacea is made based on the presence of one or more primary features centrally distributed on the face, including flushing, persistent redness, bumps and blemishes, and/or visible blood vessels. While the pathophysiology of rosacea remains largely unknown, it is thought to be a chronic, inflammatory and vascular disorder. Rosacea is not curable, and it generally requires long-term treatment to alleviate symptoms and delay or prevent disease progression. There are limited topical treatment options for persistent facial redness associated with rosacea available on the market today.