Allergan announces FDA acceptance for potential treatment of facial erythema

14 Jun 2016

An investigational topical prescription product for the treatment of persistent facial erythema associated with rosacea in adults has been accepted by the Food and Drug Administration (FDA) for standard review.

Oxymetazoline HCl cream 1.0% is a sympathomimetic agonist that is selective for the a1A-adrenoceptor over other a1-adrenoceptors and non-selective for the a2-adrenoceptors.  

The New Drug Application (NDA) submission for oxymetazoline HCL cream 1.0% was based on data collected from two phase three 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 or over 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 US alone, there is a significant unmet need in effective, FDA-approved treatments for the condition," said David Nicholson, chief research and development 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," he said.


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