Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has accepted CollaGenex' new drug application for Oracea, the first orally administered, systemically delivered drug developed to treat rosacea.
Subscribe to our email newsletter
Approximately 13.6 million adults in the US suffer from rosacea. It affects primarily the face and is characterized by the appearance of inflammatory lesions.
The NDA submission was based primarily upon the safety and efficacy results of two phase III, double-blinded, placebo-controlled clinical trials for Oracea.
These studies enrolled a total of 537 patients in 28 centers across the US In the two studies, patients receiving Oracea experienced a 61% and 46% mean reduction in inflammatory lesions compared to 29% and 20%, respectively, in patients receiving placebo.
The differences were clinically and statistically highly significant. Side effects of the drug were similar to placebo.
“This is an important step in the regulatory process as we work to bring the first approved systemic treatment for rosacea to the marketplace,” commented Colin Stewart, president and CEO of CollaGenex. “While acceptance of the Oracea NDA submission does not ensure FDA approval, we believe that the strength of our clinical data demonstrating the safety and efficacy of Oracea will enable us to achieve this goal.”