OraceaTreatment for Acne Rosacea
CollaGenex Pharmaceuticals' New Drug Application for Oracea Accepted for Review by FDA; Target PDUFA Date is May 30, 2006
NEWTOWN, Pa., October 3, 2005 - CollaGenex Pharmaceuticals, Inc. (NASDAQ:CGPI) announced today that the New Drug Application (NDA) for Oracea, the first orally administered, systemically delivered drug developed to treat rosacea, has been accepted for review by the U.S. Food and Drug Administration (FDA). The NDA for Oracea was submitted to the FDA on August 1, 2005. The Prescription Drug User Fee Act (PDUFA) target date for reviewing the submission is May 30, 2006.
The NDA submission was based primarily upon the safety and efficacy results of two Phase 3, double-blinded, placebo-controlled clinical trials for Oracea. These studies enrolled a total of 537 patients in 28 centers across the U.S. 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 (p less than 0.001 in each study). Side effects of the drug were similar to placebo. The data from these trials will be presented on October 21, 2005 at the 24th Anniversary Fall Clinical Dermatology Conference in Las Vegas, NV.
"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 W. Stewart, president and chief executive officer 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."
Approximately 13.6 million adults in the U.S. suffer from rosacea. It affects primarily the face and is characterized by the appearance of inflammatory lesions (papules, pustules and nodules), erythema (skin redness) and telangiectasia (spider veins). If allowed to progress to a moderate to severe condition, rosacea can cause itching, pain and thickening of the skin.
Posted: October 2005
- Oracea CollaGenex Pharmaceuticals, Inc. - Treatment for Rosacea - May 26, 2006
- CollaGenex Pharmaceuticals Files New Drug Application for Oracea - August 1, 2005