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Positive Phase III Trial Results Announced for Actiza
The 12-week, double-blinded, active- and placebo-controlled trial included 1,026 patients at 18 centers across the U.S. The trial was designed to demonstrate that Actiza was not inferior to Clindagel(R) (clindamycin phosphate 1% topical gel) as measured by the primary endpoints of Investigator's Static Global Assessment (ISGA) and percent reduction in lesion counts (total, inflammatory and non-inflammatory) from Baseline to Week 12 (end of treatment). Success was defined as achieving non-inferiority to Clindagel for two out of three lesion counts and for ISGA. The trial results met or exceeded all of these requirements with a high level of statistical confidence. Additionally, Actiza was superior to placebo for all primary endpoints. Adverse events with Actiza were mild to moderate in nature and were related primarily to burning at the application site.
"The Connetics' team and our clinical investigators did an outstanding job enrolling and completing this trial on schedule, and we are delighted with the strength of the data," said Thomas G. Wiggans, President and Chief Executive Officer of Connetics. "Connetics is committed to building a strong franchise in acne, the leading category in the U.S. dermatology market. With Actiza, we look forward to launching what we believe will be the first of two products into this significant market."
"The results of the study are very exciting because Actiza will provide dermatologists with a novel product that combines an innovative vehicle with clindamycin, the most commonly prescribed topical antibiotic for the treatment of acne," said Alan Shalita, M.D., an Actiza study investigator, and Distinguished Teaching Professor and Chairman of the Department of Dermatology SUNY Downstate Medical Center.
According to the National Institute of Arthritis, Musculoskeletal and Skin Disorders (NIAMS), in the U.S. an estimated 17 million people are affected by acne, and an estimated 5.1 million people visited a physician for treatment during the 12 months ended July 2003. The prescription acne category is the largest segment of the dermatology market, and is estimated to be in excess of $1.5 billion annually in the U.S. Topical antibiotics, like clindamycin, are a major component of the prescription acne market and represent approximately $552 million in annual revenue. Clindamycin is one of the most widely prescribed medications for acne.
Source: Connetics Corporation