Cadence Pharmaceuticals Updates Omigard Clinical Timeline
Cadence Pharmaceuticals, Inc. (NASDAQ:CADX) announced today that it has revised the expected timing of its announcement of results for the CLIRS trial, the company's Phase III clinical trial of Omigard (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections.
Cadence is currently engaged in discussions with the U.S. Food and Drug Administration (FDA) regarding the statistical analysis plan for the CLIRS trial. These discussions, which are being conducted under a Special Protocol Assessment (SPA), must be completed prior to unblinding the data from the trial. As a result, Cadence has revised the expected timing of its announcement of results for the CLIRS trial from the fourth quarter of 2008 to the first quarter of 2009. If the trial is successful, Cadence continues to plan for submission of a New Drug Application (NDA) for Omigard in the second quarter of 2009.
About the CLIRS trial
The CLIRS trial, or Central Line Infection Reduction Study, is Cadence's confirmatory Phase III clinical trial of Omigard for the prevention of catheter-related infections. The CLIRS trial is a multi-center, randomized, evaluation committee-blinded study in patients whose medical condition requires a central venous catheter. The primary efficacy endpoint of the clinical trial is to evaluate whether Omigard is superior to 10% povidone-iodine in the prevention of local catheter-site infections. The CLIRS trial, which has completed enrollment of over 1,850 patients randomized to receive either Omigard or 10% povidone-iodine, is designed to have 80% power to detect significance at the 0.05 level. The CLIRS trial is being conducted under an SPA with the FDA, which has granted fast track status to the Omigard development program.
About Cadence Pharmaceuticals, Inc.
Cadence Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates principally for use in the hospital setting. The company currently has two Phase III product candidates in development, Acetavance (intravenous acetaminophen) for the treatment of acute pain and fever, and Omigard (omiganan pentahydrochloride 1% topical gel) for the prevention of catheter-related infections. For more information about Cadence's pipeline, visit http://www.cadencepharm.com/.