A twice-daily formulation of Xibrom has already been approved by the FDA for the indication.
The Xibrom once-daily phase III clinical trials are expected to enroll approximately 350 patients under a common protocol, and are designed to investigate the safety, tolerability and efficacy of the new formulation of the drug.
Ista said that it believes that the clinical trials will be concluded in the fourth quarter of this year with preliminary results available in early 2007. Assuming timely completion and successful results of the phase III clinical studies, Ista intends to file a supplemental new drug application for the once-daily formulation of the drug in 2007.
“These phase III studies of a once-daily formulation are a natural extension of Ista's continued research with Xibrom,” stated Dr Vicente Anido, Jr., president and CEO of Ista Pharmaceuticals. “The trials we are now initiating are designed to demonstrate that once-daily application of our new proprietary formulation of Xibrom can further reduce the number of daily doses, potentially improving compliance while maintaining effectiveness.”