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news.Noven Pharmaceuticals has reported that a multi-center Phase III study of its developmental once-daily lithium carbonate product for bipolar disorder has failed to meet its primary endpoint with statistical significance.
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Approximately 240 subjects were randomized. The primary objectives of the four-week study were to determine the efficacy and safety of its lithium carbonate product (lithium QD) compared to placebo in the treatment of acute symptoms of mania in subjects with bipolar I disorder. The primary efficacy endpoint was change from baseline compared to placebo using the young mania rating scale (YMRS).
Florida-based Noven Pharmaceuticals acquired Lithium QD as part of its takeover of JDS Pharmaceuticals in August 2007.
Robert Strauss, president, CEO and chairman, said: “Both the Noven and JDS teams are very surprised and disappointed that the study did not achieve its primary endpoint. We are currently analyzing the data to determine why statistical efficacy was not achieved.”
Mr Strauss also said: “Based on our understanding of the efficacy of lithium and the delivery profile of this formulation, we continue to believe that Lithium QD has the potential to be a valuable once-daily option in the lithium therapy category. Accordingly, we remain committed to the continued development of this important product. We plan to complete our analysis of the data and consult with the FDA regarding appropriate next steps to advance development.”