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Otsuka Announces Acceptance of Tolvaptan Application

December 26, 2007

The FDA has accepted Otsuka Pharmaceutical Development & Commercialization’s new drug application for tolvaptan for the treatment of adults with worsening heart failure and treatment of hyponatremia.

Tolvaptan is a novel, investigational small molecule designed to be an antagonist of the vasopressin V2 receptor, which plays a role in the kidney’s regulation of fluid excretion.

Patients hospitalized for worsening heart failure often have excess body fluid, which is treated with diuretics. Tolvaptan is designed to promote aquaresis, the excretion of electrolyte-free water, according to Otsuka.

Data supporting the Japanese drugmaker’s application came from three Phase III trials.