New Drug Application for Tolvaptan, Otsuka's Investigational Novel Oral Treatment for Worsening Heart Failure and Hyponatremia, Accepted by the U.S. Food and Drug Admi...( PRINCETON N.J. Dec. 21 /- Otsuka ...)

PRINCETON, N.J., Dec. 21 /PRNewswire/ -- Otsuka Pharmaceutical Development & Commercialization, Inc. announced today that the U.S. Food and Drug Administration has accepted a new drug application (NDA) for the company's investigational oral once-daily medication tolvaptan, a selective V2-vasopressin receptor antagonist, for two indications: treatment of adults with worsening heart failure and treatment of hyponatremia.(1) These indications are based on data from three phase 3 pivotal trials.(2)

OPDC was established in 2007 by Otsuka America, Inc. (OAI). OPDC is wholly owned by OAI, which is the holding company for Otsuka Pharmaceutical Co., Ltd. (OPC) interests in the U.S. OAI is wholly owned by OPC.

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. The majority of patients hospitalized for worsening heart failure have edema or excess body fluid, which is treated with diuretics to excrete the fluid. In contrast to diuretics, tolvaptan is designed to promote aquaresis, the excretion of electrolyte-free water. In clinical trials, the most common adverse reactions in patients with worsening heart failure (incidence greater than or equal to 5% in patients treated with tolvaptan and double the incidence of patients treated with placebo) were thirst, dry mouth and polyuria. In patients with hyponatremia, the most common adverse reactions in clinical trials (incidence greater than or equal to 5% in patients treated with tolvaptan and double the incidence of patients treated with placebo) were thirst, dry mouth, asthenia, constipation, pollakiuria and hyperglycemia. The most serious adverse events were cardiogenic shock (1.7% in patients receiving tolvaptan vs. 1.2% of patients receiving placebo), pulmonary embolism (1.3% in patients receiving tolvaptan vs. 0.8% for patients receiving placebo,) and gout (4.7% in patients rece
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