FDA accepts NDA for Otsuka's tolvaptan

Japanese drugmaker Otsuka says that the US Food and Drug Administration has accepted a New Drug Application for its investigational once-daily oral medication, tolvaptan, seeking approval for two indications - treatment of adults with worsening heart failure and treatment of hyponatremia - based on data from three Phase III pivotal trials, the firm noted.

The agent is a novel, investigational small-molecule 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, Otsuka noted.

In clinical trials, the most common adverse reactions in patients on the drug with worsening heart failure were thirst, dry mouth and polyuria. In those 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 in those given placebo) were thirst, dry mouth, asthenia, constipation, pollakiuria and hyperglycemia.