04-08-2009: Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Europe Ltd. (OPEL) announced that the European Commission has approved the Marketing Authorisation Application for the company’s oral once-daily medication Samsca™(tolvaptan), a selective V2-vasopressin receptor antagonist, for the treatment of hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in adults. Samsca is the first oral vasopressin receptor antagonist available in Europe.
Results from the SALT-1 and SALT-2 (Study of Ascending Levels of Tolvaptan in Hyponatraemia -1 and -2 ) trial programme showed that once-daily oral tolvaptan was effective in increasing serum sodium concentrations in patients with SIADH.
Samsca is a novel molecule designed to be an orally available antagonist of the vasopressin V2 receptor, which plays a role in the kidney’s regulation of fluid excretion. Samsca is designed to promote aquaresis, the excretion of electrolyte-free water.