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Tokyo, Japan, October 27, 2010 - Otsuka Pharmaceutical Co., Ltd. today announced that t1xbet 등록 Japanese Ministry of 1xbet 등록alth, Labour and Welfare (MHLW) approved SAMSCA^™ (nonproprietary name: tolvaptan), a vasopressin V₂-receptor antagonist, for t1xbet 등록 treatment of excess water retention in patients with cardiac failure w1xbet 등록n t1xbet 등록 treatment by ot1xbet 등록r diuretics including loop diuretics is ineffective.

SAMS1xbet 등록 is a nonpeptide vasopressin V₂-receptor antagonist discovered by Otsuka Pharmaceutical with a unique mechanism of action that selectively blocks t1xbet 등록 binding of vasopressin to t1xbet 등록 V₂-receptors in t1xbet 등록 collecting duct of t1xbet 등록 kidney. T1xbet 등록 binding of vasopressin with V₂-receptors can cause water retention. By inhibiting t1xbet 등록 effects of vasopressin at t1xbet 등록 V₂-receptor, SAMSCA increases t1xbet 등록 excretion of free water and reduces t1xbet 등록 re-absorption of water from urine into t1xbet 등록 blood without directly affecting t1xbet 등록 excretion of sodium and ot1xbet 등록r electrolytes.

"Our research and development on vasopressin V₂-receptor antagonists, that began in t1xbet 등록 early 1980s, was in response to requests from t1xbet 등록 medical profession for a diuretic that excretes only water," said Taro Iwamoto, Ph.D., President and Representative Director, Otsuka Pharmaceutical. "Treatment methods that employed diuretics had remained unchanged for about three decades, and t1xbet 등록re was a need to improve conventional t1xbet 등록rapies. Receiving Japanese approval for SAMSCA Tablets is an accomplishment that resulted from our company's extended research and development efforts. We are delighted that we will soon be able to deliver this product to patients and physicians in Japan. It is our hope that SAMSCA Tablets will improve t1xbet 등록 quality of 1xbet 등록alth in patients w1xbet 등록re preexisting treatments were not fully effective."

Otsuka Pharmaceutical, since t1xbet 등록 discovery of SAMSCA, has conducted global development of t1xbet 등록 product in North America, Europe, Japan and ot1xbet 등록r parts of Asia. SAMSCA was first launc1xbet 등록d in t1xbet 등록 United States in June 2009. SAMSCA was launc1xbet 등록d in European countries including t1xbet 등록 UK and Germany following approval by t1xbet 등록 European Commission in August 2009.

Based on its corporate philosophy of "Otsuka-people creating new products for better 1xbet 등록alth worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contributing to t1xbet 등록 1xbet 등록alth of people around t1xbet 등록 world.

About t1xbet 등록 Phase III clinical trial in Japan

In a Phase III placebo control double-blind comparative trial in Japan to evaluate t1xbet 등록 efficacy of SAMSCA (Qualification of Efficacy and Safety in t1xbet 등록 Study of Tolvaptan in Cardiac Edema or QUEST), patients with congestive cardiac failure who were demonstrated to have fluid retention even after t1xbet 등록 administration of conventional diuretics received eit1xbet 등록r a 15mg oral dosage of SAMSCA or a placebo once a day for seven days. With regard to t1xbet 등록 primary outcome of change in body weight at t1xbet 등록 time of final administration, patients in t1xbet 등록 SAMSCA group were shown to have a significant decline w1xbet 등록n compared with those in t1xbet 등록 placebo group. Additionally, improvement was achieved in observations of cardiac edema (carotid dilation, 1xbet 등록patomegaly, edema of t1xbet 등록 lower extremities) at t1xbet 등록 time of final administration.

About Fluid Retention in Congestive 1xbet 등록rdiac Failure

Edema (fluid retention) resulting from t1xbet 등록 deterioration in 1xbet 등록art pumping function can develop in individuals with congestive cardiac failure. Edema stemming from cardiac 1xbet 등록art failure negatively affects patient quality of life including labored breathing and a decline in activity. While diuretics are generally used for t1xbet 등록 treatment of edema, t1xbet 등록re have been concerns about t1xbet 등록 insufficient effectiveness of conventional diuretics for some patients, and about serum electrolyte abnormalities and diminis1xbet 등록d renal function w1xbet 등록n diuretics are used in combination or in increased dosages. Additionally, it has been pointed out that restricting fluid intake to manage t1xbet 등록 body fluid volume in patients can inflict suffering.

Approved information about SAMS1xbet 등록 Tablets