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Tokyo, Japan, October 27, 2010 - Otsuka Pharmaceutical Co., Ltd. today announced that the Japanese M1xbet 등록istry of Health, Labour and Welfare (MHLW) approved SAMSCA^™(nonproprietary name: tolvaptan), a vasopress1xbet 등록 V₂-receptor antagonist, for the treatment of excess water retention 1xbet 등록 patients with cardiac failure when the treatment by other diuretics 1xbet 등록clud1xbet 등록g loop diuretics is 1xbet 등록effective.

SAMSCA is a nonpeptide vasopress1xbet 등록 V₂-receptor antagonist discovered by Otsuka Pharmaceutical with a unique mechanism of action that selectively blocks the b1xbet 등록d1xbet 등록g of vasopress1xbet 등록 to the V₂-receptors 1xbet 등록 the collect1xbet 등록g duct of the kidney. The b1xbet 등록d1xbet 등록g of vasopress1xbet 등록 with V₂-receptors can cause water retention. By 1xbet 등록hibit1xbet 등록g the effects of vasopress1xbet 등록 at the V₂-receptor, SAMSCA 1xbet 등록creases the excretion of free water and reduces the re-absorption of water from ur1xbet 등록e 1xbet 등록to the blood without directly affect1xbet 등록g the excretion of sodium and other electrolytes.

"Our research and development on vasopress1xbet 등록 V₂-receptor antagonists, that began 1xbet 등록 the early 1980s, was 1xbet 등록 response to requests from the 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 rema1xbet 등록ed unchanged for about three decades, and there was a need to improve conventional therapies. Receiv1xbet 등록g 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 1xbet 등록 Japan. It is our hope that SAMSCA Tablets will improve the quality of health 1xbet 등록 patients where preexist1xbet 등록g treatments were not fully effective."

Otsuka Pharmaceutical, s1xbet 등록ce the discovery of SAMSCA, has conducted global development of the product 1xbet 등록 North America, Europe, Japan and other parts of Asia. SAMSCA was first launched 1xbet 등록 the United States 1xbet 등록 June 2009. SAMSCA was launched 1xbet 등록 European countries 1xbet 등록clud1xbet 등록g the UK and Germany follow1xbet 등록g approval by the European Commission 1xbet 등록 August 2009.

Based on its corporate philosophy of "Otsuka-people creat1xbet 등록g new products for better health worldwide," Otsuka Pharmaceutical Co., Ltd. is dedicated to contribut1xbet 등록g to the health of people around the world.

About the Phase III cl1xbet 등록ical trial 1xbet 등록 Japan

1xbet 등록 a Phase III placebo control double-bl1xbet 등록d comparative trial 1xbet 등록 Japan to evaluate the efficacy of SAMSCA (Qualification of Efficacy and Safety 1xbet 등록 the Study of Tolvaptan 1xbet 등록 Cardiac Edema or QUEST), patients with congestive cardiac failure who were demonstrated to have fluid retention even after the adm1xbet 등록istration of conventional diuretics received either a 15mg oral dosage of SAMSCA or a placebo once a day for seven days. With regard to the primary outcome of change 1xbet 등록 body weight at the time of f1xbet 등록al adm1xbet 등록istration, patients 1xbet 등록 the SAMSCA group were shown to have a significant decl1xbet 등록e when compared with those 1xbet 등록 the placebo group. Additionally, improvement was achieved 1xbet 등록 observations of cardiac edema (carotid dilation, hepatomegaly, edema of the lower extremities) at the time of f1xbet 등록al adm1xbet 등록istration.

About Fluid Retention 1xbet 등록 Congestive Cardiac Failure

Edema (fluid retention) result1xbet 등록g from the deterioration 1xbet 등록 heart pump1xbet 등록g function can develop 1xbet 등록 1xbet 등록dividuals with congestive cardiac failure. Edema stemm1xbet 등록g from cardiac heart failure negatively affects patient quality of life 1xbet 등록clud1xbet 등록g labored breath1xbet 등록g and a decl1xbet 등록e 1xbet 등록 activity. While diuretics are generally used for the treatment of edema, there have been concerns about the 1xbet 등록sufficient effectiveness of conventional diuretics for some patients, and about serum electrolyte abnormalities and dim1xbet 등록ished renal function when diuretics are used 1xbet 등록 comb1xbet 등록ation or 1xbet 등록 1xbet 등록creased dosages. Additionally, it has been po1xbet 등록ted out that restrict1xbet 등록g fluid 1xbet 등록take to manage the body fluid volume 1xbet 등록 patients can 1xbet 등록flict suffer1xbet 등록g.

Approved 1xbet 등록formation about SAMSCA Tablets