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FDA Approves SAMSCA(TM) (tolvaptan), the First and Only Oral Vasopressin Antagonist to Treat Patients With Clinically Significant Hypervolemic and Euvolemic Hyponatremia
Date:5/21/2009

Once-Daily SAMSCA Increases Serum Sodium Levels Through Increase in Free Water Clearance

TOKYO and PRINCETON, N.J., May 21 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) announced today that the U.S. Food and Drug Administration (FDA) has approved SAMSCA(TM) (tolvaptan) as the only oral selective vasopressin antagonist for the treatment of patients with clinically significant hypervolemic and euvolemic hyponatremia (serum sodium less than 125 mEq/L, or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction) including patients with heart failure, cirrhosis, and the syndrome of inappropriate anti-diuretic hormone (SIADH). Patients requiring urgent treatment to raise serum sodium to prevent or to treat serious neurological deficits should not be treated with SAMSCA. Additionally, it has not been established that raising serum sodium with SAMSCA provides a symptomatic benefit to patients. SAMSCA, an oral vasopressin V2-receptor antagonist, will be commercialized in the United States by Otsuka America Pharmaceutical, Inc. (OAPI).

Once-daily SAMSCA has been shown to significantly raise serum sodium concentrations in as early as 8 hours, and the change was maintained for 30 days. Exposure and response to SAMSCA are similar in patients with a creatinine clearance of 10-79 mL/min and in patients without renal impairment; thus no dosage adjustment is necessary. SAMSCA has not been evaluated in patients with creatinine clearance less than 10 mL/min or in patients undergoing dialysis.

"The approval of SAMSCA marks a significant milestone for Otsuka," said Taro Iwamoto, Ph.D., President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "Otsuka Pharmaceutical Co., Ltd. has continued its commitment to create innovative products for cardiovascular, respiratory, digestive and infectious dise
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SOURCE Otsuka Pharmaceutical Co., Ltd.; Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development & Commercialization, Inc.
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