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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

ter degree in SAMSCA-treated patients compared to placebo-treated patients as early as 8 hours after the first dose, and the change was maintained for 30 days. The percentage of patients requiring fluid restriction (defined as less than 1L/day at any time during the treatment period) was also significantly less (p less than 0.0017) in the SAMSCA-treated group (30/215, 14 percent) as compared with the placebo-treated group (51/206, 25 percent).

In an open-label study (SALTWATER), 111 patients, 94 of whom were hyponatremic, who had previously been treated with either placebo or SAMSCA (and who had returned to standard of care for at least 7 days), were administered SAMSCA. Upon initiation of therapy, average serum sodium concentrations increased to approximately the same levels as observed for those patients previously treated with SAMSCA and were sustained for at least a year.

The safety of SAMSCA has been evaluated in more than 4,000 patients, approximately 650 of which had hyponatremia. Of these 650 patients, approximately 219 received SAMSCA for six months or more. In the two 30-day, double-blind, placebo-controlled trials, the most common adverse reactions (greater than or equal to 5 percent more frequently than in patients receiving placebo) observed in patients receiving SAMSCA (n equals 223, placebo n equals 220) were thirst (16 percent vs. 5 percent in placebo patients), dry mouth (13 percent vs. 4 percent), asthenia (9 percent vs. 4 percent), constipation (7 percent vs. 2 percent), pollakiuria or polyuria (11 percent vs. 3 percent), and hyperglycemia (6 percent vs. 1 percent). In these studies, 10 percent of SAMSCA patients discontinued therapy due to adverse reactions compared to 12 percent of placebo-treated patients.

About Hyponatremia

Hyponatremia, a common electrolyte disorder in hospitals, occurs in as many as 6 million people in the United States or 15-20 percent of hospitalized p
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SOURCE Otsuka Pharmaceutical Co., Ltd.; Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development & Commercialization, Inc.
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