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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

ases as well as in its core R&D areas of central nervous system and oncology to address unmet medical needs. We are delighted that with the approval of SAMSCA, Otsuka will deliver a selective and corrective treatment for hyponatremia to patients and physicians in the United States."

The unique mechanism of action of SAMSCA selectively blocks the binding of vasopressin to the V2-receptors in the collecting duct of the kidney. If the V2-receptors are left unblocked, the binding of vasopressin with these receptors can cause water retention resulting in hyponatremia. By inhibiting the effects of vasopressin at the V2-receptor, SAMSCA increases the excretion of free water, while the excretion of sodium and other electrolytes is not directly affected (aquaresis).

"SAMSCA can help increase serum sodium concentrations without causing a significant change in urine excretion of electrolytes, which is good news for patients with hyponatremia," said Robert W. Schrier, M.D., Professor of Medicine, University of Colorado School of Medicine. "In addition, patients receiving SAMSCA can and should continue drinking fluids in response to thirst."

SAMSCA should be initiated and re-initiated in patients only in a hospital where their serum sodium can be monitored closely due to the risk of overly rapid correction of hyponatremia. Too rapid correction of hyponatremia (e.g., increase greater than 12 mEq/L/24 hours) can cause osmotic demyelination syndrome (ODS), resulting in dysarthria (difficulty speaking), mutism, dysphagia (trouble swallowing), lethargy, affective changes (mood changes), spastic quadraparesis (involuntary muscle weakness), seizures, coma and death. In susceptible patients, including those with severe malnutrition, alcoholism or advanced liver disease, slower rates of correction may be advisable. In controlled clinical trials in which SAMSCA was administered in titrated doses starting at 15 mg onc
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SOURCE Otsuka Pharmaceutical Co., Ltd.; Otsuka America Pharmaceutical, Inc.; Otsuka Pharmaceutical Development & Commercialization, Inc.
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