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Low Blood Sodium (Hyponatremia)

September 27, 2004

Yamanouchi Pharma America announced data from a clinical study of conivaptan, their vasopressin receptor antagonist for the treatment of dilutional hyponatremia, abnormally low concentrations of serum sodium due to increased body water. The results indicated that conivaptan was able to significantly increase serum sodium levels over the treatment course (the primary endpoint), reach these levels faster, and maintain these increases for a greater period of time (the secondary endpoints), versus placebo. This double-blind, multi-center study enrolled a total of 84 subjects suffering from symptomatic dilutional hyponatremia, including serum sodium levels of 115-130 mEq/L; subjects were treated with placebo or a regimen of 20 mg IV bolus of conivaptan followed by continuous infusion of one of two doses of the drug (40 mg/day or 80 mg/day) for 4 days. An NDA for conivaptan is currently being reviewed for approval by the FDA for the treatment of euvolemic and hypervolemic (dilutional) hyponatremia.