Astellas' Vaprisol receives FDA OK for treatment of electrolyte dilution

By Angela McDaniels

Seattle, Dec. 30 - Astellas Pharma U.S. Inc. said the Food and Drug Administration has approved Vaprisol (conivaptan hydrochloride injection) for the treatment of euvolemic hyponatremia in hospitalized patients.

The company said Vaprisol is the first drug specifically indicated for the treatment of euvolemic hyponatremia, a potentially life-threatening condition that occurs when the body's blood sodium level falls significantly below normal.

Vaprisol is administered intravenously and blocks the activity of arginine vasopressin antagonist, resulting in increased urine output without loss of valuable electrolytes such as sodium and potassium.

Euvolemic hyponatremia, which occurs when total body water increases with little increase in sodium, is most often associated with conditions such as cancer and hypothyroidism and the use of certain drugs such as some antidepressants, Astellas said.

The FDA also issued an approvable letter for Vaprisol as a treatment for hypervolemic hyponatremia, which is estimated to affect up to 4% of hospitalized patients in the United States each year. While many patients with hyponatremia have no symptoms, Astellas said severe cases are medical emergencies that can result in swelling of the brain, respiratory arrest and death.

"Currently available treatment options for hyponatremia, such as fluid restriction, diuretics and saline solution are inconsistent in their effects," Joseph Verbalis of Georgetown University Medical Center said in a company news release.

"Vaprisol will allow us to effectively correct the sodium-water balance in patients with euvolemic hyponatremia and will help us to better manage this common and potentially very serious condition."

In a randomized, double-blind, placebo-controlled study, intravenous administration of Vaprisol 40 mg/day for four days corrected the balance of sodium and water in hospitalized patients with mild to moderate euvolemic hyponatremia, the company said. The most common adverse events associated with Vaprisol were infusion site reactions, most of which were mild and did not lead to discontinuation of the drug.

Astellas Pharma U.S. Inc., with headquarters in Deerfield, Ill., is a subsidiary of pharmaceutical company Astellas Pharma Inc., based in Tokyo.

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