Those familar with my teaching know that I get most excited when discussing acid base or electrolyte problems. Thus, this story immediately caught my eye.
FDA Approves Astellas’ VAPRISOL(R) For The Treatment Of Euvolemic Hyponatremia
First arginine vasopressin (AVP) antagonist approved for the management of potentially life-threatening sodium/water imbalance
DEERFIELD, Ill., Dec. 30 /PRNewswire/ — Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved VAPRISOL(R) (investigational name: YM087, generic name: conivaptan hydrochloride injection), an arginine vasopressin (AVP) antagonist for the intravenous treatment of euvolemic hyponatremia in hospitalized patients. VAPRISOL, discovered and developed by Astellas, 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. The FDA also issued an approvable letter for VAPRISOL as a treatment for hypervolemic hyponatremia. Astellas plans on working closely with the FDA to obtain an approval for VAPRISOL’s use in patients with hypervolemic hyponatremia.
Most euvolemic hyponatremia occurs when ADH levels increase – either secondary to physiologic release of ADH (although inappropriate to the serum osms), e.g. pain, stress, nausea, narcotics, or due to non-physiologic release (the Syndrome of Inappropriate ADH). Once once diagnoses and ADH related hyponatremia, treatment becomes quite complex.
“Currently available treatment options for hyponatremia, such as fluid restriction, diuretics and saline solution are inconsistent in their effects,” said Joseph Verbalis, M.D., Chair, Department of Medicine, Georgetown University Medical Center. “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.”
This new drug represents a welcome advance to our treatment portfolio. Hyponatremia can be life threatening – and a new treatment option is exciting.
As usual, it will take some time to learn how best to use this new treatment and to learn the risks (since all treatments have some risk).
