Medication Monitor

Generic Name (Trade Name—Company)
June 26, 2018

Desmopressin acetate

(Nocdurna—Ferring Pharmaceuticals)
First sublingual tablet approved to treat nocturia due to nocturnal polyuria

FDA approved desmopressin acetate as the first sublingual tablet for treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. The formulation of the sublingual tablet and sex-specific dosing was demonstrated to be effective in reducing nighttime trips to the bathroom in adults aged 18 years and older.

Nocturnal polyuria, a disease of the kidneys, is the most common underlying cause of nocturia, which can affect adults at every age. It occurs when a person has insufficient nocturnal vasopressin, causing an overproduction of urine in the kidneys at night. Unlike treatments that target the bladder or prostate, desmopressin acetate acts on receptors in the kidney to absorb more fluid and produce less urine during the night while patients sleep.

The product was approved with a boxed warning because it can cause hyponatremia. Severe hyponatremia can be life threatening, leading to seizures, coma, respiratory arrest, or death.

Desmopressin acetate will be available in the second half of 2018.