2 August 2017

First nocturnal polyuria drug approved

Drugs General practice

Australians with nocturnal polyuria now have access to desmopressin, (Nocdurna, Ferring Pharmaceuticals) the first treatment approved in this country for the condition.

The once-daily sublingual wafer is indicated for adults who have idiopathic nocturnal polyuria, confirmed by bladder diary with >33% of daily urine output passed overnight, who wake two or more times a  night to void and who have not responded to lifestyle measures.

Sydney urogynaecologist Dr Jenny King called the approval a “significant milestone” for the large number of Australians who had few treatments available, and called for greater awareness of the condition.

“Nocturia is a common urological cause of sleep disturbance across all ages,” Dr King said in a media release. “Nocturnal polyuria results from an abnormally large volume of urine production during sleep.”

Patients should take the wafer an hour before bedtime, with gender-specific recommendations of 25 micrograms a day for women and 50 micrograms a day for men.

The regulator approved the drug based on two phase-III trials which found improved quality of life, longer uninterrupted sleep periods and a reduced number of nocturnal voids. The most common side effects were nausea and headache.

Clinicians should monitor patients’ serum sodium at baseline, four to eight days, one month, and every three to six months after treatment initiation, as well as times when their medications are altered or their condition changes.