The Food and Drug Administration (FDA) has approved the first drug to be made available in the United States for nocturnal polyuria, a condition that can cause nocturia — when patients wake frequently in the night to urinate.
The agency has given a marketing authorisation for desmopressin acetate nasal spray — branded as Noctiva by Serenity Pharmaceuticals — for adults who wake at least twice nightly to urinate because of the over-production of urine.
Desmopressin works by increasing the absorption of water through the kidneys, which leads to less urine production.
The FDA based its decision on the results of two randomised, placebo-controlled trials involving 1,045 patients aged over 50 years who had nocturia caused by nocturnal polyuria. The results showed that the number of night time urinations was reduced in patients taking desmopressin acetate compared with those in the placebo group.
Nocturia can be caused by a variety of conditions, including congestive heart failure, poorly controlled diabetes mellitus or diseases of the bladder or prostate, as well as certain medications.
The FDA says that before deciding to prescribe the product, health professionals should confirm the cause of nocturia as nocturnal polyuria with a 24-hour urine collection.
It warns that the product is unsafe for patients with symptomatic congestive heart failure or uncontrolled hypertension. It should also be stopped temporarily in patients with nasal conditions such as colds or allergies; it is not recommend for treating nocturia in pregnant women.
The drug can also trigger hyponatraemia, low sodium levels in the blood, which if severe can be life threatening. As a result, the FDA is not recommending the nasal spray for use by patients at increased risk of severe hyponatraemia, which includes people with excessive fluid intake and patients already taking loop diuretics or glucocorticoids
Healthcare providers are advised to check a patient’s sodium levels before prescribing the nasal spray and to monitor levels at regular intervals if the product is prescribed.
In the UK, desmopressin nasal spray is already lisensed for the treatment of nocturia, but only for nocturia associated with multiple sclerosis where other treatments have failed.