FDA approves Serenity’s Noctiva nasal spray for frequent night-time urination

The US Food and Drug Administration (FDA) has approved Noctiva (desmopressin acetate) nasal spray treatment for adults who wake up at least two times every night due to overproduction of urine, a condition known as nocturnal polyuria.

Renaissance Lakewood markets Noctiva for Serenity Pharmaceuticals.

FDA centre for drug evaluation and research division of bone, reproductive, and urologic products director Hylton Joffe said: "Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate.

"It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their healthcare provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them."

Conditions such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate may cause nocturia.

"Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate."

Healthcare providers are required to evaluate each patient for possible causes for this condition, as well as optimise the treatment of underlying conditions prior to considering Noctiva.

Noctiva increases the absorption of water through the kidneys and leads to less urine production.

The efficacy of this treatment was established as part of two 12-week, randomised, placebo-controlled trials conducted in 1,045 patients aged 50 and older.

It should not be used in patients at increased risk of severe hyponatremia or in patients with symptomatic congestive heart failure or uncontrolled hypertension.

Common side effects of Noctiva are nasal discomfort, cold symptoms (nasopharyngitis), nasal congestion, sneezing, high or increased blood pressure, back pain, nosebleeds, bronchitis and dizziness.