FDA Approves New Nasal Spray for Frequent Urination

The US Food and Drug Administration (FDA) has approved the first therapy for adults with frequent urination at night due to overproduction of urine.
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Noctiva (desmopressin acetate) nasal spray is suggested for adults who awaken at least 2 times per night to urinate due to nocturnal polyuria – overproduction of urine during the night. The nasal therapy helps reduce the number of times an individual awakens to urinate by increasing water absorption through the kidneys. It is the first FDA-approved treatment for this condition and should be taken approximately 30 minutes before going to bed nightly.

Nocturia can be caused by a variety of symptoms, such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Health care providers are instructed to confirm overproduction of urine at night with a 24-hour urine collection and to evaluate individuals for possible causes for nocturia in order to note conditions that make treatment with Noctiva unsafe, such as excessive drinking of fluids or symptomatic congestive heart failure.

Noctiva’s efficacy and safety were confirmed in separate 12-week, randomized, placebo-controlled trials involving 1045 patients ages 50 years or older with nocturia due to nocturnal polyuria. The trials showed a modest reduction in the average of night-time urinations with Noctiva compared to placebo, but more patients treated with Noctiva were able to at least halve their number of urinations. Patients treated with Noctiva also had more nights with one or fewer night-time urinations.

The most common side effects of Noctiva in clinical trials included nasal discomfort, cold symptoms (nasopharyngitis), nasal congestion, sneezing, high blood pressure, back pain, nose bleeds, bronchitis, and dizziness. Noctiva is not recommended for patients at risk of hyponatremia, those who have illnesses that can cause fluid or electrolyte imbalances, those with kidney damage, those using loop diuretics or glucocorticoids, those with symptomatic congestive heart failure or uncontrolled hypertension, and women who are pregnant.

“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 health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them,” said Hylton V Joffe, MD, MSc, director of the Division of Bone, Reproductive, and Urologic Products, FDA, in a press release (March 3, 2017). – Zachary Bessette