FDA Approves Nasal Spray For Nocturnal Polyuria

The FDA has approved Noctiva (desmopressin acetate) nasal spray for the treatment of adults with frequent nighttime urination due to the overproduction of urine (nocturnal polyuria).

Noctiva should be taken daily, approximately 30 minutes before going to bed. The drug works by increasing the absorption of water through the kidneys, leading to less urine production. The FDA noted that clinicians should, before considering Noctiva, first evaluate patients for possible causes of nocturia, and optimize treatment of underlying conditions that may contribute to it.
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The efficacy of Noctiva was established in two 12-week, randomized, placebo-controlled trials including 1045 patients aged 50 years or older with nocturia due to nocturnal polyuria. While only small reductions were observed in the average number of nighttime urinations when comparing Noctiva with placebo, more participants taking Noctiva were able to halve their number of nighttime urinations and had more nights with one or fewer nighttime urinations than with placebo.

The drug has been approved with a boxed warning and Medication Guide because of its potential to cause hyponatremia. Noctiva should not be used in patients with symptomatic congestive heart failure or uncontrolled hypertension.

The most common side effects of Noctiva include nasal discomfort, cold symptoms, nasal congestion, sneezing, high or increased blood pressure, back pain, nose bleeds, bronchitis, and dizziness.

—Michael Potts

Reference:

FDA approves first treatment for frequent urination at night due to overproduction of urine [press release]. March 3, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm.