(HealthDay News) — The FDA has approved Noctiva (desmopressin acetate) nasal spray to treat patients with nocturnal polyuria.
Noctiva is the first drug approved to treat nocturnal polyuria in the United States. Noctiva, taken about 30 minutes before bed, is designed to increase absorption of water through the kidneys, decreasing urine production. Before prescribing Noctiva, healthcare providers should confirm overproduction of urine at night by collecting a 24-hour urine sample, the FDA noted. Clinicians are also advised to make sure a patient’s habits, such as excessive consumption of fluids, may not be contributing to the problem.
The drug’s effectiveness was evaluated in 2, 12-week clinical trials involving 1045 patients aged 50 and older with nocturnal polyuria. The drug’s label warns of an elevated risk for hyponatremia, which, if severe, could be life threatening if not promptly treated.
Noctiva should not be used by patients with symptomatic congestive heart failure or uncontrolled hypertension, the FDA noted. It should also not be used by pregnant women or children. The drug’s most common side effects include nasal discomfort, nasal congestion, sneezing, an increase in blood pressure, back pain, nose bleed, bronchitis, and dizziness.
Noctiva is marketed by Renaissance Lakewood for Serenity Pharmaceuticals.
- FDA approves first treatment for frequent urination at night due to overproduction of urine. [press release] US Food & Drug Administration. March 3, 2017.