FDA approves noctiva nasal spray for nocturnal polyuria
Noctiva is the first drug approved to treat nocturnal polyuria in the United States, the FDA added. Noctiva, taken about 30 minutes before bed, is designed to increase absorption of water through the kidneys, decreasing urine production. Before prescribing Noctiva, health care providers should confirm overproduction of urine at night by collecting a 24-hour urine sample, the FDA recommended. They should also 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 two, 12-week clinical trials involving 1,045 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, the FDA said.
Noctiva should not be used by patients with symptomatic congestive heart failure or uncontrolled hypertension, the FDA added. 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 Milford, Pa.- based Renaissance Lakewood for Serenity Pharmaceuticals.