Noctiva Approved for Frequent Urination at Night
MONDAY, March 6, 2017 -- Noctiva nasal spray has been approved by the U.S. Food and Drug Administration to treat frequent urination at night due to excess urine production.
Nocturia, the medical term for getting up at night to urinate, can be caused by factors such as congestive heart failure, diabetes, certain medications or diseases of the bladder or prostate, the agency said in a news release.
Noctiva (desmopressin acetate) is approved for adults with nocturnal polyuria, an overproduction of urine at night. Noctiva is the first drug approved to treat the condition in the United States, the FDA added.
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 person's habits, such as excessive consumption of fluids, may not be contributing to the problem.
Noctiva, taken about 30 minutes before bed, is designed to increase absorption of water through the kidneys, decreasing urine production.
The drug's effectiveness was evaluated in two, 12-week clinical trials involving more than 1,000 people aged 50 and older with nocturnal polyuria. The drug's label warns of an elevated risk for low blood sodium, which if severe could be life threatening if not promptly treated, the FDA said. This means that people who use Noctiva should be checked regularly for low blood sodium, the agency added.
Noctiva should not be used by people with symptomatic congestive heart failure or uncontrolled high blood pressure, 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 Renaissance Lakewood, based in Milford, Penn.
Visit the FDA to learn more.
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Posted: March 2017