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FDA approves first drug to reduce frequent waking to urinate

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U.S. regulators Friday approved the first drug to reduce nighttime trips to the bathroom.

The treatment is a nasal spray intended for adults who wake up at least twice per night to urinate. The Food and Drug Administration said the spray, the so-called Noctiva, is not approved for the treatment of all the causes of frequent nighttime urination, so the doctor must determine the cause and best treatment for each person.

Noctiva is approved specifically for the a common condition caused by things such as chronic heart failure, poorly controlled diabetes, and bladder and prostate problems, as well as some medications.

The nasal spray is used daily, approximately 30 minutes before bedtime. It works by making the kidneys more water, thereby reducing the amount of urine.

Noctiva bears the FDA’s strongest warning, a so-called black box, because the drug can lead to dangerously low levels of sodium in the blood. Other side effects include colds, bronchitis, elevated blood pressure, dizziness, pain in the back and nose bleeds.

For the use of the spray, the patient should undergo testing to confirm that they are producing too much urine in the night.

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The treatment was tested for three months in about 1000 people from 50 years and older with the condition, called nocturnal polyuria. The half that used Noctiva had more nights with one or no trips to the bathroom, in comparison with the group who received a dummy and nasal spray, according to the FDA.

The active ingredient in Noctiva, desmopressin acetate, is included in a number of other drugs, including injected version for bleeding. The FDA said that the nasal spray version is the first approved treatment for frequent nighttime urination.

Noctiva was developed by partners Serenity Pharmaceuticals LLC of Milford, Pennsylvania, and Allergan NV, which has its head office in Dublin. Allergan could not immediately provide information about the drug of the price or when it will be available.

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