FDA Approves First Drug to Limit Frequent Waking to Urinate

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 a night to urinate. The Food and Drug Administration said the spray, called Noctiva, is not approved to treat all causes of frequent nighttime urination, so doctors must determine the cause and best treatment for each person.

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

The nasal spray is used daily about 30 minutes before bedtime. It works by making the kidneys absorb more water, which reduces the amount of urine.

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

Before using the spray, patients must undergo testing to confirm they produce excess urine at night.

The treatment was tested for three months in about 1,000 people 50 and older with the condition, called nocturnal polyuria. The half who used Noctiva had more nights with one or no trips to the bathroom, compared to the group that got a dummy nasal spray, according to the FDA.

The active ingredient in Noctiva, desmopressin acetate, is included in some other drugs, including an injected version for bleeding disorders. The FDA said 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 PLC, which is headquartered in Dublin. Allergan could not immediately provide information on the drug’s price or when it will be available.