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First Drug for Frequent Nighttime Urination Approved By FDA

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Nocturnal polyuria is caused by an overproduction of urine in the evening, which causes patients to wake two or more times per night.

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March 10, 2017 | by Sarah Hand, M.Sc.

Serenity Pharmaceuticals’ nasal spray, Noctiva, has been approved by the US Food and Drug Administration (FDA) to treat patients who experience frequent nighttime urination. The drug is the first FDA-approved treatment for the condition, known as nocturnal polyuria.

“Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate,” said Dr. Hylton V. Joffe, director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research. “It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”

Nocturnal polyuria is caused by an overproduction of urine in the evening, which causes patients to wake two or more times per night. Nocturia – the need to urinate multiple times through the night – can be caused by a number of other conditions aside from nocturnal polyuria, including congestive heart failure, diabetes and prostate disease.



According to Serenity Pharmaceuticals, 80 percent of patients who experience nocturia show overproduction of urine during the night associated with nocturnal polyuria. The condition is most common in people over the age of 50, and is estimated to affect tens of millions of adults.

Noctiva works by temporarily reducing urine production, thereby providing more uninterrupted sleep. Administered at night through a nasal spray, the drug is a vasopressin analog – or antidiuretic hormone – which causes the body to retain water.

Noctiva was approved based on the results of two placebo-controlled studies involving 1,045 patients. The average number of nighttime urinations in patients taking Noctiva was modestly reduced, compared to the placebo group.

The most positive outcome of these clinical trials was Noctiva’s ability to reduce most patients’ number of nighttime urinations by 50 percent. Patients taking the drug also showed an increase in the number of nights with one or fewer urinations.

The FDA’s approval of Noctiva does come with a caveat: the drug must be labelled with a boxed warning and prescribed using a medication guide. This decision was made based on the fact that some patients on the drug could experience dangerously low blood sodium levels – a condition known as hyponatremia.


Keywords: Drug Approval, FDA, Boxed Warning


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