FDA OKs Noctiva, First Treatment for Nocturnal Polyuria

Disclosures

March 03, 2017

The Food and Drug Administration (FDA) today approved desmopressin acetate nasal spray (Noctiva, Allergan, Serenity Pharmaceuticals), the first treatment for adults who wake up at least twice a night to urinate because they overproduce urine — a condition called nocturnal polyuria.

Awakening at night to urinate (nocturia) has many causes, such as congestive heart failure, poorly controlled diabetes mellitus, diseases of the bladder and prostate, and various medications. Accordingly, clinicians should evaluate each patient with nocturia for its possible sources and optimize the treatment of underlying conditions, the FDA states in a news release. In addition, clinicians should confirm excess urine production with a 24-hour urine collection.

Taken nightly before bedtime, desmopressin reduces urine production by increasing water absorption through the kidneys.

In two randomized clinical trials involving some 1000 patients aged 50 years or older with nocturnal polyuria, there was a small reduction in the average number of bathroom trips for patients on desmopressin therapy compared with those on placebo. More patients treated with desmopressin experienced at least half as many night-time urinations compared with those in the placebo group.

The label for desmopressin includes a boxed warning because the drug can cause low levels of serum sodium (hyponatremia). A severe case of hyponatremia can lead to seizures, coma, respiratory arrest, or death. Before starting patients on desmopressin, clinicians should check their sodium levels and make sure they are normal. The drug is contraindicated for children, pregnant women, patients with symptomatic congestive heart failure or uncontrolled hypertension, and patients taking loop diuretics or glucocorticoids.

Nasal discomfort, cold symptoms, nasal congestion, sneezing, high or increased blood pressure, back pain, and nose bleeds were among the most common adverse events observed in the drug's clinical trials.

An FDA advisory panel recommended agency approval of desmopressin for nocturnal polyuria in a 14-to-4 vote in October 2016.

More information on today's announcement is available on the FDA website.

Follow Robert Lowes on Twitter @LowesRobert

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