FDA Approves Noctiva Nasal Spray for Nocturnal Polyuria

First agency-cleared treatment for this condition

The FDA has approved desmopressin acetate (Noctiva, Serenity Pharmaceuticals) nasal spray for adults who awaken at least two times per night to urinate because of nocturnal polyuria. Desmopressin nasal spray is the first FDA-cleared treatment for this condition.

Nocturia can be caused by a variety of conditions, including congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Before considering desmopressin nasal spray, health care providers should evaluate each patient for possible causes of his or her nocturia, and should optimize the treatment of underlying conditions that may be contributing to the night-time urination. Because desmopressin is approved only for adults with nocturia caused by nocturnal polyuria, health care providers should confirm the overproduction of urine at night with a 24-hour urine collection, if one has not been obtained previously. Health care providers should also be mindful of underlying conditions that can cause nocturia, but that make treatment with desmopressin unsafe, such as excessive drinking of fluids or symptomatic congestive heart failure.

Desmopressin nasal spray is used daily, approximately 30 minutes before going to bed. It works by increasing the absorption of water through the kidneys, which leads to less urine production.

The efficacy of desmopressin nasal spray was established in two 12-week, randomized, placebo-controlled studies in a total of 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Although these studies showed a small reduction in the average number of night-time urinations with desmopressin compared with placebo, more patients treated with desmopressin were able to at least halve their number of night-time urinations, and patients treated with desmopressin had more nights with one or fewer night-time urinations.

Desmopressin nasal spray was approved with a boxed warning and a medication guide because it can cause hyponatremia. Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death. Health care providers should make sure the patient’s sodium level is normal before starting treatment with desmopressin nasal spray, and should check patients’ sodium levels within one week and approximately one month after starting treatment and periodically thereafter.

Desmopressin nasal spray should not be used in patients at increased risk of severe hyponatremia, such as those with excessive fluid intake; those with illnesses that can cause fluid or electrolyte imbalances; certain patients with kidney damage; and using loop diuretics or glucocorticoids. In addition, desmopressin nasal spray should not be used in patients with symptomatic congestive heart failure or uncontrolled hypertension because fluid retention can worsen these underlying conditions. Further, the product is not recommended for the treatment of nocturia in pregnant women or for use in children.

In clinical trials, the most common adverse events associated with desmopressin nasal spray included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, high or increased blood pressure, back pain, nose bleeds, bronchitis, and dizziness.

Although other FDA-approved medications that contain desmopressin are available, none of those medications is approved for the treatment of patients with nocturia.

Source: FDA; March 3, 2017.