The Food and Drug Administration (FDA) has approved Noctiva (desmopressin acetate nasal spray; Serenity and Allergan) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Desmopressin, a synthetic analogue of vasopressin, is a selective agonist at V2 receptors on renal cells in the collecting ducts, increasing water re-absorption in the kidneys, and reducing urine production.
The approval was based on two 12-week, randomized, double-blind, placebo-controlled trials that included 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Patients were required to have a six-month history of at least two nocturic episodes/night, on average, and at least 13 documented nocturia episodes over six nights during screening. Each trial had two co-primary efficacy endpoints: (1) change in mean number of nocturic episodes per night from baseline during the 12-week treatment period, and (2) percentage of patients who achieved at least a 50% reduction from baseline in the mean number of nocturia episodes per night during the 12-week treatment period.
While the trials showed a small reduction in the average number of nocturic episodes/night from baseline with Noctiva (Trial 1: –1.5 for both doses; Trial 2: –1.5 for 1.66mcg dose; –1.4 for 0.83mcg dose) compared to placebo (Trial 1: –1.2; Trial 2: –1.1), more patients treated with Noctiva were able to at least halve their number of night-time urinations (47% and 49% with 1.66mcg; 35% and 41% with 0.83mcg compared to 27% and 29% with placebo), and patients treated with Noctiva had more nights with one or fewer night-time urinations.
Noctiva is being approved with a Boxed Warning and a Medication Guide because it can cause hyponatremia. Clinicians should ensure that serum sodium is normal before starting or resuming Noctiva. Serum sodium should be measured within seven days and approximately one month after starting therapy or increasing the dose, and periodically during treatment. Patients 65 years of age and older and those with increased risk of hyponatremia should be monitored more frequently. If hyponatremia occurs, Noctiva may need to be temporarily or permanently discontinued.
The most common side effects associated with Noctiva include nasal discomfort, nasopharyngitis, nasal congestion, sneezing, hypertension/BP increased, back pain, epistaxis, bronchitis, and dizziness.
Noctiva has not been studied in patients younger than 50 years of age and is not approved for all causes of night-time urination. While there are other FDA-approved drugs that also contain desmopressin, none of these medication are approved to treat nocturia.
Noctiva is supplied as a nasal spray in two strengths: 0.83mcg/0.1mL and 1.66mcg/0.1mL. Each bottle contains 30 effective doses in addition to the initial priming (5 actuations) which is equal to 30 days of medication when used as one spray once a day.
For more information visit FDA.gov.