FDA Approves Drug for Treatment of Nocturnal Polyuria

The FDA has approved Noctiva (desmopressin acetate) for adults with nocturnal polyuria. The medication curbs urine production, thereby allowing people with  nocturnal polyuria  to sleep. It is administered by nasal spray, about 30 minutes before bed.

Noctiva is being marketed by Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC in Milford, PA.

Nocturia, having to get up at night to urinate, can be caused by a variety of illnesses, such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Nocturnal polyuria, however, is due to overproduction of urine at night.

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Two 12-week randomized placebo-controlled trials in 1,045 patients 50 and older showed Noctiva to be effective in reducing the number of night-time urinations. Compared to placebo, more patients treated with Noctiva were able to halve their previous number of night-time urinations, and had more nights with one or no night-time urinations.

The drug is approved only for nocturnal polyuria. This requires physicians to confirm the overproduction of urine with a 24-hour urine collection.

However, as Fei Wang, MSc, PharmD, BCPS, FASHP, TTS, Associate Clinical Professor at the University of Connecticut Department of Pharmacy Practice in Storrs, notes, “Desmopressin acetate is not a new drug. It is a synthetic analog of vasopressin (with antidiuretic effects) first approved in the 1970s for the treatment of diabetes insipidus, controlling bleeding in certain types of hemophilia, and to treat nocturnal enuresis in children over the age of 6 (nasal spray and IV formulations). In the treatment of diabetes insipidius, the intranasal dose is 5 mcg/day to 40 mcg/day 1 to 3 times per day.”

However, Wang added, “Noctiva may have an advantage in that it can be given once daily 30 minutes before going to bed and it is also indicated specifically for nocturnal polyuria secondary to a broad range of causes.”

Noctiva can cause hyponatremia, so it is approved with a boxed warning. Sodium levels must be checked again one week and one month after treatment begins, then periodically after. Noctiva should not be given to patients at increased risk of severe hyponatremia.

Noctiva should not be used in patients with congestive heart failure or uncontrolled hypertension. The drug should also not be used in patients with colds or allergies, and it is not recommended for pregnant women.

The most common side effects of Noctiva in clinical trials included nasal discomfort, nasopharyngitis, nasal congestion, sneezing, increased blood pressure, back pain, nose bleeds, bronchitis, and dizziness.