FDA Okays Drug for Frequent Nocturia
By medpagetoday.com
For the first time the FDA approved a treatment for frequent nighttime urination due to overproduction of urine.
The drug, desmopressin acetate (Noctiva), is delivered as a nasal spray and is approved for use only in adults who awaken two or more times nightly to urinate due to nocturnal polyuria. 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 agency said.
In a statement, Hylton V. Joffe, MD, MMSc, of the FDA's Center for Drug Evaluation and Research, said, "It is important to know that Noctiva is not approved for all causes of nighttime urination, so patients should discuss their symptoms with their healthcare provider who can determine the underlying cause of the nighttime urination and whether Noctiva is right for them."
The FDA cautioned that nocturia can be caused by a wide variety of conditions, "such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Before considering Noctiva, healthcare providers should evaluate each patient for possible causes for the nocturia, and optimize the treatment of underlying conditions that may be contributing to the nighttime urination. Because Noctiva is approved only for adults with nocturia caused by nocturnal polyuria, healthcare providers should confirm overproduction of urine at night with a 24-hour urine collection, if one has not been obtained previously."
Moreover, the FDA warned that underlying conditions, including congestive heart failure, could make use of the drug unsafe.
Noctiva is taken 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 approval was based on two 12-week, randomized, placebo-controlled trials in 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Both studies demonstrated only a small benefit compared with placebo, but "more patients treated with Noctiva were able to at least halve their number of nighttime urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations."
The drug will carry a boxed warning that it can cause hyponatremia, which can be life-threatening if severe.
"Noctiva should not be used in patients at increased risk of severe hyponatremia, such as those with excessive fluid intake, those who have illnesses that can cause fluid or electrolyte imbalances, certain patients with kidney damage, and in those using certain medicines, known as loop diuretics or glucocorticoids," the FDA said. The drug should not be used in pregnant women or children.
Side effects included nasal discomfort, nasal congestion, sneezing, hypertension, nose bleeds, bronchitis, and dizziness.
Noctiva is marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC.
Source: http://www.medpagetoday.com/urology/urology/63578