FDA approves first treatment for frequent urination at night due to overproduction of urine

FDA approves first treatment for frequent urination at night due to overproduction of urine

FDA approves first treatment for frequent urination at night due to overproduction of urine

 

USFDA has approved Noctiva (desmopressin acetate) a nasal spray for adults with nocturnal polyuria on 3rd March 2017. Polyuria is overproduction of urine during the night, it awakens people at least two times per night to urinate.

Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products said “Today’s approval provides adults who overproduce urine at night with the first FDA-approved therapeutic option to help reduce the number of times a night they wake up to urinate”. It is important to know that Noctiva is not approved for all causes of night urination.

Nocturia (wakening at night to urinate) is a symptom that 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. Noctiva can cause nocturia therefore patients should discuss their underlying conditions with health care providers. Noctiva is taken daily, approximately 30 minutes before going to bed.

Desmopressin acetate absorbs the water from kidney which produces less urine. Desmopressin acetate’s efficacy was established in two 12-week, randomized, placebo-controlled trials in 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Noctiva can cause low sodium level in blood (hyponatremia) or severe hyponatremia hence health care provider should check patients sodium level before administering Noctiva. The lower Noctiva dose is recommended as the starting dose for those who may be at risk for hyponatremia, such as the elderly. 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.

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