FDA says new nasal spray reduces frequent urination.
The US Food and Drug Administration (FDA) approved a remedy for adults who awaken at least two times a night because they have to urinate. The product is a nasal spray formulation of desmopressin acetate (Noctiva/Serenity Phamaceuticals/Renaissance Lakewood.)
It was approved by the FDA's Division of Bone, Reproductive, and Urologic Products, part of the Center for Drug Evaluation and Research.
The drug comes with a boxed warning since it can cause low sodium levels in the blood (hyponatremia) which can be life-threatening. It should not be taken by certain patients with kidney damage or those taking loop diuretics or glucocorticoids.
The FDA noted that the product is not approved for all causes of night-time urination. There are a variety of conditions that can cause such excessive urination including poorly controlled diabetes mellitus, medications, and diseases of the bladder and prostate. Physicians are urged to evaluate each patient to decide whether the underlying condition is treated as fully as possible before prescribing the drug.
A 24-hour urine collection is also recommended. Physicians should also check patients' sodium levels within one week and again at one month after patients start taking the drug.
Noctiva is taken daily about 30 minutes before going to bed. It works by increasing the absorption of water through the kidneys.
It's efficacy was shown in a trial of 1,045 patients age 50 and older who had the problem. The drug study showed only "a small reduction in the average number of night-time urinations" but that more patients who took the drug halved their number of night-time urination than did patients on a placebo.
The FDA noted also that there are other medications that contain desmopressin, but none are approved for nocturia.