FDA approves Noctiva, the first treatment for frequent nighttime urination.

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The U.S. Food and Drug Administration today approved Noctiva (desmopressin acetate) nasal spray for adults who have to go for urination at least two times per night, a condition known as nocturnal polyuria. [1]

Noctiva is the first FDA-approved treatment for this condition. About 200 million people worldwide suffer from nocturia.

It is manufactured by Serenity Pharmaceuticals, LLC and marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC.

Hylton V. Joffe, M.D., M.M.Sc., director of the Division of Bone, Reproductive, and Urologic Products in the FDA’s Center for Drug Evaluation and Research 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,”  he further added  “It is important to know that Noctiva is not approved for all causes of night-time urination, so patients should discuss their symptoms with their health care provider who can determine the underlying cause of the night-time urination and whether Noctiva is right for them.”

Noctiva can be a symptom of many underlying pathologies of the bladder or prostate, diabetes, side effect of some medications and congestive cardiac failure. It prevalence increases with age and is common in men and women. FDA advises the physician to fully investigate a patient for underlying cause, prescribe medicines and manage the medical condition before putting him/her on Noctiva.

He should also get a 24-hour urine collection to confirm the diagnosis of nocturia.

Desmopressin is a nasal spray, to be taken every day ,30 minutes before bedtime. It acts on Kidneys to increase absorption of water from the tubules.

FDA approved the drug after the results of a placebo control trial of 1050 subjects over 50years of age showed that more number of patients on the drug halved the frequency of one night urination and decreased the number of nights with one or more trips to the bathroom.

The side effects of desmopressin to cause hyponatremia, requires that the manufacturer should put medication guide and boxed warning on the package.  Physician should always check the sodium level of the patient before and during therapy periodically.

Contraindicated is patients with hyponatremia, electrolyte imbalance, renal damage, symptomatic CCF, uncontrolled hypertension, pregnancy, gestational DM and patients on steroids and loop diuretics.

The full text of the FDA press announcement can be accessed here.

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[1] https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm