FDA Approval for Intranasal Desmopressin: Relief for People With Nocturnal Polyuria

Intranasal desmopressin has been approved by the United States Food and Drug Administration for the treatment of nocturnal polyuria.

Highlights:

The United States Food and Drug Administration has approved the use of intranasal desmopressin for the treatment of nocturnal polyuria
Desmopressin reduces urine production and therefore the number of times the person has to empty the bladder at night
Other causes of nocturia should be ruled out before it is prescribed

The U.S. Food and Drug Administration has approved the use of desmopressin acetate nasal spray with the trade name Noctiva for the treatment of nocturnal polyuria.

Nocturnal polyuria is a condition where the person has to get up at least two times per night to pass urine due to overproduction of urine. Waking up repeatedly disturbs and interrupts sleep, and can cause increased daytime sleepiness.

Bladder Spasms - Causes, Symptoms, Complications, Diagnosis, Treatment, Prevention
Bladder contraction may cause spasms, an introduction into the various causes of bladder spasms, clinical symptoms, investigation and treatment modalities.

‘Nocturnal polyuria disturbs sleep and affects quality of life. The FDA has approved intranasal desmopressin to provide relief for nocturnal polyuria.’

Nocturnal polyuria should be differentiated from nocturia; nocturia refers to waking up at night to pass urine, which could be due to any cause. Some of these are:

Increased intake of fluid before sleeping at night
Overactive bladder
Underlying illness like diabetes mellitus, diabetes insipidus or congestive cardiac failure
Prostate problems like infection and prostate enlargement
Urinary infection
Swelling of the lower legs, due to re-distribution of fluid at night
Pregnancy

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.”

“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.”

Studying the Efficacy of Desmopressin

The efficacy of desmopressin was studied in a two 12-week, randomized placebo controlled trial with 1,045 nocturia patients who were 50 years or older.

New Radiology Treatment Helps Men with Enlarged Prostate
The treatment called prostatic artery embolization improved the quality of life and sleep pattern for men with enlarged prostates and lower urinary tract symptoms.

Even though, these patients showed only a small reduction in the average number of night-time urinations with desmopressin when compared to placebo. The trial found that patients treated with the drug were able to halve their number of night-time urinations and were able to sleep for more nights with either one or fewer night-time urinations.

Desmopressin

Desmopressin is an analogue of the hormone vasopressin that is secreted by a small gland at the base of the brain called the pituitary. Vasopressin helps to reabsorb water from the kidneys and therefore reduces the amount of urine formed. It has been used to treat central diabetes insipidus, a condition characterized by reduced vasopressin levels.

Benign Prostatic Hyperplasia (BPH) Causes Symptoms Diagnosis Treatment FAQs
Benign Prostatic Hyperplasia (BPH) or Benign Enlargement of Prostate (BEP) is an increase in the size of the prostate. The prostate is a walnut sized gland that is part of the male reproductive system.

The spray is administered into the nose around 30 minutes before going to bed at night. It can cause nasal congestion, discomfort and bleeding as side effects.

To understand if a person can use intranasal desmopressin, a 24-hour urine collection should be done. This will help to differentiate nocturia due to urine overproduction (nocturnal polyuria) from other causes of nocturia, where this drug cannot be used.

Urinary Incontinence in women - Bladder Diary
The 24-hour bladder diary can provide an accurate record of urinary output, frequency of voiding, frequency and nature of incontinent episodes, as well as type and volume of fluid intake.

Desmopressin should be avoided in the following individuals with nocturia:

People who drink excessive fluid
Symptomatic congestive heart failure patients or uncontrolled hypertension due to its ability to cause fluid retention and worsen these conditions
People at risk for low sodium levels. Desmopressin can cause low blood sodium levels that can be life-threatening especially in the elderly; blood sodium levels should be regularly monitored during treatment. Risk factors for low sodium levels include:

Excessive fluid intake
Presence of illnesses that can cause fluid or electrolyte imbalances
Certain types of kidney damage
Intake of loop diuretics or glucocorticoids

People with nasal conditions like colds or allergies due to problems with absorption. It can be continued once the patient is better.
During pregnancy or in children

Reference:

FDA approves first treatment for frequent urination at night due to overproduction of urine - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm544877.htm)

Source-Medindia