The Scottish Medicines Consortium has approved the use of oral lyophilisate desmopressin (Noqdirna), the first licensed treatment for nocturia due to idiopathic nocturnal polyuria in adults.
The medicines watchdog said in its advice document that the drug was accepted for “restricted” use within NHS Scotland for patients aged 65 years and over.
“Nocturia can have a significant impact on a patient’s quality of life”
Bladder Health UK
Two placebo-controlled trials demonstrated that desmopressin, at licensed doses over three months, significantly reduced the mean number of nocturnal voids and resulted in higher proportions of responders compared with placebo, in patients with nocturia, said the SMC.
Ferring Pharmaceuticals, which markets the drug, said significantly reduced the average number of night-time urinations, compared with the placebo groups and was shown to nearly double the probability of patients achieving the primary endpoint of the studies.
It was also shown to reduce nocturnal urine volume in men and women by more than 200ml, as well as, increase the time to first void in people with nocturia, allowing people to have an average undisturbed sleep period of approximately 4.5 hours.
The drug’s once-daily melt formulation is administered sublingually without the need for water and is available in gender-specific low doses, tailored specifically for men (50μg) and women (25μg).
Ferring noted that nocturia affected around 8.63 million people in the UK, with night time overproduction of urine, or nocturnal polyuria, thought to contribute in up to 76-88% of these cases.
The product contains the active substance desmopressin acetate as lyophilisate, a synthetic analogue of the naturally occurring vasopressin, which is an antidiuretic hormone that promotes water absorption by the kidneys.
It works by mimicking the effect of vasopressin, binding to specific receptors in the kidneys, concentrating urine and leading to reduced night-time production.
In a statement, the charity Bladder Health UK said: “Nocturia can have a significant impact on a patient’s quality of life, and on that of their partners.
“The act of getting up in the middle of the night to pass urine and sometimes several times, is also particularly concerning in the elderly, because of the risk of trips and falls,” it said.
“We welcome the addition of Noqdirna as a treatment option to improve the lives of our patients and help restore their independence,” said the charity.