- The Scottish Medicines Consortium (SMC) has announced today a positive decision for the use of NOQDIRNA®.
- NOQDIRNA® is the only licensed treatment for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults, including the over 65s, and is available at a new low dose tailored to men and women.
- Nocturia is a complex condition characterised by the need to wake up once or more during the night to urinate. Waking up to void two or more times a night is considered bothersome.
- Nocturnal polyuria is associated with up to 76-88% of nocturia cases.
- Nocturia, and the associated loss of sleep, has been linked with increased morbidity and mortality, a decreased quality of life, and an increased risk of falls and fractures, particularly in older people who are most likely to be affected by nocturia.
Ferring Pharmaceuticals today announced that the Scottish Medicines Consortium (SMC) has given a positive decision for the use of NOQDIRNA®.
“The SMC decision is great news for patients and their families, as it now means they will have access to this effective treatment, for a condition that is complex to treat, can be very bothersome and have a severe negative impact on a patient’s independence and quality of life.”
Nocturia – the need to wake at night to pass urine – is a complex medical condition that impacts around 8.63 million people in the UK. Night-time overproduction of urine, or nocturnal polyuria, is thought to contribute in up to 76-88% of these cases. The burden to the UK economy is estimated to be £1.35 billion a year through hospital costs of managing nocturia and its associated consequences, and £4.32 billion through work absenteeism and loss of productivity.
“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”, said Bladder Health UK. “We welcome the addition of NOQDIRNA® as a treatment option to improve the lives of our patients and help restore their independence”.
In addition to increased falls and fractures, the poor sleep associated with nocturia can impact the physical, mental and emotional health of adults of all ages, leading to reduced daytime productivity, a decreased quality of life and an increased morbidity and mortality.
A study has shown that waking up two or more times a night to urinate increases a person’s risk of mortality by up to 22%.
NOQDIRNA® once-daily melt formulation is administered sublingually without the need for water is available in gender-specific low doses, tailored specifically for men (50 μg) and women (25 μg).
NOQDIRNA® significantly reduces 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 200 ml, 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.