Ferring Pharmaceuticals: The Scottish Medicines Consortium Approves Use of NOQDIRNA® (oral lyophilisate desmopressin), the First Licensed Treatment for Nocturia due to Idiopathic Nocturnal Polyuria in Adults

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Ferring Pharmaceuticals

08 Aug, 2017, 12:08 GMT

WEST DRAYTON, England, August 8, 2017 /PRNewswire/ --

  • The Scottish Medicines Consortium (SMC) has announced today a positive decision for the use of NOQDIRNA®.[1]
  • 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.[2]
  • Nocturia is a complex condition characterised by the need to wake up once or more during the night to urinate.[3] Waking up to void two or more times a night is considered bothersome.[4]
  • Nocturnal polyuria is associated with up to 76-88% of nocturia cases.[5],[6]
  • Nocturia, and the associated loss of sleep, has been linked with increased morbidity and mortality,[7],[8] a decreased quality of life,[9] and an increased risk of falls and fractures, particularly in older people who are most likely to be affected by nocturia.[10],[11]

Ferring Pharmaceuticals today announced that the Scottish Medicines Consortium (SMC) has given a positive decision for the use of NOQDIRNA®.[1]

"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.12 Night-time overproduction of urine, or nocturnal polyuria, is thought to contribute in up to 76-88% of these cases.[5],[6] 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.[12]

"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.[7-12]

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%.[8]

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.

About NOQDIRNA®  

NOQDIRNA® oral lyophilisate 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. Desmopressin in NOQDIRNA® works by mimicking the effect of vasopressin, binding to specific receptors in the kidneys, concentrating urine and leading to reduced night-time production.[13],[14]

About Nocturia  

Nocturia is a complex condition characterised by the regular need to awaken once or more during a night to urinate (or void the bladder).[3] Although there are several reasons why people may be affected by nocturia, the night-time overproduction of urine - known as nocturnal polyuria - contributes in up to 76-88% of cases.[5],[6] Factors other than nocturnal polyuria that contribute to nocturia include an overactive bladder, enlarged prostate, weakened bladder muscles, cystitis, obesity, diabetes, and use of diuretics.[15],[16],[17] A person with nocturnal polyuria makes too much urine at night, even though their total 24-hour production may remain normal.

Nocturia affects up to 8.63 million people in the UK[12] and can impact those living with the condition in a variety of ways. Increased risk of falls and fractures due to nocturia can be particularly problematic for older people, who are more prone to fractures and are most likely to be affected by nocturia. Falls may arise directly from the need to make night-time trips to the bathroom or due to sleepiness during the day.[10],[11]

Nocturia is a leading cause of sleep disturbance across all ages[18] and has been associated with significant health problems, such as obesity, diabetes, a weakened immune system and even some cancers. Lack of sleep is related to many psychological conditions, such as depression, anxiety and psychosis, and may lead to feelings of tiredness, reduction in daytime productivity and a decreased quality of life. The early hours of sleep include the majority of the night's slow-wave sleep, which is very important - adults with nocturia spend 35% less time in slow-wave sleep than those without nocturia.[19] Studies also suggest that lack of sleep due to nocturia is associated with an increased mortality rate, night sweats, leg cramps and problems with perception and balance leading to increased falls and injuries.[7-12]

Between 58 and 66% of women and men in the age group 50-59 years have reported experiencing nocturia, and between 63 and 75% of patients with nocturia believe it is troublesome.[15] In the UK, it is estimated that the economic burden is £1.35 billion a year through hospital costs of managing nocturia and its associated consequences, and £4.32 billion a year through work absenteeism and loss of productivity.[12]

About Ferring Pharmaceuticals  

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology-oncology, gastroenterology, endocrinology and orthopaedics. Ferring Pharmaceuticals has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring Pharmaceuticals or its products please visit http://www.ferring.com

For further information: Lis Cook, Tel. +44(0)7825-380-348, lis.cook@ferring.com ; Sarah Contiero, Tel. +44(0)20-3595-2471, scontiero@axon-com.com

References:

  1. https://www.scottishmedicines.org.uk/SMC_Advice/Advice/1218_17_desmopressin_Noqdirna/desmopressin_Noqdirna_Resubmission
  2. Ferring NOQDIRNA® (oral lyophilisate desmopressin as acetate). Summary of Product Characteristics.
  3. Van Kerrebroeck P et al. Neurourol Urodyn 2002;21:179–83.
  4. Everaert K et al. Practical Functional Urology, Springer 2016. Edited by Heesakkers et al. Pp 377–92.
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  17. Yazici CM, Kurt O. Res Rep Urol 2015;7 57–63.
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  19. Torimoto K et al. J Urol 2013; 189(Suppl):e557–e558.