Ferring Pharmaceuticals Announces UK Launch of NOQDIRNA® (oral lyophilisate desmopressin), the Only Licensed Treatment for Adults of All Ages Waking Multiple Times to Urinate at Night
WEST DRAYTON, England, November 1, 2016 /PRNewswire/ --
- NOQDIRNA® is the only licensed treatment for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults, including the over 65s - a new low dose tailored to men and women.[1]
- Nocturia is a complex condition characterised by the need to wake up once or more during the night to urinate (or void the bladder).[2] Waking up to void two or more times a night is considered bothersome.[3]
- Nocturnal polyuria is associated with up to 76-88% of nocturia cases.[4],[5]
- Nocturia, and the associated loss of sleep, has been linked with increased morbidity and mortality,[6],[7] a decreased quality of life,[8] and an increased risk of falls and fractures, particularly in older people who are most likely to be affected by nocturia.[9],[10]
Ferring Pharmaceuticals today announced the launch of NOQDIRNA® (oral lyophilisate desmopressin) - the only licensed treatment for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults including the over 65s - following approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA). Nocturia, the need to wake at night to pass urine, is a complex medical condition, impacting around 8.63 million people in the UK[11] - night-time overproduction of urine, or nocturnal polyuria, is thought to contribute in up to 76-88% of these cases.[4],[5]
Nocturia can result in an increase in falls and fractures, due to the need for night-time bathroom trips or due to sleepiness during the day.[9],[10] In addition to increased falls and fractures, poor sleep associated with nocturia can impact physical, mental and emotional health in adults of all ages, leading to reduced daytime productivity, a decreased quality of life and an increased morbidity and mortality[6],[7],[8],[9],[10],[11] - with studies having shown that waking up two or more times a night to urinate increases a person's risk of mortality by up to 22%.[7]
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 a year through work absenteeism and loss of productivity.[11]
Commenting on the launch, Steve Howson, Ferring UK's General Manager, said, "We are delighted that NOQDIRNA® can now be made available to patients in the UK. This is a significant milestone in making sure patients of all ages, including those over 65 years old, have a treatment option to help reduce the burden of their condition. Ferring Pharmaceuticals remains committed to improving the diagnosis and treatment of nocturia, and to ensuring that patients continue to benefit from these treatment advances".
Developed to reduce the amount of urine the kidneys produce, NOQDIRNA®
once-daily lyophilisate tablets are administered sublingually without the need for water in gender-specific, low doses, tailored specifically for men (50 µg) and women (25 µg).
The approval of NOQDIRNA® is based on two Phase III studies (CS40 and CS41), with CS40 investigating the efficacy and safety of 25 µg in adult women and CS41 investigating the efficacy and safety of 50 µg in adult men.[12],[13] Both trials demonstrated that the treatment significantly reduced the average number of night-time urinations, compared with the placebo groups. NOQDIRNA® was shown to nearly double the probability of patients achieving the primary endpoint of the studies - listed as a reduction of night-time voids by 33%. NOQDIRNA® was also shown to reduce nocturnal urine volume in men and women by more than 200 ml, and increase time to first void in people with nocturia, allowing people to have an average undisturbed sleep period of approximately 4.5 hours. This extended undisturbed sleep is important due to the early hours of sleep making up the majority of the night's deep sleep - interruption of which is associated with a range of health issues.[12],[13]
Overall, the drug was well tolerated with the most common adverse events being dry mouth, nausea, fatigue and headache which occurred at ≥5%. There was no incidence of severe hyponatraemia in CS40 and only two cases of severe hyponatraemia occurred in patients in CS41 who took the 50 µg dose (≤1%).[12],[13]
James Green, Urology Network Lead at Barts Health and Visiting Professor at London South Bank University said, "Nocturia is a worrying problem for patients and their partners. Constantly getting up at night to pass urine has a major impact on patient's quality of life, and in the elderly it increases the risk of trips and falls. Having a new formulation that can help with this will make a real difference to thousands of patients".
Oral desmopressin has previously been available in higher doses for other indications, however this approval came with an upper age limitation of 65 years. Trials with NOQDIRNA® have documented the treatment of lower, gender-specific doses to be effective and well tolerated in adults of all ages, though sodium monitoring in adults over 65 years of age is warranted.[12],[13]
Jonathan Rees, GP, Tyntesfield Medical Group, North Somerset, Founder of the Primary Care Urology Society welcomed the news. "Nocturia is a very common symptom encountered in primary care and can be very difficult to treat effectively. We know that nocturia can have a significant impact on quality of life, and also increased risk of falls and fractures. Nocturnal polyuria often does not respond to lifestyle changes or medication currently available, so the addition of Noqdirna to our armoury is highly welcome, particularly as we can now use this in patients over 65 unlike existing desmopressin formulations."
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.[12],[13]
Desmopressin has been approved worldwide in both adults and children, in multiple strengths, dosage forms and routes of administration since Ferring Pharmaceuticals originally developed it more than 40 years ago. It has been indicated in several medical conditions, such as central diabetes insipidus and primary nocturnal enuresis (bedwetting by children beyond the age of five years).
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).[2] 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.[4],[5] 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.[14],[15],[16] 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[11] 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.[9],[10]
Nocturia is a leading cause of sleep disturbance across all ages[17] 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.[18] 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.[6],[7],[8],[9],[10],[11]
Between 58-66% of women and men aged 50-59 have reported experiencing nocturia, and between 63-75% of patients with nocturia believe it is troublesome.[14] 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.[11]
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.
References:
1. Noqdirna (oral lyophilisate desmopressin as acetate) Summary of Product Characteristics.
2. Van Kerrebroeck P et al. Neurourol Urodyn 2002;21:179-183.
3. Everaert K et al. Practical Functional Urology, Springer 2016. Edited by Heesakkers et al. Pp 377-392.
4. Weiss JP et al. J Urol 2011;186:1358-13636.
5. Weiss JP et al. BJU Int 2013;111:700-716.
6. Bursztyn M et al. Am J Cardiol 2006;98:1311-1315.
7. Fan Y et al. Int J Cardiology 2015;195:120-122.
8. Orzel-Gryglewska, J. IJOMEH 2010; 23(1): 95-114. doi:10.2478/v10001-010-0004-9.
9. Nakagawa H et al. Neurourol Urodyn 2008;27:674-5.
10. Asplund R. Arch Gerontol Geriatr 2006; 43(3):319-26.
11. Weidlich D et al. Eur J Health Econ 2016. DOI 10.1007/s10198-016-0826.
12. Sand PK et al. J Urol 2013;190(3):958-964. doi: 10.1016/j.juro.2013.02.037.
13. Weiss JP et al. J Urol 2013;190(3):965-972. doi: 10.1016/j.juro.2012.12.112
14. Laureanno, P., Ellsworth, P. Urol Nurs. 2010;30(5):276-287.
15. Kupelian V. Eur Urol 2012;61:78-84.
16. Yazici CM & Kurt O. Res Rep Uro 2015:7 57-63
17. Middlekoop H et al. J Gerontol 1996;51A:108-15.
18. Torimoto K et al. J Urol 2013;189: e557-e558
Date of preparation: October 2016
NOQ/2573/2016/UKc
Share this article