• Ferring Pharmaceuticals has successfully finalised a Decentralised Procedure (DCP) in the EU leading to the approval of NOCDURNA® (desmopressin) for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults
• National Marketing Authorisations are expected in the majority of EU countries in the following months
• Nocturia is the frequent need to pass urine during the night1 and the most common cause of sleep disturbance2
• The night-time overproduction of urine, nocturnal polyuria, is responsible for nocturia in up to 88% of cases3,4
Saint-Prex, Switzerland, 3 May 2016 - Ferring Pharmaceuticals today announced that NOCDURNA® (desmopressin) has received approval in the EU for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults.
Nocturia, the need to awaken at night to pass urine, is a complex medical condition with various contributing factors5. The night-time overproduction of urine, nocturnal polyuria, is responsible for nocturia in up to 88% of cases5,6.
Specifically developed to reduce the amount of urine the kidneys produce, NOCDURNA® once-daily lyophilisate tablets are administered sublingually (without the need for water) in gender specific low doses, tailored specifically for men (50 mcg) and women (25 mcg).
NOCDURNA® was reviewed via the Decentralised Procedure (DCP) with the Swedish Medical Products Agency (MPA) acting as the Reference Member State (RMS). The majority of the EU countries were involved as concerned member states and they will have 30 days to issue a national approval. Product labelling has been agreed by all countries participating in the procedure who will issue their own local Marketing Authorisations. NOCDURNA® is currently available in Canada for the treatment of nocturia.
Commenting on the authorisation, Pascal Danglas, MD, Chief Medical Officer at Ferring Pharmaceuticals, said, “We are delighted that NOCDURNA® received approval in the EU. The approval is a significant milestone in making this medicine also available to elderly patients diagnosed with nocturia due to nocturnal polyuria, a large patient population who previously had limited treatment options. The long and thorough development process has enabled us to provide gender-specific dosages, enabling a personalised medicine approach for men and women. Ferring Pharmaceuticals remains committed to improving the diagnosis and treatment of nocturia and to ensuring that patients of all ages continue to benefit from these treatment advances.”
The Swedish approval is based on two Phase III studies (CS40 and CS41) with CS40 investigating the efficacy and safety of 25 mcg in adult women and CS41 investigating the efficacy and safety of 50 mcg in adult men. Both trials demonstrated that the treatment significantly reduced the average number of night time urinations compared to the placebo groups7,8, with nearly doubling the probability of patients reducing the number of night-time urinations by more than 33 percent8,9.
The drug was well tolerated. The most common adverse events were dry mouth, nausea, fatigue, hyponatraemia and headache which occurred at ≥5%8,9. No incidences of hyponatraemia occurred in CS408 and only two incidences of hyponatraemia occurred in patients in CS41 who took the 50 mcg dose (≤1%)9.
“The broken night’s sleep caused by nocturia can have a negative impact on quality of life, daily activity and work productivity9,10,” said Jens Peter Nørgaard, MD, Executive Director and Professor Global Medical Affairs Urology at Ferring Pharmaceuticals. “Longer term effects are being studied, but poor quality sleep has been associated with significant health problems including obesity, diabetes, weakened immune systems and even some cancers11,12,13, Therefore we are pleased with the approval of a treatment that can significantly decrease the burden experienced by nocturia patients.”
Oral desmopressin is currently registered and widely available outside the US for the treatment of nocturia associated with nocturnal polyuria in higher doses, but with an upper age limitation of 65 years. Although trials with NOCDURNA® have documented a safety benefit of lower, gender specific doses, sodium monitoring in adults over 65 years of age is warranted.
- ENDS -
NOCDURNA® Oral lyophilisate has as an active substance desmopressin, a synthetic analogue of the naturally occurring vasopressin, an antidiuretic hormone that promotes water absorption by the kidneys. Ferring Pharmaceuticals originally developed desmopressin more than 40 years ago. Desmopressin in NOCDURNA® works by mimicking the effect of vasopressin and binds to specific receptors in the kidneys. This action can prevent the kidneys from filtering excessive amounts of water out of the blood as they make urine, reducing the volume of urine and night-time urination. However, desmopressin, unlike vasopressin, does not affect blood pressure.
Desmopressin has been approved in both adults and children and in multiple strengths, dosage forms and routes of administration worldwide for more than 40 years for several medical conditions, such as for central diabetes insipidus and for primary nocturnal enuresis (involuntary discharge of urine at night by children beyond the age of five years). Ferring Pharmaceuticals has already received marketing authorisation in 80 countries for desmopressin orally disintegrating tablets indicated for the symptomatic treatment of nocturia associated with nocturnal polyuria in adults.
Nocturia is the need to awaken at night to void. Many factors can contribute to nocturia, such as an underlying medical condition. However, some people experience nocturia due to nocturnal polyuria, which means a person makes too much urine at night, although their total 24-hour production may remain normal. The broken night’s sleep caused by nocturia also leads to many short and long term health effects12,13,14. In the short term lack of sleep can have a negative impact on our attention span, memory recall and learning15. Longer term effects are being studied, but poor quality sleep or sleep deprivation has been associated with significant health problems, such as obesity, diabetes, weakened immune systems and even some cancers12,13,14. Lack of sleep is also related to many psychological conditions such as depression, anxiety and psychosis15,16.
Nocturia rates range from 29 to 59 percent in men older than 70 and 28 to 62 percent in women older than 7017. Between 63 to 75 percent of patients with nocturia believe it is troublesome18. Nocturia is a serious medical condition that can cause poor sleep quality, which leads to feeling tired, reduced quality of life and decreased productivity, according to the International Consultation on Incontinence Research Society19,20. Studies have related nocturia to increased rates of death, risks of falls, night sweats and leg cramps and tingling19.
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 www.ferring.com.
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19Message Grid prepared by 3D, Oct. 7 2014, page 13
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