NOCDURNA (desmopressin) has received approval in the European Union (EU), for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults, announced Ferring Pharmaceuticals.
Nocturia, the need to awaken at night to pass urine, is a complex medical condition with various contributing factors.1 The night-time overproduction of urine, nocturnal polyuria, is responsible for nocturia in up to 88% of cases.1,2
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.
Pascal Danglas, MD, chief medical officer at Ferring Pharmaceuticals, says in a release, “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 personalized 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.”
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.
1. Park, H.K. and Kim, H.G., Current Evaluation and Treatment of Nocturia, Korean J Urol. Aug 2013; 54(8): 492–498. page 492. Published online Aug 7, 2013. doi: 10.4111/kju.2013.54.8.492 PMCID: PMC3742899.http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3742899/
2. Weiss JP, van Kerrebroeck PEV, Klein BM, Nørgaard JP. Excessive nocturnal urine production is a major contributing factor to the etiology of nocturia. J Urol 2011; 186: 1358-63