Ferring Pharmaceuticals announced that NOCDURNA® (desmopressin) has received approval in the EU. It is used for the symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults. Nocturia is complex medical condition with the need to wake and pass urine at night.
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). NOCDURNA® is currently available in Canada for the treatment of nocturia.
Pascal Danglas, MD, Chief Medical Officer at Ferring Pharmaceuticals, said, “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 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 indicate that the treatment significantly reduced the average number of night time urinations compared to the placebo groups, with nearly doubling the probability of patients reducing the number of night-time urinations by more than 33 percent.
