Nocdurna was marketed in Denmark in August 2016 for symptomatic treatment of nocturia caused by idiopathic nocturnal polyuria in adults. Nocdurna differs from existing desmopressin products by its lower strengths of respectively 25 µg and 50 µg per tablet, enabling a lower dose compared to other desmopressin tablets whose lowest dose is 60 µg. Nocdurna is especially suited for elderly patients as treatment with desmopressin in elderly patients is associated with a dose-dependent increased risk of hyponatraemia, which is the reason why the existing products on the market are not recommended in the elderly. Unlike the other desmopressin products, Nocdurna is not authorised for treatment of nocturnal enuresis and diabetes insipidus.
In comparable placebo studies, the efficacy of Nocdurna proved modest with a reduction in the number of night time urinations of 1.46 in women and 1.25 in men compared to 1.24 in the female placebo group and 0.88 in the male placebo group, corresponding to a difference of 0.22 night time urinations in women and 0.37 in men. The incidence of hyponatraemia in Nocdurna treatment was approx. 1 % in women and 3 % in men and was primarily seen in elderly people over 65. Nocdurna is not authorised in the USA since it is not believed that the modest effect justifies the adverse reactions.
It is IRF's overall assessment that Nocdurna treatment cannot be recommended to treat nocturia caused by idiopathic nocturnal polyuria in adults because the effect is too modest compared to the price and adverse reactions. The treatment could be considered for patients who have not responded adequately to lifestyle intervention regarding fluid intake and urination in the evening hours, but if no clinically relevant improvement is seen within approx. 1 month, it should be considered to stop treatment. For the treatment of especially elderly patients, Nocdurna should be preferred over the other desmopressin products due to the lower dose.