The FDA has approved Nocdurna for the treatment of nocturia due to nocturnal polyuria .- Ferring.

The FDA has approved Nocdurna (desmopressin acetate sublingual tablets; Ferring) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. The approval was based on 3 double-blind, placebo-controlled trials and 1 open-label extension trial of up to 3 years in patients greater than 18 years old. In clinical trials, nocturnal polyuria was defined as nighttime urine production exceeding one-third of the 24-hour urine production.

The efficacy of Nocdurna was established in two 3-month trials; Study 1 enrolled only women while Study 2 enrolled only men. In Study 1, women (N=237) were randomized to receive either sublingual Nocdurna 27.7mcg or placebo every night approximately 1 hour before bedtime; men (N=230) in Study 2 received either sublingual Nocdurna 55.3mcg or placebo. The co-primary endpoints in both trials were: 1) change in number of nocturia episodes/night from baseline during the 3-month period and; 2) 33% responder status during 3 months of treatment (a decrease of 33% in the mean number of nocturnal voids compared to baseline). Results showed an average reduction of nocturnal voids from baseline of -1.5 (difference from placebo -0.3) for women and -1.3 for men (difference from placebo -0.4) with Nocdurna. In addition, 78% of women and 67% of men in the Nocdurna group achieved 33% responder status vs 62% and 50% for placebo, respectively.

Nocdurna will be available in the second half of 2018 as a sublingual tablet in two dosage strengths: 27.7mcg (for women) and 55.3mcg (for men), both in 30-count cartons. The recommended dose for women is lower as women were more sensitive to the effects of Nocdurna and had a higher risk of hyponatremia with the higher dose in clinical trials.