FDA

FDA Approves New Nocturia Treatment

June 22, 2018

The US Food and Drug Administration has approved Nocdurna (desmopressin acetate) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least twice per night to void.

The first sublingual tablet approved for this indication, Nocdurna was granted approval following the success of 3 placebo-controlled, randomized trials and 1 open-label extension trial of up to 3 years among patients aged 18 years and older who were also taking medications for overactive bladder or benign prostatic hyperplasia.

Overall, women (n = 118) experienced an average reduction of nocturnal voids of 52%, and men (n = 102) experienced an average reduction of 43% compared with mean baseline. Over the course of 3 months, 78% of women and 67% of men who were treated with Nocdurna experienced a 33% reduction in the mean number of nocturnal voids.

The FDA noted that clinicians should ensure that patients’ serum sodium concentration is normal prior to initiating or resuming Nocdurna.

Patients with a high risk for severe hyponatremia—including those with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and those using loop diuretics or systemic or inhaled glucocorticoids—should not take Nocdurna.

—Christina Vogt

Reference:

Nocdurna (desmopressin acetate) now approved by U.S. FDA as first sublingual tablet to treat nocturia due to nocturnal polyuria [press release]. Parsippany, NJ. Ferring Pharmaceuticals Inc. June 21, 2018. https://www.businesswire.com/news/home/20180621006181/en/NOCDURNA®-desmopressin-acetate-Approved-U.S.-FDA-Sublingual Accessed on June 22, 2018.