Ferring announced the availability of Nocdurna (desmopressin acetate) sublingual tablets for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least 2 times per night to void. It is the first sublingual tablet approved by the Food and Drug Administration (FDA) for this condition.
Nocdurna, a vasopressin analog, was initially approved in June 2018 based on data from 3 double-blind, placebo-controlled, multicenter, randomized trials plus 1 open-label extension trial of up to 3 years in 220 patients aged ≥18 years. Nocdurna has specific sex-based dosing: women are prescribed 27.7mcg daily whereas men are prescribed 55.3mcg daily; it should be taken 1 hour before bedtime without water.
The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water reabsorption in the kidneys, and reducing urine production.
Nocdurna carries a Boxed Warning describing the risk of hyponatremia, which can be life-threatening if severe. Patients’ serum sodium levels should be normal prior to treatment start or resuming treatment. Serum sodium should be measured within 1 week and approximately 1 month after starting treatment and periodically during treatment; more frequent monitoring is required for elderly (≥65 years) and in patients at risk for hyponatremia.
Nocdurna is available as 27.7mcg and 55.3mcg sublingual tablets in 30-count cartons (3 blister packs with 10 tablets each).
For more information call (888) 337-7464 or visit Nocdurna.com.