General Information

Nocdurna (desmopressin acetate) is a vasopressin analog.

Nocdurna is specifically indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.

Nocdurna is supplied as a tablet for sublingual administration. Before starting or resuming Nocdurna assess the sodium concentration and only start or resume Nocdurna in patients with a normal serum sodium concentration. The recommended Nocdurna dosage in women is 27.7 mcg once daily, one hour before bedtime, administered sublingually without water. The recommended Nocdurna dosage in men is 55.3 mcg once daily, one hour before bedtime, administered sublingually without water. The tablet should be kept under the tongue until it has fully dissolved. Patients should empty their bladder immediately before bedtime. Fluid intake should be limited to a minimum from 1 hour before until 8 hours after administration.

Clinical Results

FDA Approval

The FDA approval of Nocdurna was based on three double-blind placebo-controlled, multi-center, randomized trials and one open-label extension trial of up to three years in patients 18 years and older. Included in the clinical trials were patients also taking OAB or BPH medications. The co-primary endpoints in studies 1 and 2 were the change in number of nighttime voids compared to baseline, and the percentage of patients who achieved at least a 33% reduction from baseline in the mean number of nighttime voids during three months of treatment. Clinical trials demonstrated an average reduction of nocturnal voids of 52% in women (n=118) and 43% in men (n=102) relative to mean baseline (reduction of 1.5 and 1.3 voids respectively). The mean baseline was 2.9 for women and 3.0 for men. Also, 78% of women and 67% of men receiving Nocdurna achieved a 33% reduction in mean number of nocturnal voids over a three month period compared to baseline.

Side Effects

Adverse effects associated with the use of Nocdurna may include, but are not limited to, the following:

dry mouth

hyponatremia or blood sodium decreased

dizziness

The Nocdurna drug label comes with the following Black Box Warning: Nocdurna can cause hyponatremia, which may be life threatening if severe. Nocdurna is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids. Ensure serum sodium concentration is normal before starting or resuming Nocdurna. Measure serum sodium within 1 week and approximately 1 month after initiating therapy and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia. If hyponatremia occurs, Nocdurna may need to be temporarily or permanently discontinued.

Mechanism of Action

Nocdurna (desmopressin acetate) is a sublingual tablet containing desmopressin acetate, a synthetic analog of the endogenous pituitary hormone, 8-arginine vasopressin (ADH), an antidiuretic hormone. The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidneys, and reducing urine production.