NOCDURNA is the first and only sublingual tablet indicated for treatment of nocturia due to nocturnal polyuria in adults awakening at least 2 times per night to urinate.
The US Food and Drug Administration (FDA) approved desmopressin acetate (NOCDURNA), the first sublingual tablet for treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to urinate, announced Ferring Pharmaceuticals.
The approval is backed by data of 3 double-blind, placebo-controlled randomized trials and 1 open-label extension trial of up to 3 years, in patients 18 years and older. The formulation of the rapidly dissolving tablets and sex-specific dosing was effectively demonstrated in reducing nighttime bathroom trips.
“Millions of individuals across the country face nocturia each night, many of whom suffer the daytime consequences of fatigue and lost productivity,” Jeffrey Weiss, MD, FACS, professor, chairman of urology, State University of New York Downstate Medical Center, said in a statement. “NOCDURNA offers the first sublingual tablet that can target the source of nighttime urination, the kidney, and effectively reduce the number of times patients have to wake up each night to urinate.”
In clinical trials 1 and 2, the co-primary endpoints included 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 3 months of treatment.
The trials demonstrated an average reduction of nocturnal voids of 52% in women (n=102) and 43% in men (n=102), relative to the mean baseline (2.9 for women and 3 for men) with a reduction of 1.5 and 1.3, respectively.
Additionally, 78% of women and 67% of men receiving NOCDURNA achieved a 33% reduction in mean number of voids throughout a 3-month period when compared to baseline.
Common adverse effects with an incidence greater than 2% included dry mouth, dizziness and hyponatremia, however, NOCDURNA was approved with a boxed warning because of its possibility to cause hyponatremia.
NOCDURNA acts on receptors in the kidney in order to absorb additional fluid and produce less urine during the night.
The treatment will be made available in the US in the second half of 2018.