Ferring Pharmaceuticals has announced the US launch of NOCDURNA (desmopressin acetate), a sublingual tablet indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken more than two times per night to void.
Now available by prescription in pharmacies across the US, NOCDURNA provides adults with a fast-acting, effective treatment that targets the kidneys, the underlying cause of NP.
The sublingual tablet formulation and sex-specific dosing has been shown to reduce night-time urination by nearly half in adults 18 years and older.
State University of New York (SUNY) Downstate Medical Center urology professor and chairman Jeffrey Weiss said: “The effects of nocturia are often discounted; however, many people don’t realize the impact that two or more nocturia episodes a night can have by disrupting sleep and causing people to wake up frequently.
“The availability of NOCDURNA provides US healthcare providers with an effective treatment option to address the underlying cause of nocturnal polyuria and help their patients reduce the number of times they get up each night to urinate.”
NOCDURNA received approval from the US Food and Drug Administration on June 21, 2018 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.
Clinical trials demonstrated a reduction of 1.5 nocturnal voids in women (n=118) and 1.3 nocturnal voids in men (n=102) relative to a mean baseline of 2.9 and 3.0 for men and women respectively.
Also, 78% of women and 67% of men achieved a 33% reduction in mean number of nocturnal voids over a three-month period compared to baseline. NOCDURNA was approved with a boxed warning because it can cause hyponatremia.1
NOCDURNA sublingual tablets dissolve rapidly with specific dosing designed for men and women, delivering a low and effective dose of desmopressin. Women are prescribed 27.7 mcg daily, while the dose for men is 55.3 mcg daily, administered sublingually without water one hour before bedtime.
Ferring Pharmaceuticals (US) CEO Paul Navarre said: “At Ferring, we are expanding our portfolio with novel treatments for diseases that impose significant burdens on patients.
“We are delighted to make NOCDURNA available to US healthcare providers and their patients today.”
Healthcare providers may call their local pharmacies to confirm that NOCDURNA is in stock. Adults who think they may be experiencing symptoms of nocturnal polyuria are encouraged to make an appointment with their healthcare provider to find out if NOCDURNA may be an appropriate treatment option.
NOCDURNA can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death. 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 the serum sodium concentration is normal before starting or resuming NOCDURNA.
Measure serum sodium within seven days and approximately one month after initiating therapy, and periodically during treatment.
Monitor serum sodium levels more frequently 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.
Source: Company Press Release