13 November 2018 - - Swiss specialty biopharmaceutical group Ferring Pharmaceuticals Inc. has launched Nocdurna (desmopressin acetate), the first and only sublingual tablet approved in the United States for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void, the company said.

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.

Nocdurna received approval from the US Food and Drug Administration on June 21, 2018 based on three double-blind placebo-controlled, multi-center, randomised 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.

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.

Nocdurna is the first and only sublingual tablet indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void.

Nocturia is the need to awaken at night to urinate. It is a condition that affects more than 70 m people in the United States.

Many urologic and non-urologic factors can cause nocturia, but the most common underlying cause is nocturnal polyuria, a disease of the kidneys marked by insufficient production of hormone called nocturnal vasopressin.

Nocturnal polyuria is present in up to 88% of nocturia patients. It occurs when a person's kidneys produce too much urine at night, causing the need to wake two or more times to urinate. Nocturnal polyuria can exist alone, or it can be commonly found in patients with overactive bladder or benign prostatic hyperplasia.

Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of reproductive health, women's health, urology, gastroenterology, endocrinology and orthopaedics.