Ferring Canada Introduces NOCDURNA®, a New Treatment for Canadian Adults Suffering from Nocturia

TORONTO, Feb. 5, 2015 /CNW/ -- Ferring Canada, a subsidiary of Ferring Pharmaceuticals group, today announced the availability in Canada of NOCDURNA^® (desmopressin orally disintegrating tablets) for adult men and women who awaken up to four times nightly to urinate due to nocturia. Nocturia, a common and bothersome urological condition that equally affects both men and womenⁱ, is characterized by the repeated need to wake to urinate at night. Nocturia is one of the leading causes of poor sleep quality and affects more than 40 percent of Canadian adults between the ages of 40 and 65 and nearly half of the elderly population.^ii,iii

"The availability in pharmacies of NOCDURNA^®, the first low-dose format of desmopressin indicated in Canada for the treatment of nocturia in adults, expands treatment options for healthcare providers and is good news for patients for whom behavior and lifestyle changes have not been effective in reducing the frequency of waking up for nighttime urination," said Michael Seckler, General Manager, Ferring Canada.

Many factors can contribute to nocturia, such as underlying medical conditions like overactive bladder (OAB) and benign prostatic hyperplasia (BPH). However, people commonly experience nocturia due to nocturnal polyuria, which means a person makes a large amount of urine while asleep, although their total 24-hour production may remain normal.^iv In fact, nocturnal polyuria has been reported to be common in patients with OAB and BPH.^v,vi

"The ability to use a low dose format of desmopressin for nocturia will greatly enhance the treatment options that Canadian physicians can now consider," said Dr. Sender Herschorn, Professor, Division of Urology, University of Toronto, Sunnybrook Health Sciences Centre. "Nocturia is often due to a combination of nighttime urine overproduction and bladder storage problems. For some patients, medications like NOCDURNA^®, which targets the production of urine by the kidneys, may be beneficial to provide relief of their nighttime symptoms."

About NOCDURNA^®
NOCDURNA^® is an antidiuretic that contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin. It works by stimulating vasopressin receptors in the kidneys, causing increased water re-absorption and hence reduced urine production.

In Phase 3 clinical trials, NOCDURNA^® demonstrated consistent, significant efficacy by several measures that translated into clinical benefits for patients. These trials used co-primary efficacy endpoints of the average reduction in the number of times that patients urinated during the night as well as in the proportion of participants with more than 33 percent reduction in the average number of their nighttime urinations. The trials also assessed as a secondary endpoint the impact of NOCDURNA^® on the first period of undisturbed sleep, an outcome linked with better sleep quality and higher nocturia-related quality of life.

NOCDURNA^® is the first and only desmopressin with a gender-specific recommended dose in the treatment of adults with nocturia. The recommended dose of NOCDURNA^® is 25 micrograms (mcg) in women and 50 mcg in men one hour before bedtime. Use of NOCDURNA^® requires careful fluid restriction to prevent possible prolonged fluid retention and subsequent hyponatremia.

In Phase 3 pivotal trials, the most common adverse reactions seen with NOCDURNA^® were hyponatremia, dry mouth, diarrhea and headache. NOCDURNA^® is formulated and differentially dosed by gender to maintain efficacy while reducing the risk in elderly patients of hyponatremia, a decrease in the blood level of sodium.

About Nocturia
More than 40 percent of adults between the ages of 40 and 65 experience nocturia, according to the 2005 EPIC study surveying adults in Canada, Germany, Italy, Sweden, and the United Kingdom. Other studies report nocturia rates ranging from 29 to 59 percent in men older than 70 and 28 to 62 percent in women older than 70.^vii

Nocturia is a serious condition that can cause poor sleep quality, which leads to feeling tired, reduced quality of life, mood disturbance, thinking and memory impairment, and decreased work productivity.^viii Studies have related nocturia to increased rates of death, risks of falls, night sweats, and leg cramps and tingling.^ix

About Ferring
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries, employs 5,000 people throughout the world and markets its products in 110 countries.

Ferring Canada is the Canadian subsidiary of Ferring Pharmaceuticals. Ferring Canada started its operations in 1987 with just three employees. Today, Ferring Canada employs nearly 90 employees and sees considerable growth ahead as it continues to bring valuable new products to the Canadian marketplace. Ferring Canada's therapeutic focus is on urology, gastroenterology and reproductive health. Ferring Canada is committed to providing innovative medication that will help Canadians have an even better quality of life in the years to come.

To learn more about Ferring or its products, call 1-888-FERRING (1-888-337-7464) or visit www.ferring.ca.

© 2015 Ferring B.V.
NOCDURNA^® is a registered trademark of Ferring B.V.

ⁱ Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006;50:1306-1315.
ⁱⁱ Herschorn et al. BJU Int 2008 Jan;101:52-8; 2. Irwin et al. Eur Urol 2006;50:1306–1314.
ⁱⁱⁱ Tikkinen KA, Tammela TL, Huhtala H, Auvinen A, "Is nocturia equally common among men and women? A population based study in Finland." J Urol. 2006;175(2):596.
^iv Gormley, E. A., et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) In Adults: AUA/SUFU Guideline. J Urol. 2012 Dec;188(6 Suppl):2455-63. Epub 2012 Oct 24
^v Weiss JP et al. The New England Research Institutes, Inc. (NERI) Nocturia Advisory Conference 2012: focus on outcomes of therapy. BJU Int. 2013;111(5):700-16.
^vi Yoong HF et al. Prevalence of nocturnal polyuria in patients with benign prostatic hyperplasia. Med J Malaysia. 2005;60;294-296.
^vii Bosch JL, Weiss JP., The prevalence and causes of nocturia. J Urol. 2010 Aug;184(2):440-6. doi: 10.1016/j.juro.2010.04.011. Epub 2010 Jun 17
^viii Carskadon MA. Sleep deprivation: health consequences and societal impact. Med Clin North Am 2004; 88:767–776; Buysse DJ. Insomnia, depression, and aging: Assessing sleep and mood interactions in older adults. Geriatrics. 2004;59:47–52;  Newman AB, et. al. Daytime sleepiness predicts mortality and cardiovascular disease in older adults. J Am Geriatr Soc. 2000; 48:115–123; Dinges DF, et. al. Cumulative sleepiness, mood disturbance and psychomotor vigilance performance decrements during a week of sleep restricted to 4-5 hours per night. Sleep. 1997; 20:267–77; Ancoli-Israel S, Bliwise DL, Nørgaard JP. The effect of nocturia on sleep. Sleep Med Rev. 2011; 15:91–97.
^ix Laureanno, P., Ellsworth, P. Demystifying Nocturia: Identifying the Cause and Tailoring the Treatment. Urol Nurs. 2010;30(5):276-287.

SOURCE Ferring Pharmaceuticals

Christy Maginn, P: 202.530.4730, E: [email protected], http://www.ferring.ca