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NOCDURNA® (desmopressin acetate) Sublingual Tablets Now Available by Prescription in US for Treatment of Nocturia Due to Nocturnal Polyuria

November 9, 2018

PARSIPPANY, New Jersey--(BUSINESS WIRE)--Nov 9, 2018--Ferring Pharmaceuticals Inc. today announced the launch of NOCDURNA ® (desmopressin acetate), the first and only sublingual tablet approved in the United States for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least 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. 1

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NOCDURNA® (desmopressin acetate) Sublingual Tablets Now Available by Prescription in US for Treatment of Nocturia Due to Nocturnal Polyuria (Photo: Business Wire)

“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,” stated Jeffrey P. Weiss, MD, FACS, Professor and Chairman of Urology, State University of New York (SUNY) Downstate Medical Center. “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.

“At Ferring, we are expanding our portfolio with novel treatments for diseases that impose significant burdens on patients,” said Paul Navarre, CEO, Ferring Pharmaceuticals (US). “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. For more information, visit www.nocdurna.com.

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. 1

About NOCDURNA

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.

About Nocturia due to Nocturnal Polyuria

Nocturia is the need to awaken at night to urinate. It is a condition that affects more than 70 million people in the United States. 5 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. 6 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 (OAB) or benign prostatic hyperplasia (BPH). 4

About Ferring Pharmaceuticals

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. For more information, call 1-888-FERRING (1-888-337-7464); visit www.FerringUSA.com.

FERRING, the FERRING PHARMACEUTICALS logo, and NOCDURNA are trademarks of Ferring B.V.

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INDICATION

NOCDURNA is a vasopressin analog indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: HYPONATREMIA

See full Prescribing Information for complete boxed 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.

CONTRAINDICATIONS

Hyponatremia or a history of hyponatremia Polydipsia Concomitant use with loop diuretics or systemic or inhaled glucocorticoids Estimated glomerular filtration rate below 50 mL/min/1.73 m2 Syndrome of inappropriate antidiuretic hormone secretion (SIADH) During illnesses that can cause fluid or electrolyte imbalance Heart failure Uncontrolled hypertension

WARNINGS AND PRECAUTIONS

Limit fluid intake to a minimum from 1 hour before until 8 hours after administration. Treatment without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia. Fluid retention: Not recommended in patients at risk of increased intracranial pressure or history of urinary retention.

ADVERSE REACTIONS

Common adverse reactions (>2% incidence) included dry mouth, hyponatremia or blood sodium decreased, and dizziness.

DRUG INTERACTIONS

Monitor serum sodium more frequently when NOCDURNA is concomitantly used with drugs that may increase the risk of hyponatremia (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, thiazide diuretics, carbamazepine, lamotrigine, sulfonylureas, particularly chlorpropamide and NSAIDS).

USE IN SPECIFIC POPULATIONS

Pregnancy: Use of NOCDURNA is not recommended.

Geriatric Use: Increased risk of hyponatremia if 65 years of age or older. Monitor serum sodium more frequently.

To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-888-337-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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References:

1. NOCDURNA [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc.

2. Weiss JP, van Kerrebroeck PE, Klein BM, Nørgaard JP. Excessive nocturnal urine production is a major contributing factor to the etiology of nocturia. J Urol. 2011;186(4):1358-1363.

3. Weiss JP. Nocturia: focus on etiology and consequences. Rev Urol. 2012;14(3-4):48-55.

4. Weiss JP, Blaivas JG, Bliwise DL, et al. The evaluation and treatment of nocturia: a consensus statement. BJU Int. 2011;108(1):6-21.

5. Vaughan CP, et al. Differences in the association of nocturia and functional outcomes of sleep by age and gender: a cross‐sectional, population‐based study. Clin Ther. 2016;38(11):2386‐2393.

6. Van Kerrebroeck P, et al. Terminology, epidemiology, etiology, and pathophysiology of nocturia. Neurourol Urodyn. 2014;33:S2-S5.

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View source version on businesswire.com:https://www.businesswire.com/news/home/20181109005280/en/

CONTACT: Peter Dannenfelser

Associate Vice President, Communications & Digital Innovation

(973) 796-5135 (direct)

(973) 832-2304 (mobile)

peter.dannenfelser@ferring.com

or

Patrick Gorman

Director, External Communications

(862) 286-5035 (direct)

(973) 722-6335 (mobile)

patrick.gorman@ferring.com

KEYWORD: UNITED STATES NORTH AMERICA NEW JERSEY

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY PHARMACEUTICAL FDA

SOURCE: Ferring Pharmaceuticals

Copyright Business Wire 2018.

PUB: 11/09/2018 08:00 AM/DISC: 11/09/2018 08:00 AM

http://www.businesswire.com/news/home/20181109005280/en

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