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Ferring Pharmaceuticals Release: New Study Showed Desmopressin Melt Reduced Sleep Disruption in Bedwetting Children


10/12/2012 7:26:16 AM

LONDON--(BUSINESS WIRE)-- Preliminary results from a new, prospective study presented today at the first Joint Congress of the International Children’s Continence Society (ICCS), Education and Resources for Improving Childhood Continence (ERIC), and the British Association of Paediatric Urology (BAPU) show that treatment with melt-in-the-mouth desmopressin (MINIRIN® Melt)*, an orally disintegrating tablet, reduced periodic limb movements (PLMS) in children with nocturnal enuresis (bedwetting).1 Periodic limb movements in sleep are repetitive movements, most typically in the lower limbs, that are associated with the disruption of normal sleep patterns2.

The preliminary results from the study of 30 children aged 6 – 16 years reveal that the anti-diuretic effect of desmopressin melt correlates strongly with reduced PLMS in children with nocturnal enuresis, as 90% of the children in the study experienced reduced PLMS.

This prospective study is on-going and has set out to evaluate the beneficial impact of desmopressin melt on sleep, cognition, quality of life and self-esteem, and other items. Full results are expected in 2013.

The children in the study had a diagnosis of nocturnal enuresis as identified by the ICCS criteria and had experienced at least four out of seven wet days with proven nocturnal polyuria (defined as nocturnal diuresis >100% bladder volume for age).

At initial screening, 87% of children were recorded as having disrupted sleep as measured by polysomnography (a recording of the biophysiological changes that occur during sleep). These children experienced more than 5 periodic limb movements per sleep hour (PLMS index). The overall PLMS index for those children involved in the study ranged between 3.6 and 23.3 (with a mean 10.8 +/- 5.0).

The six-month results show a significant improvement in the incidence of nocturnal enuresis (p<0.001) with 12 children recorded as being full responders to desmopressin melt treatment, 11 partial responders and only 5 non-responders. A reduction of the PLMS index was reported in 26 of 29 patients (90%, p<0.001) and a reduction of the nocturnal diuresis in 16 of 21 patients (76%, p=0.001).

Commenting on the results of the study, Johan Vande Walle, head of the Department of Pediatric Nephrology, University Hospital Ghent, Belgium explained: “This preliminary data suggests that by effectively treating bedwetting we can improve the quality of sleep, which is so important for a child’s development. As the study continues, we will explore the impact this brings to quality of life and daily functioning.”

* Desmopressin melt is indicated for the treatment of bedwetting in 72 countries across the world and it is marketed under several names, including Minirin® Melt and Desmomelt®

About Desmopressin:

In bedwetting, studies have shown that long-term treatment with desmopressin is effective, well tolerated and can aid long term improvements in nocturnal dryness.3,4 Therapy with the antidiuretic agent MINIRIN is a recommended first-line treatment for bedwetting with a level 1, grade A recommendation from the ICI and EAU/ESPU5,6. In addition, UK NICE guidelines, which are based on a review of evidence, suggest that treatment with desmopressin should be considered if rapid onset and/or short-term improvement in bedwetting is the priority of treatment or if an alarm is inappropriate or undesirable.7

When desmopressin is prescribed, patients should be instructed to avoid high fluid intake, not to ingest a higher than recommended dose and to promptly discontinue the medication and seek medical assessment if headache, nausea or vomiting develops. 8, 9

About Ferring Pharmaceuticals

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 and endocrinology. Ferring has its own operating subsidiaries in 50 countries and markets its products in more than 90 countries. To learn more about Ferring or its products please visit www.ferring.com.

1 Herzeele et al. Desmopressin improves sleep patterns in patients with nocturnal enuresis. ICCS 2012 Abstract (Poster Number 21)

2 Birgit Högl. Periodic Limb Movements are Associated With Disturbed Sleep. Journal of Clinical Sleep Medicine, Vol. 3, No. 1, 2007

3 Lottmann H, Baydala L, Eggert P, Klein BM, Evans J, Norgaard JP. Long-term desmopressin response in primary nocturnal enuresis: open-label, multinational study. Int J Clin Pract 2009;63(1):35-45

4 Evans J, Malmsten B, Maddocks A, Popli HS, Lottmann H; on behalf of the UK study group. Randomized comparison of long-term desmopressin and alarm treatment for bedwetting. J Pediatr Urol. 2011 Feb;7(1):21-9. Epub 2010 Jun 25.

5 Abrams P, Andersson KE, Birder L et al. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn 2010; 29(1):213-240.

6 Tekgül S, Riedmiller H, Gerharz E et al. Guidelines on Paediatric Urology. European Society of Paediatric

Urology/European Association of Urology, 2011. Available at http://www.uroweb.org/gls/pdf/21_Paediatric_Urology_LR%20[correctie%20Hoebeke].pdf Date Accessed 28th Sept 2012

7 National Institute for Clinical Guidance, reference guide: Nocturnal Enuresis: The management of bedwetting in children and young people. Available at http://www.nice.org.uk/nicemedia/live/13246/51382/51382.pdf Date Accessed 28th September 2012

8 Vande Walle J, Stockner M, Raes A, Norgaard JP. Desmopressin 30 Years in Clinical Use: A Safety Review. Curr Drug Saf. 2007 Sep;2(3):232-8.

9 Robson WL, Leung AK, Norgaard JP. The comparative safety of oral versus intranasal desmopressin for the treatment of children with nocturnal enuresis. J Urol. 2007 Jul;178(1):24-30.

Contact:

Moira Gitsham

Tonic Life Communications

Tel: +33 5 46 00 08 20

moira.gitsham@toniclc.com

or

Jim Baxter

Tonic Life Communications

Tel: +44 (0) 207 798 9918 / +44 (0) 7900 605 652

jim.baxter@toniclc.com

or

Patrick Gorman

Ferring Pharmaceuticals

Tel: +41 (0) 58 301 00 53

patrick.gorman@ferring.com


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