Health Canada Licenses XEOMIN® (incobotulinumtoxinA) for Adult Patients With Sialorrhea

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Health Canada Licenses XEOMIN® (incobotulinumtoxinA) for Adult Patients With Sialorrhea


BURLINGTON, Ontario–(BUSINESS WIRE)–Merz Therapeutics today announced Health Canada’s notice of compliance for XEOMIN® (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, associated with neurological disorders in adult patients. XEOMIN is the first and only neurotoxin with this licensed indication in Canada.1

Adults living with chronic sialorrhea have suffered from this debilitating condition without a licensed neurotoxin treatment long enough,” said Yannick Grosskreutz, Country Manager, Canada for Merz Therapeutics. “Merz Therapeutics is passionate about developing better outcomes for more patients and this latest XEOMIN milestone demonstrates that commitment especially to Canada’s estimated 65,000 adult patients who suffer from chronic sialorrhea.”2-7

Sialorrhea is a common symptom among patients who suffer from neurological disorders including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP) or who have experienced a stroke.8,9 The condition can occur from difficulty retaining saliva inside the mouth, issues with swallowing and from problems controlling facial muscles.9,10

The reality is that uncontrolled salivation is underestimated in many neurological diseases,” said Dr. Michel Panisset of the Centre hospitalier de l’Université de Montréal. “Left untreated, involuntary drooling or sialorrhea is an annoying and disturbing symptom that can have aesthetic, psychological and medical consequences in some patients. Having XEOMIN as a treatment option for these patients with chronic sialorrhea is very welcomed.”

XEOMIN was licensed by Health Canada for adult patients with sialorrhea on the basis of a Phase III, randomized, double-blind, placebo-controlled, multicenter trial in which 184 patients participated.1,11 Both co-primary endpoints were successfully achieved.1,11 A statistically significant improvement was observed in change in unstimulated salivary flow rate (uSFR) as well as in Global Impression of Change Scale (GICS), both at week four as compared to baseline pre-injection for subjects administered 100 U incobotulinumtoxinA vs. placebo (p=0.004 and p=0.002, respectively).1,11 Overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported.1,11 Subjects enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).1,11 This Phase III study was followed by an open-label extension study where the efficacy and safety of XEOMIN were confirmed.12

I am very encouraged by the clear published evidence demonstrating XEOMIN reduces salivary flow rates in patients suffering from sialorrhea due to neurological conditions such as Parkinson’s disease and related disorders,” said Dr. Anthony Lang, Director of the Movement Disorders Program at University Health Network in Toronto. “Based on the data and my own clinical experience in managing this challenging problem, XEOMIN has an established tolerability and safety profile and is an important option for treating chronic sialorrhea in adults.”

This is the fourth therapeutic indication for XEOMIN in Canada, which was first licensed by Health Canada in 2009 for the treatment hypertonicity disorders of the seventh nerve such as blepharospasm, including benign essential blepharospasm and hemifacial spasm in adults, to reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults, and for the treatment of upper limb spasticity associated with stroke in adults.1

About Merz Therapeutics

At Merz Therapeutics, we seek to address the unique needs of people who suffer from movement disorders, neurological conditions, and other health conditions that severely impact patients’ quality of life. With our patient-centric approach, cutting-edge research and development efforts, highly-scientific medical affairs resources and dedicated commercial teams, we continue the advancement of new and individualized treatment standards, including botulinum toxin. Merz Therapeutics, a business of Merz Pharmaceuticals GmbH, is headquartered in Frankfurt, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Pharmaceuticals GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated more than 110 years to developing innovations that serve unmet patient and customer needs.

About XEOMIN® (incobotulinumtoxinA)

XEOMIN® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles or glands and used to treat adults with chronic drooling (sialorrhea), eyelid spasm (blepharospasm) and spasm in one side of the face (hemifacial spasm), twisted neck (spasmodic torticollis) and to treat uncontrollable muscle stiffness and/or muscle tone in arms or hands after a stroke (post-stroke spasticity of the upper limb).

Copyright © 2020 Merz Pharma Canada Ltd. All rights reserved. MERZ, the MERZ logo, and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA.

For more information, please see the XEOMIN® full Product Monograph.

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1. XEOMIN® Product Monograph. Merz Pharma Canada Ltd. November 17, 2020.

2. Government of Canada and Neurological Health Charities Canada. Mapping Connections: An understanding of neurological conditions in Canada. Ottawa (ON): Public Health Agency of Canada; 2014, Report No.: 140100.

3. Bray GM, Huggett DL. Neurological Diseases, Disorders and Injuries in Canada: Highlights of a National Study. Can J Neurol Sci. 2016 Jan;43(1):5-14.

4. Kalf JG, de Swart BJ, Borm GF, Bloem BR, Munneke M. Prevalence and definition of drooling in Parkinson’s disease: a systematic review. J Neurol. 2009 Sep;256(9):1391-6.

5. Wong SL, Gilmour H, Ramage-Morin PL. Parkinson’s disease: Prevalence, diagnosis and impact. Health Rep. 2014 Nov;25(11):10-4.

6. “Autonomic Dysfunction” in Canadian Guidelines for Parkinson Disease, 2nd edition, Parkinson Canada 2019.

7. “Management of Saliva and Drooling” Parkinson.ca (2017). Retrieved November 17, 2020, from https://parkinsonca.thedev.ca/wp-content/uploads/Management-of-Saliva-and-Drooling.pdf.

8. Hockstein, NG, et al. “Sialorrhea: a Management Challenge.” American Family Physician Journal, 1 June 2004, pp. 2628–34.

9. Dashtipour, Khashayar, et al. “RimabotulinumtoxinB in Sialorrhea: Systematic Review of Clinical Trials.” Journal of Clinical Movement Disorders, 6 June 2017.

10. Bavikatte, Ganesh, et al. “Management of Drooling of Saliva.” British Journal of Medical Practitioners, vol. 5, no. 1, Mar. 2012.

11. Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A, Ochudlo S, Banach M, Pagan F, Flatau-Baqué B, Csikós J, Cairney CJ, Blitzer A. SIAXI: Placebo-controlled, randomized, double-blind study of incobotulinumtoxinA for sialorrhea. Neurology. 2019 Apr 23;92(17):e1982-e1991.

12. Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A, Ochudlo S, Banach M, Pagan F, Flatau-Baqué B, Dorsch U, Csikós J, Blitzer A. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism Relat Disord. 2020 Jan;70:23-30.



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