FDA Approves XEOMIN® (incobotulinumtoxinA) for Adult Patients with Sialorrhea

First and only neurotoxin approved for this indication in the United States

RALEIGH, NC, USA I July 03, 2018 I Merz North America announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XEOMIN® (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. XEOMIN is the first and only neurotoxin with this approved indication in the U.S.

“Until now, there has not been an FDA approved treatment for this debilitating condition,” said Kevin O’Brien, Vice President and U.S. Head of Neurosciences, Merz North America. “This approval represents a significant milestone in addressing the unmet needs for more than 600,000 adults who suffer from chronic sialorrhea, and underscores our commitment to improving the lives of those living with movement disorders.”1,2,3,4,5,6

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.7,8 The condition can occur from difficulty retaining saliva inside the mouth, issues with swallowing and from problems controlling facial muscles.7,9

The FDA granted this application a priority review designation upon acceptance. Priority reviews are granted to drugs that will potentially provide significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions.

XEOMIN was approved by the FDA for adult patients with sialorrhea and is based on a Phase III, randomized, double-blind, placebo-controlled, multicenter 184 patient trial. Both co-primary endpoints were successfully achieved. A statistically significant improvement was observed in change in unstimulated salivary flow rate (uSFR) and 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). GICS is a commonly used rating system for treatments of neurological disorders by clinicians. Overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Subjects enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).

This is the fourth neurological indication for XEOMIN, which was first approved by the FDA in 2010 for the treatment of cervical dystonia and blepharospasm (in patients previously treated with onabotulinumtoxinA) in adult patients and later in 2015 for upper limb spasticity in adult patients.

About Merz Neurosciences

Merz Neurosciences is a division of Merz North America and is deeply committed to offering novel therapeutic options that address the largely unmet medical needs that exist within the area of neuroscience. Merz Neurosciences is an important contributor to the U.S. neurosciences space and offers a portfolio that includes the neurotoxin XEOMIN® (incobotulinumtoxinA), the anticholinergic Cuvposa® (glycopyrrolate) Oral Solution and the Prolaryn® injectable implant family of products. To learn more about Merz Neurosciences and its U.S. product portfolio, please visit www.merzusa.com/neurosciences. For more information about Merz Neurosciences and its U.S. product portfolio, please visit www.merzusa.com.

About Merz North America, Inc.

Merz North America, Inc. is a specialty healthcare company dedicated to the development and marketing of innovative quality products for physicians and patients across the United States and Canada. Merz products are distributed through two divisions, Aesthetics and Neurosciences, and are developed with the goal of improving patients’ health and quality of life by delivering therapies that bring about real progress. Privately-held, Merz North America is headquartered in Raleigh, North Carolina. To learn more about Merz North America, Inc., please visit www.merzusa.com.

About XEOMIN® (incobotulinumtoxinA)

XEOMIN® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles or glands and used to treat adults with sialorrhea, increased muscle stiffness in the arm of adults with upper limb spasticity, the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, and to treat abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox®).

XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION

Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

  • Talk to your health care provider or pharmacist
  • Visit www.xeomin.com to obtain the FDA-approved product labeling
  • Call 1-844-4MYMERZ

Uses

XEOMIN is a prescription medicine used in adults:

  • that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea).
  • that is injected into muscles and used to:
    • treat increased muscle stiffness in the arm because of upper limb spasticity.
    • treat the abnormal head position and neck pain with cervical dystonia (CD) in adults
    • who have and have not had prior treatment with botulinum toxin.
    • treat abnormal spasm of the eyelids (blepharospasm) in adults who have had prior
    • treatment with onabotulinumtoxinA (BOTOX®).

It is not known if XEOMIN is safe and effective in children under 18 years of age.

1. Kowal SL, et al. (2013) Mov Disord. 28(3): 311-318

2. Kalf et al. J Neurol 2009; 256(9):1391-6.

3. Prevalence and Most Common Causes of Disability Among Adults --- United States, 2005. (2009, May 1). Retrieved June 28, 2018, from https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5816a2.htm

4. Walshe M et al. Cochrane Database Syst Rev. 2012;14:11.

5. Tiigimäe-Saar J et al. (2017) Clin Oral Invest. 21: 795-800

6. “What Is ALS?” ALSA.org, www.alsa.org/news/public-awareness/als-awareness-month/2016/what-is-als.html.

7. Hockstein, NG, et al. “Sialorrhea: a Management Challenge.” American Family Physician Journal, 1 June 2004, pp. 2628–34. doi:https://www.ncbi.nlm.nih.gov/pubmed/15202698.

8. Dashtipour, Khashayar, et al. “RimabotulinumtoxinB in Sialorrhea: Systematic Review of Clinical Trials.” Journal of Clinical Movement Disorders, 6 June 2017, doi: 10.1186/s40734-017-0055-1.

9. Bavikatte, Ganesh, et al. “Management of Drooling of Saliva.” British Journal of Medical Practitioners, vol. 5, no. 1, Mar. 2012, www.bjmp.org/content/management-drooling-saliva.

SOURCE: Merz

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