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XEOMIN® (INCOBOTULINUMTOXINA) SAFETY AND EFFICACY DATA FOR TREATMENT OF PEDIATRIC CHRONIC SIALORRHEA PUBLISHED IN NEUROLOGY

  • Study demonstrated XEOMIN was safe and effective for the treatment of patients aged 2 to 17 years with chronic sialorrhea, or drooling
  • XEOMIN showed significant and sustained reduction of salivary flow, and no substantial waning of effect up to four months after injection
  • Two additional XEOMIN pediatric spasticity studies also published in Pediatric Neurology and Journal of Pediatric Rehabilitation Medicine

Merz Therapeutics announced today the online publication of the article “SIPEXI: Placebo-controlled clinical trial of incobotulinumtoxinA for sialorrhea in children” in Neurology, the premier peer-reviewed journal for clinical neurology research. Results from the Phase 3 study demonstrated the safety and sustained efficacy of XEOMIN® (incobotulinumtoxinA) for the treatment of patients aged 2 years and older with chronic sialorrhea, or drooling. This study data was used to support FDA-approval in the United States for this indication.

“The SIPEXI data reinforce XEOMIN’s sustained effectiveness in treating chronic sialorrhea in pediatric patients living with this debilitating condition,” said Rebecca McKinnon, PhD., Senior Director, U.S. Medical Affairs, Merz Therapeutics. “With our singular focus on meeting the needs of the movement disorder community, Merz Therapeutics continues its commitment to advancing new indications for XEOMIN through research and development efforts that aim to help patients have better symptom control.”

SIPEXI (Sialorrhea Pediatric Xeomin Investigation) was a Phase 3 prospective, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of XEOMIN in 255 children and adolescents aged 2 – 17 years. The study duration was 64 weeks, with a 16-week main period followed by three additional injections during a 48-week open label extension period. The co-primary endpoints among patients aged 6 ‒ 17 years were defined as the change in unstimulated Salivary Flow Rate (uSFR) from baseline to Week 4 and the Global Impression of Change Scale (GICS) score from baseline to Week 4, representing the functional improvement in drooling, as assessed by the caregiver.

In the study, both co-primary efficacy endpoints were met, demonstrating XEOMIN’s effectiveness and tolerability in the treatment of chronic sialorrhea. Patients aged 6-17 experienced notably reduced uSFR and improved GICS versus placebo, and sustained efficacy from repeated XEOMIN treatments was observed during the OLEX period (64 weeks). The decrease in uSFR was accompanied by improvements in other indicators, including GICS ratings at additional time points, modified Teacher’s drooling scale (mTDS) ratings and drooling quotients (DQs). Efficacy and safety were also comparable among the cohort of patients ages 2 ‒ 5 years. Among patients tested for neutralizing antibodies, none developed new neutralizing antibodies as a result of therapy, and there was no evidence of clinical resistance or secondary treatment failure in any patients.

“The results from the study established XEOMIN’s safety and efficacy in treating pediatric patients with chronic sialorrhea,” said coordinating study investigator Prof. Dr. Steffen Berweck*, Deputy Head Physician, Specialist Center for Pediatric Neurology, Neurorehabilitation and Epileptology at Schön Klinik. “Further, in several patients, there was no substantial waning of XEOMIN’s effect seen up to four months after injection, which supports the notion that a regimen of three treatments a year may work for some patients.”

Additionally, two other XEOMIN pediatric spasticity studies were recently published in Pediatric Neurology and the Journal of Pediatric Rehabilitation Medicine Cerebral Palsy Issue. Direct links to these online manuscripts are below.

Additional Publications

  • IncobotulinumtoxinA Efficacy / Safety in Upper-Limb Spasticity in Pediatric Cerebral Palsy: Randomized Controlled Trial, Dabrowski, Pediatric Neurology
XEOMIN is approved in the U.S. for use in pediatric patients with upper limb spasticity, excluding spasticity caused by cerebral palsy. These published manuscripts do not suggest or imply approved use for other spasticity indications in the U.S.

 

*Dr. Steffen Berweck is a paid consultant for Merz Pharmaceuticals GmbH.

 

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 (1-844-469-6379)
Uses 

XEOMIN is a prescription medicine:

  • that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea) in adults and in children 2 to 17 years of age.
  • that is injected into muscles and used to:
    • treat increased muscle stiffness in the arm because of upper limb spasticity in adults.
    • treat increased muscle stiffness in the arm in children 2 to 17 years of age with upper limb spasticity, excluding spasticity caused by cerebral palsy.
    • treat the abnormal head position and neck pain with cervical dystonia (CD) in adults.
    • treat abnormal spasm of the eyelids (blepharospasm) in adults.

It is not known if XEOMIN is safe and effective in children younger than:

  • 2 years of age for the treatment of chronic sialorrhea
  • 2 years of age for the treatment of upper limb spasticity
  • 18 years of age for the treatment of cervical dystonia or blepharospasm
Warnings

XEOMIN may cause serious side effects that can be life threatening.  Get medical help right away if you have any of these problems any time (hours to weeks) after injection of XEOMIN:

  • Problems swallowing, speaking, or breathing can happen if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
    • People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
    • Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.
  • Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN (see below for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport®) or have a skin infection at the planned injection site.

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:

  • have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome)
  • have had any side effect from any other botulinum toxin in the past
  • have a breathing problem, such as asthma or emphysema
  • have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
  • have drooping eyelids
  • have had eye surgery
  • have had surgery on your face
  • are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.  Talk to your doctor before you take any new medicines after you receive XEOMIN.

Using XEOMIN with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past.

Especially tell your doctor if you:

  • have received any other botulinum toxin product in the last four months
  • have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past.  Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.
  • have recently received an antibiotic by injection or inhalation
  • take muscle relaxants
  • take an allergy or cold medicine
  • take a sleep medicine

Ask your doctor if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Possible Side Effects

 XEOMIN can cause serious side effects including:

  • Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive XEOMIN to treat spasm of the eyelid may have reduced blinking that can cause a sore on their cornea or other problems of the cornea. Call your healthcare provider or get medical care right away if you have eye pain or irritation after treatment with XEOMIN.
  • XEOMIN may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint.  Tell your doctor or get medical help right away if you get wheezing or trouble breathing, or if you get dizzy or faint.

The most common side effects of XEOMIN in adults with chronic sialorrhea include:

·     needing to have a tooth pulled (extracted)

·     dry mouth

·        diarrhea

·        high blood pressure

The most common side effects of XEOMIN in children 2 to 17 years of age with chronic sialorrhea include:

·     bronchitis

·     nausea

·        headache

·        vomiting

The most common side effects of XEOMIN in adults with upper limb spasticity include:

  • seizure
  • nasal congestion, sore throat and runny nose
  • dry mouth
  • upper respiratory infection

The most common side effects of XEOMIN in children 2 to 17 years of age with upper limb spasticity include:

  • nasal congestion, sore throat and runny nose
  • bronchitis

The most common side effects of XEOMIN in adults with cervical dystonia include:

  • difficulty swallowing
  • neck pain
  • muscle weakness
  • pain at the injection site
  • muscle and bone pain

The most common side effects of XEOMIN in adults with blepharospasm include:

  • drooping of the eyelid
  • dry eye
  • vision problems
  • dry mouth

These are not all the possible side effects of XEOMIN.

Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of XEOMIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.

Active Ingredient: botulinum toxin type A

Inactive Ingredients: human albumin and sucrose


Copyright © 2021 Merz Pharmaceuticals, LLC. All rights reserved. MERZ, the MERZ logo, and

XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. Botox, Dysport and

Myobloc are registered trademarks of their respective owners.

For more information, please see the XEOMIN full Prescribing Information and Medication Guide at www.xeomin.com.

Press Contact

Jane Yarbrough
Corporate Communications
Merz Therapeutics
Merz Pharmaceuticals, LLC
6601 Six Forks Road, Suite 430
Raleigh, NC 27615

 

(984) 218-0983
Jane.Yarbrough@merz.com


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.