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.
- IncobotulinumtoxinA Efficacy / Safety in Upper-Limb Spasticity in Pediatric Cerebral Palsy: Randomized Controlled Trial, Dabrowski, Pediatric Neurology
- IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study, Heinen, Journal of Pediatric Rehabilitation Medicine, Cerebral Palsy Issue
*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:
XEOMIN is a prescription medicine:
It is not known if XEOMIN is safe and effective in children younger than:
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:
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:
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:
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:
The most common side effects of XEOMIN in adults with chronic sialorrhea include:
The most common side effects of XEOMIN in children 2 to 17 years of age with chronic sialorrhea include:
The most common side effects of XEOMIN in adults with upper limb spasticity include:
The most common side effects of XEOMIN in children 2 to 17 years of age with upper limb spasticity include:
The most common side effects of XEOMIN in adults with cervical dystonia include:
The most common side effects of XEOMIN in adults with blepharospasm include:
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
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For more information, please see the XEOMIN full Prescribing Information and Medication Guide at www.xeomin.com.