FDA approves Xeomin (incobotulinumtoxinA) for chronic sialorrhea


The FDA approves Xeomin (incobotulinumtoxinA) for chronic sialorrhea in children.

The Food and Drug Administration (FDA) approved Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea (drooling) in patients aged 2 years and older.1 In August, Xeomin had been approved for the treatment of upper limb spasticity. This is the first and only FDA-approved neuromodulator with this indication.2

The approval is based on 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 to 17 years.2 Xeomin is injected into the glands that make saliva and used to treat long-lasting chronic drooling which can occur in neurologically impaired children who have cerebral palsy or who have suffered a traumatic brain injury.1

Chronic sialorrhea can lead to a number of medical and psychosocial concerns, including chronic aspiration resulting in recurrent infections and progressive lung disease, skin irritation, and breakdown. Psychosocially it can damage books, computers, and toys, and cause social embarrassment, isolation, and low self-esteem in the patient.3

It is estimated that some 300,000 children in the United States have chronic sialorrhea. Noted Dr Elizabeth Moberg-Wolff, of Pediatric Rehabiliation Medicine Associates in Milwaukee, Wisconsin, "Having Xeomin approved to treat another symptom that children living with movement disorders experience is an important milestone for patients, caregivers, and health care providers."2

1.Food and Drug Administration.Highlights of prescribing information. Accessed December 21, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125360s073lbl.pdf

2.Food and Drug Administration (FDA) approved pediatric indication for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea. News release. Merz Therapeutics. December 21, 2020.

3.Nationwide Children's. Sialorrhea (excessive drooling). Accessed December 21, 2020. https://www.nationwidechildrens.org/conditions/sialorrhea

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