FDA Approves IncobotulinumtoxinA for Excessive Drooling in Adult Patients

Officials with the FDA have approved the supplemental Biologics License Application (sBLA) for incobotulinumtoxinA (Xeomin, Merz North America) for the treatment of chronic sialorrhea, a common symptom in patients with neurological disorders, according to a press release.

Chronic sialorrhea, or excessive drooling, can occur from difficulty retaining saliva inside the mouth, issues with swallowing, and from problems controlling facial muscles. It is a common symptom among patients with neurological disorders including Parkinson’s disease, amyotrophic lateral sclerosis, cerebral palsy, or who have experienced a stroke.

This approval makes incobotulinumtoxinA the first and only neurotoxin approved for this indication in the United States, according to the press release. IncobotulinumtoxinA is also approved to treat adults with cervical dystonia and blepharospasm in adult patients previously treated with onabotulinumtoxinA (Botox), as well as upper limb spasticity in adults. IncobotulinumtoxinA is administered by injection into the muscles or glands.

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