IncobotulinumtoxinA (Xeomin} for the treatment of chronic sialorrhea, a common symptom in patients with neurological disorders.
Chronic sialorrhea, or excessive drooling, can occur from difficulty retaining saliva inside the mouth, issues with swallowing, and from problems controlling facial muscles.
Chronic sialorrhea is a common symptom among patients with neurological disorders including Parkinson’s disease, amyotrophic lateral sclerosis, cerebral palsy, or who have experienced a stroke.
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.
Administered by injection into the muscles or glands.
The approved indication is based on results from a phase 3 study including 184 patients, shoeing a statistically significant improvement in unstimulated salivary flow rate.
Overall, frequency of adverse effects was similar between placebo and treatment groups.
More than 600,000 adults suffer from chronic sialorrhea.