FDA approves Xeomin for chronic sialorrhea.- Merz.
The FDA has approved Xeomin (incobotulinumtoxinA), from Merz, for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients. This is the first drug therapy to be approved by the FDA to treat this condition. This approval is based on Phase III data showing a significant reduction in unstimulated salivary flow rate versus placebo.
The trials showed that the overall frequency of adverse events similar between placebo and treatment groups with no new or unexpected adverse events reported. Sialorrheam, or excessive drooling, is a common symptom among patients who suffer from neurological disorders including Parkinson's disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP) or who have experienced a stroke.
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