FDA approves neurotoxin for excessive drooling in adults

4 July 2018

The US Food and Drug Administration has approved the supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients.

German family-owned drugmaker Merz Pharma’s Xeomin is the first and only neurotoxin with this approved indication in the USA, according to the company.

“Until now, there has not been an FDA approved treatment for this debilitating condition,” said Kevin O’Brien, vice president and US head of Neurosciences, Merz North America. “This approval represents a significant milestone in addressing the unmet needs for more than 600,000 adults who suffer from chronic sialorrhea, and underscores our commitment to improving the lives of those living with movement disorders,” he added.

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