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# FDA Accepts Merz sBLA for Parkinson’s Drooling
- URL: https://www.fdaweb.com/fda-accepts-merz-sbla-for-parkinsons-drooling/
- Published: 2018-03-14T12:00:00.000Z
- Updated: 2026-09-14T23:53:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5140983

FDA has accepted for review a Merz North America supplemental BLA for Xeomin (incobotulinumtoxinA) for treating chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients. The submission is based on a Phase 3 study, which Merz says met both of its co-primary endpoints by achieving statistically significant change in unstimulated salivary flow rate and in the subjects’ “Global Impression of Change Scale.” Overall adverse event frequency was similar between placebo and treatment groups with no new or unexpected adverse events reported, the company says. The agency has set a user fee review action target for the fourth quarter.