IncobotulinumtoxinA Approved for Treatment of Excessive Drooling
The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for incobotulinumtoxin A (Xeomin; Merz, Raleigh, NC) for the treatment of chronic sialorrhea, or excessive drooling, in adult patients. Incobotulinumtoxin A is the first and only neurotoxin approved to treat excessive drooling in the US.
“Until now, there has not been an FDA approved treatment for this debilitating condition,” said Kevin O’Brien, Vice President and U.S. Head of Neurosciences, Merz North America. “This approval represents a significant milestone in addressing the unmet needs for >600,000 adults who suffer from chronic sialorrhea, . . .”
The FDA granted this application a priority review designation upon acceptance. Priority reviews are granted to drugs that will potentially provide significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions.
Incobotulinumtoxin A is now approved for 4 different conditions in adults: cervical dystonia, blepharospasm, upper limb spasticity and excessive drooling. The FDA approval for the new indication of excessive drooling was based on data from a phase 3, randomized, double-blind, placebo-controlled, multicenter trial of 184 subjects. In patients given iconoboutlinumtoxin A, there were statistically significant improvements in unstimulated salivary flow rate (uSFR) and Global Impression of Change Scale (GICS), at week 4 vs. placebo (P = 0.004 and P = 0.002, respectively). The overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Subjects enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).