Xeomin filed with FDA for sialorrhea in Parkinsons disease.- Merz.

The FDA has accepted for filing a supplemental Biologics License Application (sBLA) for Xeomin (incobotulinumtoxinA), from Merz, for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson�s Disease or other neurologic disorders in adult patients. The sBLA is based on a Phase III study, which met both of its co-primary endpoints for subjects administered 100 U incobotulinumtoxinA by achieving statistically significant change in unstimulated salivary flow rate (uSFR), and in the subjects� Global Impression of Change Scale (GICS).

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in Q4 2018, and if approved, has the potential to make Xeomin the first neurotoxin with this indication in the U.S.

The sBLA is based on a Phase III, randomized, double-blind, placebo-controlled, multicenter 184 subject trial. Both co-primary endpoints were successfully achieved. A statistically significant improvement was observed in change in uSFR at week four as compared to baseline pre-injection, for subjects administered 100 U incobotulinumtoxinA vs. placebo, and in the subjects� GICS at week four for subjects administered 100 U incobotulinumtoxinA vs. placebo (p=0.004 and p=0.002, respectively). GICS is a commonly used rating system for treatments of neurological disorders by clinicians. 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).

Results of the study were presented at last year�s International Congress of Parkinson�s Disease and Movement Disorders, American Academy of Physical Medicine and Rehabilitation and American Congress of Rehabilitation Medicine annual meetings.