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Merz Neurosciences, a division of Merz North America, has announced positive topline results from its pivotal phase III clinical trial of Xeomin (incobotulinumtoxinA) for the treatment of adult sialorrhea, or unwanted drooling, due to Parkinson’s disease and other neurologic disorders during the 21st International Congress of Parkinson’s Disease and Movement Disorders (MDS) in Vancouver, BC.
Following the initial 16 week main period of the phase III, placebo-controlled, randomized, 184 patient trial, both co-primary endpoints were successfully achieved with statistically significant improvement observed in change in unstimulated salivary flow rate (uSFR) and in the patients’ Global Impression of Change Scale (GICS) at week four for patients administered 100U incobotulinumtoxinA as compared to baseline pre-injection 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. Patients enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).
“The findings from this well-controlled Phase III clinical study are a step towards providing a therapeutic option for adult patients with sialorrhea, a condition in which patient’s needs are not yet being met,” said Andrew Blitzer, M.D., D.D.S., coordinating investigator and professor of Clinical Otolaryngology at Columbia University College of Physicians and Surgeons. “Drooling is a burden to both patients and their caregivers. Importantly, the study results demonstrate a duration of efficacy and benefit beyond 4 months after the initial injection.”
Results of the study have been accepted by MDS in the Late-Breaking & Study Group Abstract Session. “We are excited to have achieved these results through the largest controlled study of incobotulinumtoxinA in the treatment of sialorrhea due to Parkinson’s disease and other neurological conditions,“ added David Dobrowski, VicePresident of Research and Development, Merz North America, Inc. “We look forward to discussing these data with the FDA as progress towards a future marketing application.”
SIAXI (Sialorrhea In Adults Xeomin Investigation) is a prospective, randomized, double-blind, placebo-controlled, phase 3 trial (NCT02091739) to investigate efficacy and safety of incobotulinumtoxinA for the treatment of unintended drooling, called sialorrhea, in Parkinson’s disease (PD) and other neurological conditions. Participants were adults (n=184) with chronic, troublesome sialorrhea related to PD, atypical Parkinson syndromes, stroke, or traumatic brain injury. In Merz North America.
Merz neurosciences, xeomin, sialorrhea
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