Results presented at 2018 AAPM&R Annual Assembly show long-term improvement in adult patients with chronic sialorrhea (or excessive drooling)
Merz today announced long-term results from a Phase 3 extension study of XEOMIN® (incobotulinumtoxinA) for the treatment of adults with chronic sialorrhea, also known as excessive drooling. Results were presented at the American Academy of Physical Medicine and Rehabilitation (AAPM&R) Annual Assembly being held October 25-28 in Orlando, FL.
In the randomized, placebo-controlled initial 16-week main period followed by a 48-week extension period, subjects who received XEOMIN demonstrated sustained improvements in unstimulated salivary flow rate (uSFR) across treatment cycles and increasing improvements in clinical outcomes and quality of life with repeated injection cycles. Overall results showed that safety and tolerability of XEOMIN was consistent across both study periods, and no new or unexpected adverse events were reported.
“The results from this pivotal extension period are significant for patients with neurological disorders, who often face a number of physical and psychosocial challenges due to chronic sialorrhea,” said Dr. Kristina Yu-Isenberg, Vice President, North America Medical Affairs at Merz. “We are pleased to share data confirming XEOMIN is safe and effective for long-term use in sialorrhea, as this can be a life-long challenge that patients and their physicians need to effectively manage to optimize outcomes.”
In July 2018, the U.S. Food and Drug Administration approved XEOMIN for the treatment of chronic sialorrhea in adult patients based on the pivotal study’s primary endpoint for the 16-week main period. XEOMIN is the first and only neurotoxin with this approved indication in the United States.
“We are pleased to offer the first and only neurotoxin for the estimated 600,000 adult patients living with chronic sialorrhea in the U.S.,” said Kevin O’Brien, Vice President and Head of U.S. Neurosciences, Merz. “This extension period, along with the two pooled safety analyses being presented reinforces the overall safety profile of XEOMIN in all of our indications, and further demonstrates our commitment to helping people living with movement disorders.”
SIAXI (Sialorrhea In Adults XEOMIN® Investigation) was a Phase 3, prospective, randomized, double-blind, placebo-controlled trial that investigated the efficacy and safety of XEOMIN for the treatment of excessive drooling (or sialorrhea).
In addition to the XEOMIN extension data being presented, Merz will be presenting two pooled safety analyses reinforcing the overall safety profile of XEOMIN in all of our indications:
• Pooled Safety Analysis of Randomized, Prospective Studies on IncobotulinumtoxinA for the Treatment of Cervical Dystonia, Blepharospasm, and Upper Limb Spasticity
• Safety of IncobotulinumtoxinA in Adult Spasticity: Results from a Pooled Analysis of Randomized, Prospective, Clinical Studies
https://www.merzusa.com/news/merz-presents-data-confirming-the-long-term-efficacy-and-safety-of-xeomin-incobotulinumtoxina-for-sialorrhea/