RALEIGH, N.C., October 25, 2018
Results presented at 2018 AAPM&R Annual Assembly show long-term improvement in adult patients with chronic sialorrhea (or excessive drooling).
Merz 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.”
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