Sialorrhea is a common symptom in patients with neurological conditions such as Parkinson’s disease, ALS, cerebral palsy, or in patients who have experienced a stroke.
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for incobotulinumtoxin A (XEOMIN) for the treatment of chronic sialorrhea, or excessive drooling, in adults.
With the approval, incobotulinumtoxin A becomes the first and only marketed neurotoxin in the US for this indication.
Sialorrhea is a common symptom in patients with neurological conditions such as Parkinson’s disease, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP), or in patients who have experienced a stroke. When patients suffer from swallowing and facial muscle control issues, their ability to retain saliva insider their mouth can be compromised.
The application was granted a priority review designation upon its acceptance, indicating a potential to provide significant safety and efficacy improvements in care. The therapy was approved based on the results of a phase 3, randomized, double-blind, placebo-controlled trial involving 184 patients from multiple health centers
In patients administered 100 units of incobotulinumtoxin A versus placebo, researchers observed a statistically significant improvement in unstimulated salivary flow rate (uSFR) and Global Impression of Change Scale (GICS) at week 4 compared to baseline pre-injection (P = 0.004 and P = 0.002, respectively).
Overall adverse event frequency was similar between placebo and treatment groups, with no unexpected events reported.
Kevin O’Brien, vice president and US head of Neurosciences for Merz North America, noted the benchmark achievement of the company’s XEOMIN in a statement.
“This approval represents a significant milestone in addressing the unmet needs for more than 600,000 adults who suffer from chronic sialorrhea, and underscores our commitment to improving the lives of those living with movement disorders,” O’Brien said.
The approval becomes the fourth neurological indication for XEOMIN, having been previously approved by the FDA for cervical dystonia, blepharospasm, and upper limb spasticity in adult patients.
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