IncobotulinumtoxinA is the first and only neurotoxin approved for this indication in the United States.
Officials with the FDA have approved the supplemental Biologics License Application (sBLA) for incobotulinumtoxinA (Xeomin, Merz North America) for the treatment of chronic sialorrhea, a common symptom in patients with neurological disorders, according to a press release.
Chronic sialorrhea, or excessive drooling, can occur from difficulty retaining saliva inside the mouth, issues with swallowing, and from problems controlling facial muscles. It is a common symptom among patients with neurological disorders including Parkinson’s disease, amyotrophic lateral sclerosis, cerebral palsy, or who have experienced a stroke.
This approval makes incobotulinumtoxinA the first and only neurotoxin approved for this indication in the United States, according to the press release. IncobotulinumtoxinA is also approved to treat adults with cervical dystonia and blepharospasm in adult patients previously treated with onabotulinumtoxinA (Botox), as well as upper limb spasticity in adults. IncobotulinumtoxinA is administered by injection into the muscles or glands.
The approved indication is based on results from a phase 3 study including 184 patients, in which both co-primary endpoints were successfully achieved. In the study, patients received either a placebo, incobotulinumtoxinA, or incobotulinumtoxinA 100 U.
According to the data, a statistically significant improvement was observed in change in unstimulated salivary flow rate and Global Impression of Change Scale (GICS), a commonly used rating system for treatments of neurological disorders, at week 4 compared with baseline pre-injection.
Overall, frequency of adverse effects was similar between placebo and treatment groups with no new or unexpected events reported.
“Until now, there has not been an FDA approved treatment for this debilitating condition,” Kevin O’Brien, vice president and US Head of Neurosciences for Merz North America, said in the press release. “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.”
FDA Approves XEOMIN (InabotulinumtoxinA) for Adult Patients with Sialorrhea [news release]. Raleigh. Merz’s website. https://bit.ly/2KSH6aD. Accessed July 5, 2018.