FDA okayed the first treatment for chronic sialorrhea, or excessive drooling, in adult patients.
The agency cleared the supplemental Biologics License Application (sBLA) for incobotulinumtoxinA (Xeomin, Merz North America), the first and only neurotoxin with this approved indication in the US, according to Merz.
“We are excited about the FDA’s approval of Xeomin for chronic sialorrhea, as this represents a significant milestone in addressing a condition that affects more than 600,000 adults in the U.S. In the past, sialorrhea has been difficult to treat often requiring a comprehensive treatment plan; this approval may help provide a more simplified treatment option,” Kevin O’Brien, vice president and US head of neurosciences for Merz North America, told FormularyWatch.
O’Brien said the wholesale acquisition cost is not yet available. The drug, however, is available immediately.
Sialorrhea is a common symptom among patients who suffer from neurological disorders including Parkinson's disease, amyotrophic lateral sclerosis (ALS), and cerebral palsy (CP), as well as those who have experienced a stroke.
FDA granted this application a priority review designation upon acceptance. Xeomin, first approved by FDA in 2010 for the treatment of cervical dystonia and blepharospasm (in patients previously treated with onabotulinumtoxinA) in adult patients, now has 4 neurological indications.
FDA’s approval of Xeomin sialorrhea is based on a phase 3, randomized, double-blind, trial of 184 patients. A statistically significant improvement was observed in change in unstimulated salivary flow rate (uSFR) and Global Impression of Change Scale (GICS), both at week 4 as compared to baseline pre-injection for subjects administered 100 U incobotulinumtoxinA versus placebo.
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