Xeomin (incobotulinumtoxinA) has been approved by the U.S. Food and Drug Administration for the treatment of chronic sialorrhea, or excessive drooling, a common condition in amyotrophic lateral sclerosis (ALS) patients.
Merz Neurosciences, a division of Merz North America, recently announced that its supplemental biologics license application (sBLA) for Xeomin was granted FDA approval for the treatment of adults with sialorrhea, making it the only approved neurotoxin for this indication in the U.S.
Merz Neurosciences’ sLBA application was granted priority review status by the FDA. This status is given to therapeutic products that have the potential to significantly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
Patients diagnosed with progressively deteriorating neurological diseases, such as ALS, frequently experience sialorrhea, due to difficulties with voluntary facial muscle control and swallowing.
“Until now, there has not been an FDA approved treatment for this debilitating condition. 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,” Kevin O’Brien, vice president and U.S. head of neurosciences for Merz North America, said in a press release.
Xeomin’s approval for sialorrhea was based on results from the randomized, double-blind, placebo-controlled, multicenter Phase 3 SIAXI clinical trial (NCT02091739).
The study aimed to assess the effectiveness and safety of two different doses of Xeomin, compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic sialorrhea.
It enrolled 184 participants who were randomized to receive a placebo (36 patients), a 75U dose of Xeomin (74 patients), or a 100U dose of Xeomin (74 patients).
Results showed that the trial met both of its primary objectives — a statistically significant improvement in unstimulated salivary flow rate and in the Global Impression of Change Scale, a commonly used rating system for treatments of neurological disorders. These improvements were observed during the fourth week of treatment in patients administered 100U of Xeomin versus placebo, compared with baseline, or the starting point of the study.
No significant difference in the number of adverse events was observed between placebo and treatment groups. There were also no new or unexpected adverse events reported during the study.
Xeomin was first approved by the FDA in 2010 for the treatment of adults with cervical dystonia and blepharospasm (in patients previously treated with onabotulinumtoxinA) and later in 2015 for upper limb spasticity.
This approval is the fourth indication for Xeomin to treat neurological conditions.