Xeomin (incobotulinumtoxinA) has been approved by the U.S. Food and Drug Administration to treat chronic sialorrhea, or excessive drooling, a condition often experienced by people with cerebral palsy.
Merz Neurosciences, a division of Merz North America, announced that its supplemental biologics license application (sLBA) for Xeomin was granted FDA approval to treat adults with sialorrhea, making it the only approved neurotoxin for this indication in the U.S.
Approval came under a priority review by the FDA, a status is given to therapies with the potential to significantly improve the safety or effectiveness of treatment, diagnosis, or prevention of serious conditions.
“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 at Merz North America, said in press release.
Sialorrhea is a common symptom of neurological disorders that include amyotrophic lateral sclerosis (ALS), Parkinson’s disease, cerebral palsy, and can be common in stroke patients.
Difficulty in retaining saliva inside the mouth can stem form problems with swallowing or controlling facial muscles.
Xeomin is injected directly into muscles and glands, and can block nerve cell signals that cause altered muscular responses.
The FDA decision to approve Xeomin for sialorrhea was based on results from the randomized, double-blind, and placebo-controlled Phase 3 SIAXI clinical trial (NCT02091739).
The study assessed 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.
A total of 184 adult patients with Parkinson’s disease, traumatic brain injury, and other neurological conditions were randomized to either 75 or 100 units of Xeomin, or a placebo. Each treatment consisted of once weekly injections of the compound in the parotid and submandibular glands.
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 to measure change during treatment of neurological disorders.
These improvements were observed during the fourth week of treatment in patients give 100 units of Xeomin versus placebo, compared with the study’s beginning.
In general, the treatment was safe and the frequency of adverse events was similar between placebo and treatment groups. No new safety issues were reported.
Xeomin was previously approved to treat adults with abnormal head position and neck pain due to involuntary contraction of neck muscles, with abnormal spasm of the eyelids (blepharospasm) who were previously treated with Botox (onabotulinumtoxinA), and to reduce upper limb muscle stiffness (spasticity).