Xeomin (incobotulinumtoxinA) has been approved by the U.S. Food and Drug Administration to treat adults with chronic sialorrhea, or excessive drooling, a condition often experienced by Parkinson’s disease patients.
Merz Neurosciences, a division of Merz North America, announced that its supplemental biologics license application 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 priority review by the FDA, a status given to therapies with the potential to significantly improve the safety or effectiveness of treatment, diagnosis, or prevention of serious conditions.
“Until now, there has not been an FDA approved treatment for this debilitating condition,” Kevin O’Brien, vice president and U.S. head of neurosciences at Merz North America, said in a 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.”
Excessive drooling occurs in 50-80 percent of Parkinson’s patients, especially in men, and can lead to consequences such as social isolation and embarrassment. Patients with other neurological conditions, such as cerebral palsy or those who have had a stroke, may also have this disorder, which is most commonly caused by poor oral and facial muscle control. Excessive production of saliva and postural problems are other possible causes.
Xeomin is injected directly into muscles and glands, and can block nerve cell signals that cause altered muscular responses.
Its approval was based on results from the randomized, double-blind, 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 adults with excessive drooling associated with parkinsonism, stroke, or traumatic brain injury received either 75 Units (U) or 100 U of Xeomin, or a placebo.
Compared with pre-treatment assessments and with placebo, 100 U of Xeomin significantly reduced the unstimulated salivary flow rate (uSFR) and the severity and frequency of excessive drooling — as assessed by the Global Impression of Change Scale (GICS), routinely used in studies of neurological disorders — at four weeks.
The frequency of adverse events was similar between placebo and Xeomin at both doses, and no new or unexpected adverse events were reported.
Merz had already reported that both doses improved uSFR and GICS at weeks eight, 12, and 16 of treatment. Other analyses, including the Drooling Severity and Frequency Scale, confirmed the effectiveness of both treatment regimens.
Xeomin was previously approved to treat adults with abnormal head position and neck pain due to involuntary contraction of neck muscles, abnormal spasm of the eyelids (blepharospasm) in patients who were previously treated with Botox (onabotulinumtoxinA), and to reduce upper limb spasticity, or muscle stiffness.