Xeomin (incobotulinumtoxinA) has been approved by Health Canada to treat adults with chronic sialorrhea – excessive drooling – a condition often experienced by people with neurological conditions such as Parkinson’s disease.
“The reality is that uncontrolled cures are underestimated in many neurological diseases,” said Michel Panisset, MD, of the Center Hospitalier de l’Université de Montréal, Canada, in a press release. “Untreated untreated dololing or sialorrhea, is an unpleasant and unpleasant symptom that can have aesthetic, psychological and medical consequences in some patients.”
“Xeomin is very welcome as a treatment option for these patients with chronic sialorrhea,” added Panisset.
Excessive drooling is typically caused by difficulty controlling muscles in the face and mouth, which can make it difficult to swallow or retain saliva inside the mouth. In addition to Parkinson’s, chronic sialorrhea is common in people with amyotrophic lateral sclerosis (ALS) and cerebral palsy, and people who have had a stroke.
Xeomin, marketed by Merz Therapeutics, is a neurotoxin similar to that used in botox injections. Injected directly into the muscles and glands, it can block nerve cell signals that cause altered muscular responses, thereby reducing drooling.
In Canada, Xeomin is now the first and only license to treat excessive drooling. The medication for adults with chronic sialorrhea was approved in the US in 2018.
“Adults living with chronic sialorrhea have suffered from this debilitating condition without licensed neurotoxin treatment for long enough,” said Yannick Grosskreutz, Merz, Canada’s country manager. “Merz Therapeutics is passionate about developing better outcomes for more patients and this latest Xeomin milestone demonstrates that commitment especially to an estimated 65,000 Canadian adult patients suffering from chronic sialorrhea. ”
Health Canada’s approval of Xeomin was based on the results of a Phase 3 placebo-controlled clinical trial called SIAXI (NCT02091739), sponsored by Merz.
The study assessed the efficacy and safety of two different doses of Xeomin (75 or 100 Units), compared with placebo, in reducing saliva flow rate, and severity and frequency of chronic sialorrhea.
In total, 184 adults enrolled with excessive drooling, associated with parkinsonism, stroke, or traumatic brain injury.
Results at multiple time points showed that the higher dose of the medication significantly reduced the magnitude and frequency of unnecessary drooling, compared to pre-treated values and with placebo-treated participants.
At each dose, adverse events were similar in the Xeomin and placebo groups; the study did not identify any new safety concerns related to the medication.
“I am very encouraged by the clear published evidence that Xeomin reduces saliva flow rates in patients suffering from sialorrhea due to neurological conditions such as Parkinson’s disease and related disorders,” said Anthony Lang, MD, director of the Movement Disorders Program at University Health Network. in Toronto. “Based on the data and my own clinical experience in managing this challenging problem, Xeomin has an established tolerance and safety profile and is an important option for the treatment of chronic sialorrhea in adults.”
In Canada, Xeomin has previously been approved for the treatment of seventh nerve hypertrophic disorders such as blepharospasm, to reduce the symptoms and signs of cervical dystonia in adults, and to treat upper limb spasticity in adults .