Xeomin Approved in Canada to Treat Excessive Drooling, Common in Parkinson’s

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 like Parkinson’s disease.

“The reality is that uncontrolled salivation is underestimated in many neurological diseases,” Michel Panisset, MD, of the Centre hospitalier de l’Université de Montréal, in Canada, said in a press release. “Left untreated, involuntary drooling or sialorrhea is an annoying and disturbing symptom that can have aesthetic, psychological and medical consequences in some patients.”

“Having Xeomin as a treatment option for these patients with chronic sialorrhea is very welcomed,” Panisset added.

Excessive drooling is typically caused by difficulty controlling muscles in the face and mouth, which can make it difficult to swallow or to keep saliva inside the mouth. In addition to Parkinson’s, chronic sialorrhea is common among 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 what is used in botox injections. Injected directly into 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 neurotoxin licensed to treat excessive drooling. The medication was approved for adults with chronic sialorrhea in the U.S. in 2018.

“Adults living with chronic sialorrhea have suffered from this debilitating condition without a licensed neurotoxin treatment long enough,” said Yannick Grosskreutz, Merz’s country manager, Canada. “Merz Therapeutics is passionate about developing better outcomes for more patients and this latest Xeomin milestone demonstrates that commitment especially to Canada’s estimated 65,000 adult patients who suffer from chronic sialorrhea.”

Health Canada’s approval of Xeomin was based on the results of a placebo-controlled, Phase 3 clinical trial called SIAXI (NCT02091739), which was sponsored by Merz.

The study assessed the effectiveness and safety of two different doses of Xeomin (75 or 100 Units), compared with a placebo, in reducing the salivary flow rate, and the severity and frequency of chronic sialorrhea.

In all, it enrolled 184 adults with excessive drooling, associated with parkinsonism, stroke, or traumatic brain injury.

Results at multiple time points demonstrated that the higher dose of the medication significantly reduced the extent and frequency of unwanted drooling, relative both to values prior to being treated and to placebo-treated participants.

At all doses, 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 demonstrating Xeomin reduces salivary 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 tolerability and safety profile and is an important option for treating chronic sialorrhea in adults.”

In Canada, Xeomin has previously been approved to treat hypertonicity disorders of the seventh nerve such as blepharospasm, to reduce the symptoms and signs of cervical dystonia in adults, and to treat upper limb spasticity associated with stroke in adults.