German neurotoxin firm Merz has secured European approval for its Xeomin (incobotulinumtoxinA) for the symptomatic treatment of chronic sialorrhea (drooling) due to neurological disorders in adult patients.
Xeomin is claimed to be the first and only neurotoxin with this approved indication in the EU. It secured approval from the US Food and Drug Administration (FDA) in July 2018.
Sialorrhea is a common and undertreated symptom accompanying neurological conditions such as Parkinson’s disease, acquired brain injury, amyotrophic lateral sclerosis (ALS), cerebral palsy (CP) or stroke.
Xeomi is a purified neurotoxin type A (150kD) free from complexing proteins, which prevents the release of the neurotransmitter acetylcholine from nerve endings at muscles and salivary glands.
The prescription medicine is said to be used intramuscularly for the treatment of increased muscle stiffness. IncobotulinumtoxinA is a highly potent active ingredient.
The current approval was based on data from a phase III, randomized, double-blind, placebo-controlled and multicenter 184 patient trial.
According to the company, both co-primary endpoints were successfully achieved, including statistically significant improvement was observed in change in unstimulated salivary flow rate (uSFR) and Global Impression of Change Scale (GICS), both at week four as compared to baseline pre-injection for subjects administered 100 U incobotulinumtoxinA against placebo.
Xeomin was first launched in 2005 in Germany, and was approved in 13 EU member states in 2007 to treat cervical dystonia and blepharospasm in adult patients.
In 2009, Xeomin secured approval to treat upper limb spasticity in adult patients. It was also approved in 31 EU/EEA member states to treat different neurological indications and is registered in over 60 countries.
Merz EMEA region head and managing director Stefan Brinkmann said: “At Merz, we are committed to bringing more good days to patients living with severe neurological disorders.
“We are confident that this new treatment option can help improve quality of life for sialorrhea patients, as well as for their relatives and caregivers. In many European countries, an approved medication for sialorrhea treatment in adults has not been available before now.”