EMA: Xeomin approved for treatment of chronic sialorrhea in adults
The European Commission has approved Xeomin ( IncobotulinumtoxinA ) for the symptomatic treatment of chronic sialorrhea due to neurological disorders in adult patients.
Xeomin is the first and only neurotoxin with this approved indication in the European Union, which follows the US FDA approval in July 2018.
Sialorrhea is a common but undertreated symptom accompanying neurological conditions such as Parkinson's disease, acquired brain injury, amyotrophic lateral sclerosis ( ALS ), cerebral palsy ( CP ) or stroke.
Patients who experience sialorrhea suffer from a negative impact on activities of daily living, as well as social stigma and impaired quality of life.
Left untreated, sialorrhea could be associated with perioral skin breakdown and pain around the mouth, choking, speech disorder, dehydration and aspiration pneumonia.
The approval of Xeomin for adult patients with sialorrhea by EMA ( European Medicines Agency ) is based on a phase III, randomized, double-blind, placebo-controlled, multicenter 184 patient trial.
Both co-primary endpoints were successfully achieved.
A 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 versus placebo ( p=0.004 and p=0.002, respectively ).
GICS is a commonly used rating system for treatments of neurological disorders by clinicians. Overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported.
Subjects enrolled in the study received placebo ( n=36 ), IncobotulinumtoxinA 75 U ( n=74 ), or IncobotulinumtoxinA 100 U ( n=74 ).
Xeomin is a purified neurotoxin type A ( 150kD ) free from complexing proteins that prevents the release of the neurotransmitter acetylcholine from nerve endings at muscles and salivary glands.
This prescription medicine is used intramuscularly to treat increased muscle stiffness, e.g. in the arm or shoulder of adults with upper limb spasticity, or abnormal head position that happens with cervical dystonia ( spasmodic torticollis ) in adults, and to treat abnormal spasm of the eyelids ( blepharospasm ).
The mode of action is similar in salivary glands by reducing saliva production after injection thereby reducing the frequency and severity of sialorrhea. ( Xagena )
Source: Merz Pharma, 2019
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