Randomized, Placebo-Controlled Trial of XEOMIN in Patients With Cervical Dystonia1,2
Change from baseline in the TWSTRS total score at week 4 after injection of the main period
TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale. TWSTRS total score includes subscales of Severity, Disability, and Pain.
Each patient received a single administration of 4.8 mL of reconstituted study agent (XEOMIN 240 units, XEOMIN 120 units, or placebo)1
The investigator at each site decided which muscles would receive injections of the study agent, the number of injection sites, and the volume at each site1
Most patients received a total of 2–10 injections into the selected muscles. Patients were assessed by telephone at 1 week post-injection, during clinic visits at weeks 4 and 8, and then by telephone assessments or clinic visits every 2 weeks up to week 201
The mean age of the study patients was 53 years, and 66% of the patients were women. At study baseline, 61% of patients had previously received a botulinum toxin as treatment for cervical dystonia. The study was completed by 94% of study patients. Three patients discontinued the study prematurely due to adverse events: two patients in the 240 unit group experienced musculoskeletal pain and muscle weakness, and one patient in the 120-unit group experienced nausea and dizziness.1
Randomized, Active-Controlled Noninferiority Trial of XEOMIN vs Botox® in Patients With Cervical Dystonia4
Change from baseline in the TWSTRS severity score after week 4
ITT, intention-to-treat; TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale. TWSTRS total score includes subscales of Severity, Disability, and Pain.
The potency Units of XEOMIN are specific to the preparation and assay method utilized. They are not interchangeable with the other preparations of botulinum toxin products and, therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.
XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use, is a prescription medicine that is used to treat adults with:
See full prescribing information for complete BOXED WARNING.
The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
The most commonly observed adverse reactions at rates specified below and greater than placebo are:
Chronic Sialorrhea: (≥4% of patients) tooth extraction, dry mouth, diarrhea, and hypertension.
Upper Limb Spasticity: (≥2% of patients) seizure, nasopharyngitis, dry mouth, upper respiratory tract infection.
Cervical Dystonia: (≥5% of patients) dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
Blepharospasm: (≥10% of patients) eyelid ptosis, dry eye, visual impairment, and dry mouth.
Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.
Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.
The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established.