Randomized, Double-Blind, Placebo-Controlled Trial of XEOMIN in Treatment-Naïve Patients With Blepharospasm2
Change in Jankovic Rating Scale Severity Subscore after 6 weeks
*At the end of the initial 20-week placebo-controlled phase, patients had the option to enroll in an open-label extension if they had a confirmed need for a re-injection
†XEOMIN 25 units was not statistically significant when compared with placebo at week 6 (P=.1452)
Patients had a clinical diagnosis of blepharospasm, with a baseline Jankovic Rating Scale (JRS) severity subscore ≥2
Patients were defined as treatment-naïve if at least 12 months had passed since their last botulinum toxin treatment for blepharospasm
Of the 61 patients randomized, 55 patients completed the placebo-controlled phase. Patients only continued to the open-label extension (OLEX) period if they had a confirmed need for a re-injection by week 20 of the placebo-controlled phase. A total of 39 patients entered and completed the OLEX phase
During the placebo-controlled phase, a fixed total dose of XEOMIN 25 units (n=22), XEOMIN 50 units (n=19), or placebo (n=20) was administered intramuscularly at 6 injection sites per eye
The primary efficacy variable was the change from baseline in JRS Severity subscore determined at week 6 after the injection. The XEOMIN 50 Unit treatment group demonstrated statistically significant improvements compared to placebo, with a difference of -1.2 (P=0.0004). The change from baseline in the JRS Severity subscore for the XEOMIN 25 Unit treatment group 6 weeks after the injection was not statistically significant, with a difference of -0.5 (P=0.1452) compared to placebo
Randomized, Double-Blind, Placebo-Controlled Trial of XEOMIN in Patients With Blepharospasm Pretreated With Botox2
Change in JRS Severity subscore after 6 weeks
‡Placebo-controlled (main) period treatment individualized per patient; dosing, dilution, volume, and injection sites based on last 2 Botox treatments
Patients with any significant neuromuscular disease that might interfere with the study were excluded from enrollment. Patients were randomized (2:1) to receive a single dose of XEOMIN (n=75) or placebo (n=34). The mean age of the study patients was 63 years, and 65% of the patients were women2
The study was completed by 94% of study patients. Approximately one-third of patients had other dystonic phenomena; in all but 1% this was limited to facial, cervical, perioral, and mandibular muscles. No patients discontinued the study prematurely due to adverse events2
Randomized, Double-Blind, Active-Controlled Noninferiority Trial ofXEOMIN vs Botox in Patients with Blepharospasm3
Change in JRS after 3 weeks
§Subjects had the opportunity to come for optional visits whenever a need for injection was felt. Whenever a new injection was necessary, the final-visit evaluation was performed.
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.