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XEOMIN® Efficacy - Cervical Dystonia

Adults With Cervical Dystonia

Disease
Overview
Clinical
Trials
Efficacy Safety Dosing

Proven Efficacy in Adults With Cervical Dystonia1,2

Pivotal Trial: XEOMIN vs Placebo

Demonstrated Improvements in Cervical Dystonia as Measured by the Primary Endpoint, the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)1,2*

Pivotal Study results

*Baseline was determined at visit 2 (day 0); visit 1 was initial screening visit. At week 4, there was no reduction in the TWSTRS total score for placebo

XEOMIN demonstrated no significant difference in effectiveness between doses2

The efficacy of XEOMIN was similar in patients who were botulinum toxin–naïve and those who had received botulinum toxin prior to this study2

Examination of age and gender subgroups did not identify differences in response to XEOMIN. There were too few African American patients to adequately assess efficacy in that population2

Noninferiority Study: XEOMIN vs Active Comparator (Botox®)

XEOMIN and Botox were similarly effective in treating the symptoms of cervical dystonia as measured by TWSTRS score at week 4. Similar improvements from baseline in TWSTRS severity score.3

Efficacy of XEOMIN vs Active Comparator (Botox®)

XEOMIN was proven noninferior to the active comparator (Botox) in adults with cervical dystonia3

The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.

XEOMIN and Botox had similar durations of effect in adults with cervical dystonia3

Chart displaying results of test subject results for the Duration of Effect In Patients

§Patient-reported outcome: onset and waning of effect were subjectively estimated by the patient at control and end of study visits.

In this non-inferiority study, investigator assessment of duration of effect was calculated based on the time between the initial injection and the end of study visit (return to 80% of baseline Toronto Western Spasmodic Torticollis Rating Scale Severity Score).

The duration of effect in patients with cervical dystonia was comparable between XEOMIN and Botox3

References

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2019.
  2. Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; US XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN®, botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011;308(1-2):103-109.
  3. Benecke R, Jost WH, Kanovsky P, Ruzicka E, Comes G, Grafe S. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurology. 2005;64(11):1949-1951.