XEOMIN® Efficacy | Cervical Dystonia

Adults With Cervical Dystonia

Pivotal trial: XEOMIN vs placebo

Both Doses of XEOMIN Significantly Improved Cervical Dystonia Symptoms vs Placebo1,2

  • Demonstrated improvements in cervical dystonia as measured by the primary endpoint, the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)1,2
Pivotal Study Results for Cervical Dystonia Pinch to zoom

*Baseline was determined at visit 2 (day 0); visit 1 was initial screening visit.
P<0.001.

  • 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 Was Proven Noninferior to the Active Comparator (Botox) in Adults With Cervical Dystonia3

  • XEOMIN and Botox were similarly effective in treating the symptoms of cervical dystonia as measured by TWSTRS severity score at week 43
Efficacy of XEOMIN® vs Active Comparator (Botox®) Pinch to zoom

‡Per-protocol population.
§P<0.0001.

  • 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.
Chart displaying results of test subject results for the Duration of Effect In Patients Pinch to zoom

‖Time to onset of effect was the time from injection until start of treatment effect, the time to waning of effect was the time from injection until decline of effect, and the duration of effect was the interval between injection and the first visit at which the TWSTRS severity score had reached at least 80% of the baseline value.

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, Kañovský 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.