Efficacy and safety of DaxibotulinumtoxinA in cervical dystonia

A recent study has shown that DaxibotulinumtoxinA (DAXI) is an effective and well-tolerated treatment for cervical dystonia (CD) when administered at doses of 125U and 250U. The study’s findings were published in the journal, Neurology.

ASPEN-1 was a phase 3 clinical trial that involved participants aged 18-80 years with moderate-to-severe CD. The study was randomized, double-blind, and placebo-controlled, with 301 participants receiving single-dose intramuscular DAXI 125U (n=125), 250U (n=130), or placebo (n=46). The change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score averaged across weeks 4 and 6 was the primary end point of this study, while duration of effect, Clinical and Patient Global Impression of Change (CGIC), (PGIC),TWSTRS subscale scores, and safety outcomes were the key secondary end points included.

DAXI 125U and 250U exhibited a substantial increase in the mean TWSTRS total score when compared to the placebo group (least squares mean [standard error] difference vs placebo: DAXI 125U, -8.5; DAXI 250U, -6.6). The median duration of effect with DAXI 125U was 24.0 weeks, while with DAXI 250U it was 20.3 weeks. Notable improvements were also seen in CGIC and PGIC responder rates, as well as TWSTRS subscales.

Therefore, it can be inferred that DAXI, administered at 125U and 250U dosages, could serve as an effective, long-acting, safe, and well-tolerated therapy for CD.