DaxibotulinumtoxinA Provides Clinically Meaningful Improvement of Cervical Dystonia in Phase 3 Trial

Results from a phase 3 clinical trial (NCT03608397) showed that treatmend of cervical dystonia with daxibotulinumtoxinA (Revance Therapeutics, Newark, CA) provided clinically meaningful and long-lasting relief of pain and reduction of disability. 

Individuals treated with daxibotulinumtoxinA 125 or 250 units had a dose-dependent improvement from baseline on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). Those treated with daxibotulinumtoxinA 125 or 250 U had improvements of 10.9 and 12.7 points on TWSTRS, respectively, compared with 4.3 points in those treated with placebo (P=0.0006 and P<0.0001, respectively).

The median duration of effect was 24.0 and 20.3 weeks for the 125U and 250U groups respectively, based on the median time to loss of 80% of the peak treatment effect, which is twice as long as what is typically seen with currently approved botunlinum toxin treatments. Injections of botulinum toxin are standard of care for cervical dystonia.   

“I was delighted to see both the degree and duration of relief that daxibotulinumtoxinA for Injection provided trial subjects in ASPEN-1,” said Joseph Jankovic, MD, Professor of Neurology, Distinguished Chair in Movement Disorders; Founder and Director, The Parkinson's Disease Center and Movement Disorders Clinic, Baylor College of Medicine. “Currently, most patients with cervical dystonia visit their physician 3 to 4 times a year for injections, which places a heavy burden on patients’ time and schedule. Often, the treatment effect wears off between injections, significantly impacting the quality of their work and personal lives. If a treatment could offer longer duration of effect, thus requiring fewer trips each year for reinjection, I imagine patients would find this quite beneficial.”

In this trial, participants with cervical dystonia were randomly assigned on 3:3:1 basis to receive a single treatment of either 125U or 250U of the therapy or placebo and were followed for up to 36 weeks. DaxibotulinumtoxinA was generally safe and well-tolerated at both doses.