DaxibotulinumtoxinA Injection Provides Longer Duration of Treatment for Cervical Dystonia

In the ASPEN-1 phase 3 clinical trial (NCT03608397) of daxibotulinumtoxinA (Daxi; Revance Therapeutics, Nashville, TN) for the treatment of cervical dystonia in adults was found effective. Improvement was measured as mean change from baseline in the Toronto Western Spasmodic Torticollis Rating Scale–severity (TWSTRS) total score at the average of weeks 4 and 6 and was seen with doses of 125 U and 250 U. The time to loss of 80% of peak benefit was 24 weeks, which could increase the average time between doses significantly, allow individuals clinical benefit with as much as 50% fewer injections per year. 

Lead investigator Dr. Joseph Jankovic, Department of Neurology, Baylor College of Medicine, Houston, TX, noted that considerable and prolonged relief from the pain and awkward disabilities associated with CD could offer an improved quality of life for patients suffering from this debilitating movement disorder. Additionally, a drug with a longer duration potentially translates to less frequent needles placed in people’s’ neck, also contributing to a reduced burden of disease. 

“We’re pleased to present the efficacy and safety findings from the ASPEN-1 phase 3 clinical trial evaluating daxibotulinumtoxinA at this year’s 2021 AAN Virtual Meeting, specifically, the median duration of effect of up to 24 weeks, as determined by time to loss of 80% peak treatment benefit said Roman Rubio, senior vice president of Clinical Development at Revance. “The findings being presented are part of a growing body of clinical evidence that supports daxibotulinumtoxinA differentiated performance profile and underscores the potential of our therapeutics pipeline for the treatment of muscle movement and pain disorders for patients who suffer from these debilitating conditions.” 

In the ASPEN-1trial, participants were randomized to a single treatment of either 125 Unit or 250 Unit dose daxibotulinumtoxinA or placebo for a maximum of 36 weeks. Duration of treatment effect, measurement of treatment response on the Clinical and Patient Global Impression of Change assessments, and adverse events were observed. In the ASPEN-OLS study, participants receive up to 4 sequential treatment cycles of daxibotulinumtoxinA over a 52-week observation period. Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with DAXI. The ASPEN-OLS trial is fully enrolled with a total of 354 participants. 

These data are being presented at the 2021 American Academy of Neurology (AAN) Virtual Annual Meeting on April 17 - 22, 2021.