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DaxibotulinumtoxinA shows greater efficacy, response duration vs. Botox
Injectable daxibotulinumtoxinA, an investigational botulinum toxin Type A, showed superior efficacy and duration of response in certain doses over Botox and placebo at treating glabellar lines, according to study results published in Dermatologic Surgery.
Jean Carruthers, MD, of the department of ophthalmology and visual sciences, University of British Columbia, Vancouver, Canada, and colleagues conducted a phase 2, dose-ranging, double-blind, multicenter study at nine private settings in Canada.
The study included 268 patients with moderate-to-severe glabellar lines during maximum frown (mean age range, 47-50 years; 76%-92% women) who were randomly assigned treatment of 20 U (n = 34 patients), 40 U (n = 39) or 60 U (n = 41) daxibotulinumtoxinA (Revance Therapeutics), 20 U (n = 42) Botox (onabotulinumtoxinA, Allergan) or placebo (n = 42).
Investigators and patients measured glabellar line severity at least every 4 weeks for at least 24 weeks. Treatment and study period was Dec. 23, 2014, to Dec. 1, 2015.
Proportion of patients with at least a 1-point improvement in the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) score at maximum frown was 100% in all daxibotulinumtoxinA treatment cohorts, 95% in the onabotulinumtoxinA cohort and 3% in the placebo cohort at week 4 (P < .001 for all botulinum toxin treatments vs. placebo). At week 24, 18%, 36% and 29% in the 20 U, 40 U and 60 U daxibotulinumtoxinA cohorts, respectively, as well as 19% in the onabotulinumtoxinA cohort and 3% in the placebo cohort had at least a 1-point improvement (P < .05 for all botulinum toxin treatments vs. placebo).
The three treatment arms of daxibotulinumtoxinA had a longer median duration of response (20.0, 23.6 and 20.9 weeks for the 20 U, 40 U, 60 U doses, respectively) compared with 20 U onabotulinumtoxinA (18.8 weeks) or placebo (0 weeks; P < .001 for all botulinum toxin groups vs. placebo).
In all doses, daxibotulinumtoxinA was generally well tolerated with no serious adverse events, except for a possible migraine in one patient in the 20 U dose group.
The researchers concluded the 40 U dose of daxibotulinumtoxinA had the most favorable risk/benefit profile, exhibiting a significantly greater response rate and significantly longer duration of response that the 20 U onabotulinumtoxinA treatment (P = .03) and will be evaluated in phase 3 studies.
“Injectable daxibotulinumtoxinA could represent the first of a new generation of botulinum toxin treatments, offering an enhanced duration of response without compromising safety or tolerability,” the researchers wrote. “Although onabotulinumtoxinA — the gold standard neuromodulator — has been fully justified in developing an enviable reputation globally, daxibotulinumtoxinA deserves very careful study, as it is currently the only new neuromodulator to challenge both the quality and duration of response of onabotulinumtoxinA.” – by Bruce Thiel
Disclosure: The study was sponsored Revance Therapeutics. Carruthers reports being a consultant and research for Revance, Allergan, Merz and Alphaeon. Please see the full study for a list of the other researchers’ relevant financial disclosures.