Aspen, Colo. — A new neuromodulator nearing the end of FDA Phase 3 development may last longer than existing options, attendees at the summer Cosmetic Bootcamp (CBC) learned.
DaxibotulinumtoxinA includes a positively charged peptide that binds with the negatively charged portion of its unique type A neuromodulator molecule. According to developer Revance, this combination may provide safer and longer-lasting treatments than existing neuromodulators can deliver.
Kenneth Beer, M.D., said, “Daxibotulinum has a very early response. Compared to the other toxins, even at 6 months, there’s still significant activity.”
At the final (week 24) follow-up visit in the pivotal SAKURA 1 and 2 trials, 35.3% and 29.4% of actively treated patients maintained investigator global assessment scores of zero or one for glabellar wrinkles. The most common treatment-related adverse event among daxibotulinum-treated patients was headache, which impacted 7% and 5.9% of patients, respectively.
Revance plans to complete its SAKURA 3 open-label, long-term safety study at the end of 2019. If daxibotulinum earns approval, Revance plans to launch the product in 2020.
Dr. Beer is associate clinical professor of dermatology at the University of Miami Miller School of Medicine, consulting associate with Duke University, clinical associate in dermatology, University of Pennsylvania Perelman School of Medicine and a CBC cofounder.
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