Data from Pharmawand - Curated by EPG Health - Date added 06 December 2017
Revance Therapeutics, Inc. company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, announced its next-generation neuromodulator Daxibotulinumtoxin A for Injection (RT 002) delivered positive top-line results in alleviating moderate-to-severe glabellar lines in two pivotal SAKURA Phase III trial. RT 002 appeared generally safe and well-tolerated in both studies. If approved by the FDA, Revance believes RT 002 would be the first neuromodulator with a long-acting duration of six months. Marketed neuromodulators have demonstrated duration of three to four months in treating glabellar lines.
Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines, i.e., the frown lines or wrinkles between the brows. The percent of RT 002-treated patients who had none or mild wrinkles and achieved at least a two-point improvement from baseline on both validated physician and patient assessments were 73.6 percent in SAKURA 1 and 74.0 percent in SAKURA 2 compared to placebo (p < 0.0001) at Week 4. Also at that time point, 88 percent of RT 002-treated patients in SAKURA 1 and 91 percent of RT 002 patients in SAKURA 2 said they were very satisfied or satisfied with their treatment experience. All secondary endpoints measuring reduction in severity of glabellar lines with RT 002 compared to placebo were highly statistically significant at every time point evaluated to 24 weeks. On an additional key secondary endpoint, median duration for patients treated with RT 002 to return to baseline wrinkle severity was nearly 27 weeks (SAKURA 1: 27.7 weeks and SAKURA 2: 26.0 weeks) as assessed by both physicians and patients.
In addition to SAKURA 1 and SAKURA 2, a long-term safety trial, SAKURA 3, is fully enrolled and is expected to be completed in the second half of 2018.