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Trial of Long-Acting Neuromodulator Yields Positive Phase 3 Results
The next-generation neuromodulator daxibotulinumtoxinA for injection (RT002, Revance Therapeutics, Inc.) delivered positive top-line results in alleviating moderate-to-severe glabellar lines in two pivotal phase 3 trials, the company announced. RT002 appeared generally safe and well tolerated in both studies.
If the FDA approves RT002, Revance believes it 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 trials—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 RT002-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% in SAKURA 1 and 74.0% in SAKURA 2 compared with placebo (P < 0.0001) at week 4. Also at that time point, 88% of RT002-treated patients in SAKURA 1 and 91% of RT002 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 RT002 compared with 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 RT002 to return to baseline wrinkle severity was nearly 27 weeks (SAKURA 1, 27.7 weeks; 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. Assuming successful completion of SAKURA 3, the company plans to submit a biologics license application in the first half of 2019 and, pending approval by the FDA, launch RT002 in the U.S. in 2020.
Treatment of glabellar lines is the most popular aesthetic procedure for an injectable neuromodulator, accounting for nearly a third of the $3.6 billion in global neuromodulator sales in 2016.
RT002 is also being studied for the treatment of cervical dystonia and plantar fasciitis.
Source: Revance; December 5, 2017.