Phase III studies of DAXI in glabellar lines published in JAAD.- Revance Therapeutics

Revance Therapeutics announced the publication of the pooled data from two multicenter, randomized, double-blind, placebo-controlled Phase III studies (SAKURA 1 and SAKURA 2) evaluating Revance�s long-acting neuromodulator product, DaxibotulinumtoxinA for Injection (DAXI) for the treatment of moderate to severe glabellar (frown) lines. The pooled results were published in the Journal of the American Academy of Dermatology (JAAD). The SAKURA 1 and SAKURA 2 studies were identical in design and evaluated the safety and efficacy of a single administration of DAXI.

The data showed that the primary endpoint of a 2-point composite response at week 4 was achieved in 73.8% of patients in the pooled DAXI group versus 0.5% in the pooled placebo group (p<0.0001 difference of 73.5 95 ci: 69.277.9. the proportion of responders to daxi was similar regardless of whether baseline glabellar line severity had been moderate 75.4 or severe 71.2.>

The pooled results were consistent with the findings from the earlier dose-ranging Phase 2 BELMONT study which demonstrated that DAXI for injection offers high response rates in the treatment of glabellar lines with a median duration of response of 24 weeks. Among 609 subjects enrolled in both SAKURA 1 and SAKURA 2, pooled data showed DAXI was significantly more effective than placebo in reducing glabellar line severity and subjects maintained none or mild glabellar line severity for a median of 24 weeks. DAXI was also generally well tolerated and no new safety signals were observed.

See: "DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)" Vince Bertucci et al. Journal of the American Academy of Dermatology November 15, 2019 https://doi.org/10.1016/j.jaad.2019.06.1313