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)

Abstract

Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A in clinical development. Phase 2 data have shown it offers a more prolonged duration of response than onabotulinumtoxinA.

Objective: To further evaluate the efficacy, duration of response, and safety of 40 U DAXI compared with placebo in the treatment of glabellar lines.

Methods: Two identical, multicenter, randomized, double-blind, placebo-controlled, phase 3 studies were performed (NCT03014622 and NCT03014635 on www.clinicaltrials.gov). Participants with moderate or severe glabellar lines were randomly assigned (2:1) to receive 40 U DAXI or placebo into the corrugator/procerus muscles. Glabellar line severity was assessed by investigators and participants for up to 36 weeks (≥24 weeks).

Results: Among 609 participants enrolled (405 DAXI, 204 placebo), 92% completed. DAXI was significantly more effective than placebo in reducing glabellar line severity and maintained none or mild glabellar line severity for a median of 24.0 weeks. It was also generally well tolerated-treatment-related adverse effects were most commonly headache (6.4% vs 2.0%) and injection site pain (3.7% vs 3.9%).

Limitations: The study population was predominantly female and white and received only a single treatment.

Conclusions: DAXI offers a prolonged duration of response for glabellar line reduction and is well tolerated.

Keywords: DAXI; RT002; RTP004; aesthetic; botulinum toxin; daxibotulinumtoxinA; double-blind; duration; facial rejuvenation; glabellar lines; humans; injection; multicenter; neuromodulator; neuromuscular agent; peptide; phase 3; placebo; pooled; randomized.