DaxibotulinumtoxinA-lanm (Daxxify(tm)): A Comprehensive Overview

Abstract and Introduction

Abstract

Botulinum toxin A (BoNTA) is produced by Clostridium botulinum and widely used for aesthetic indications requiring neuromuscular blockade. For dynamic facial lines, BoNTA is effective and safe, but also temporary, requiring repeat injections approximately every 3–4 months for maintenance of effects. There is a desire by both patients and providers for a longer-lasting neurotoxin to prevent periods of suboptimal correction. Approved by the US Food and Drug Administration (FDA) in September 2022, daxibotulinumtoxinA for injection (DAXI or Daxxify™) is the first long-lasting BoNTA formulated with a 150-kDa BoNTA (RTT150) and proprietary stabilizing excipient peptide (RTP004) in place of human serum albumin. DAXI is approved for treatment of moderate to severe glabellar lines. The median duration of effect was 6 months and results lasted as long as 9 months in some patients. Its unique formulation and prolonged effectiveness positions DAXI as a safe, novel BoNTA for improved durability and patient satisfaction.

Introduction

Botulinum toxin type A (BoNTA) is derived from Clostridium botulinum and has a variety of medical and aesthetic indications. BoNTA has been widely used in the United States (US) and Canada for the treatment of dynamic rhytids since its initial Food and Drug Administration (FDA) approval for glabellar lines in 1989. BoNTA inhibits muscle contraction by blocking neurotransmitter release in the neuromuscular junction, preventing formation of deep facial lines. This blockade is not permanent, necessitating repeat injections every 3–4 months to maintain the aesthetic benefit. Patient surveys have identified a desire for longer-lasting neuromodulators to reduce periods of suboptimal correction.^[1]

DaxibotulinumtoxinA-lanm for intramuscular use (DAXI or Daxxify™) is a novel peptide-formulated BoNTA engineered with a proprietary stabilizing excipient peptide (RTP004) in place of human serum albumin (HSA). On September 8, 2022, the US FDA approved DAXI as the first and only long-acting neuromodulator for the treatment of glabellar lines with a median duration of 6 months and up to 9 months for some patients.^[2] Its innovative formulation, prolonged durability, and overall performance has caused excitement among early practitioners for DAXI's potential in the realm of BoNTA treatment.

Table 1. Comparison of characteristics of BoNTA used for aesthetic injection in the United States.
	Injectable Cosmetic Neuromodulators
Generic name	DaxibotulinumtoxinA	OnabotulinumtoxinA	AbobotulinumtoxinA	IncobotulinumtoxinA	PrabotulinumtoxinA
Brand name	Daxi, Daxxify	Botox	Dysport	Xeomin	Jeuveau
Manufacturer	Revance Therapeutics	Allergan Pharmaceuticals	Ipsen Biopharm	Merz Pharma	Evolus
Packaging (U/vial)	100	100	500	100	100
Constituents and excipients	• RTP004 • Polysorbate-20 • Sugar • Buffer	• Hemaglutinin and nonhemaglutin proteins • HSA, 500 μg • Saccharose • NaCl	• Hemaglutinin and nonhemaglutin proteins • HSA, 125 μg • Lactose	• HSA, 1 mg • Saccharose	• HSA • NaCl
Molecular weight, kDa	150	900	500–900	150	900
Preparation	Lyophilized	Vacuum-drying	Lyophilized	Lyophilized	Vacuum-drying
Storage prior to reconstitution	Room temperature	2°C to 8°C	2°C to 8°C	Room temperature	2°C to 8°C
Shelf-life once reconstituted	72 hours	36 hours	24 hours	36 hours	24 hours
Median duration	6 months	3–4 months	4 months	3 months	1 month