Currently Enrolling Trials
Daxxify (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent.
Daxxify is specifically indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
Daxxify is supplied as an injection for intramuscular use. The total recommended dose is 40 Units per treatment session divided into five equal intramuscular injections of 8 Units each (two injections in each corrugator muscle and one injection in the procerus muscle).
Mechanism of Action
Daxxify (daxibotulinumtoxinA-lanm) blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine. When injected into skeletal muscle, Daxxify is internalized into the nerve terminal, translocates into the neuronal cytosol where it cleaves SNAP25, a protein necessary for synaptic vesicle membrane docking and subsequent release of acetylcholine which produces a dose dependent decrease of muscle function. Recovery of activity is gradual and results from the degradation of neurotoxin light chain in the neurons with a contribution from the formation of axonal sprouts. Muscle reinnervation occurs, leading to a slow reversal of the pharmacological effects of Daxxify.
Adverse effects associated with the use of Daxxify may include, but are not limited to, the following:
- eyelid ptosis
- facial paresis
The Daxxify drug label comes with the following Black Box Warning: The effects of Daxxify and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. Daxxify is not approved for the treatment of spasticity or any conditions other than glabellar lines.
Clinical Trial Results
The FDA approval of Daxxify was based on the SAKURA Phase 3 clinical trial program (SAKURA 1, 2, 3), which included more than 2,700 patients and approximately 4,200 treatments. In the pivotal trials:
- 74% of subjects achieved a > two-grade improvement in glabellar lines at week 4 per both investigator and patient assessment
- 88% achieved > two-grade improvement at week 4 per investigator assessment
- 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment
- The median duration of effect was 6-months
- Some patients maintained treatment results at 9 months
- Results seen as early as one day after treatment, typically seen within two days