Dr. Michael Gold discusses how the expected approval for long-lasting newcomer, DAXI, is pushing the envelope for current FDA-approved neurotoxins to examine higher doses.
“DAXI is changing a lot of things in the in the toxin space,” says Michael Gold, MD, FAAD. “DAXI will get an approval, most likely, for the longest acting toxin that we’ve had on the market.”
In his presentation, “What’s New and What’s Coming for Fillers and Toxins,” at Maui Derm 2021, Dr. Gold discussed the pending FDA approval of daxibotulinumtoxin A (DAXI; Revance) and how the product has already begun to influence dosing considerations for neurotoxins overall.
While most toxins are approved for a 12-week duration, DAXI is expected to receive approval for 24 weeks. In anticipation of this longer lasting duration, other brands are clinically testing higher doses for safety, efficacy, and patient satisfaction.
“Allergan, Galderma, [and] Merz have all done studies and are continuing to do studies looking at higher doses in the glabella to see what the duration is, and each one of them has now published at meetings or presented at meetings, their clinical findings,” says Dr. Gold.
Dr. Gold explains that the 20-unit, 12- to 16-week toxin benchmark was developed in early Botox trial design, against which other neurotoxin studies that followed have been measured.
“When toxins were developed—this is 20 plus years ago now—[dosing was approached as], what was the safest dose we can give people without causing any harm and for a reasonable amount of time duration. Three to four months became the go-to. If it lasted that long we were great,” he says.
Extended duration for DAXI is attributed to a positively charged excipient that Revance has added to its formulation.
DAXI is expected to come with a premium injection cost, as will higher doses of existing FDA-approved neurotoxins.
According to Dr. Gold, “This is a skill level. This is not your typical injection, and the adverse event profile in all these studies has been incredible.”
“Incredible,” he says, because seasoned injectors are conducting the studies.
“We’ve been doing toxin studies for 20 plus years. So, we have gotten to the point where we’re pretty good at doing this. And, you know, our comfort level with this kind of dosage is pretty high.”
