The FDA Has Finally Approved the Long-Lasting Wrinkle Relaxer DAXXIFY


We’ve been waiting for this news for some time. For what seemed like eternity the new neurotoxin DAXXIFY (it’s been referred to as DAXI before) has been pending FDA approval and because of COVID-related timing delays it has taken some time for the longer lasting injectable to go through the process. However, the day has finally come and Revance’s DAXXIFY wrinkle-relaxing injection has finally been approved for severe frown lines in the glabella area.

“We are very pleased DAXXIFY’s label includes data demonstrating the achievement of none or mild wrinkle severity based on investigator and subject assessments, as this provides the foundation for our marketing claims around duration of effect,” says Revance’s chief executive officer Mark J. Foley. “We look forward to continuing to set new standards in aesthetics and to establishing a new category of long-lasting, peptide-enhanced neuromodulators.”

What Sets It Apart

The biggest differentiator between DAXXIFY and the other neurotoxins on the market—Botox Cosmetic, Xeomin, Dysport and Jeuveau—is the length of time the product works to freeze muscle movement and smooth away lines and wrinkles. In clinical trials, DAXXIFY was shown to last six months or more, and sometimes up to nine months in some patients, making it the first FDA-approved neurotoxin that lasts longer than the standard three to five month duration.

“I have not had the opportunity to test DAXXIFY yet but I’m encouraged by their data in terms of longevity of the product,” says Wayne, NJ facial plastic surgeon Jeffrey B. Wise, MD. “It has the potential to be a significant game changer.”

The formula for DAXXIFY includes a stabilizing “Peptide Exchange Technology” that is associated with the increased longevity. In phase 3 of the clinical trials, the majority of patients noted a six-month median duration. Suffice it to say, we are beyond excited about the prospect of fewer expert injector visits (think twice a year) to keep lines and wrinkles at bay.

What It Means for Patients

For Boca Raton, FL oculoplastic surgeon Steven Fagien, MD the injectable is right on time as far as meeting the needs of the market. “Over the years and after performing thousands of neurotoxin treatments for facial cosmetic enhancement, a common comment from patients that are universally happy with their result is that they ‘wish the effects lasted longer,’” he shares. “The approval of DAXXIFY is a major step towards meeting patient’s desires and expectations.”

Also excited is New York dermatologist Doris Day, MD who says the full benefit of having a longer lasting option is better longterm line-smoothing results. “If I have a product that lasts longer, I can have more consistent results over time because there is less time where the effect has worn down or worn off between treatments,” she explains. “It’s also good to have more options for treatments for my patients.”