Long Shot: Daxxify Shows Promise

The FDA recently approved Daxxify (daxibotulinumtoxinA-lanm) from Revance for the temporary improvement of moderate to severe glabellar lines in adults. Daxxify is the first and only neuromodulator stabilized with Peptide Exchange Technology (PXT) and is free of both human serum albumin and animal-based components.

“The beauty of Daxxify is that for all of our patients who have experience with other neuromodulators there is nothing different that they need to do or know that is different,” says Charles Boyd MD, a facial plastic and reconstructive surgeon and assistant professor of dermatology and otolaryngology at the University of Michigan in Detroit and Ann Arbor, MI. “For those patients who are new or have no experience with neuromodulators, Daxxify will give them a smooth, relaxed, extremely long-lasting result.”

Dr. Boyd was initially skeptical that Daxxify would be different from the other neuromodulators on the market. “What surprised me first was the results that my patients were receiving,” he says. “They looked natural, lifted and had zero safety issues. It wasn’t until later, after following the patients for several months, that I observed the longevity that a single treatment afforded them. I am excited to offer Daxxify to my patients.”

Patients before (top) and 6 months (bottom) after Daxxify (daxibotulinumtoxinA-lanm) injection.
(Photos courtesy of Revance.)

The pre- and post-injection advice for patients with Daxxify is no different than with other neurotoxins, says Marina Peredo, MD, the founder of Skinfluence Medical PC and an associate clinical professor in the department of dermatology Mount Sinai School of Medicine in New York City. “We recommend that there are no rashes or infections of the area treated pre-injection, and we recommend not to lay down, bend over, or workout for 2 hours post-injection.”

The approval of Daxxify was based on the data from the SAKURA Phase 3 clinical trial program, which included more than 2700 adults who received roughly 4200 treatments.

About three quarters of participants achieved at least a 2-grade improvement in glabellar lines at week 4 as judged by both investigator and patient, and 98% achieved “none or mild wrinkle severity” at week 4 per investigator assessment, the company reported. The median duration of treatment effect was 6 months, with some patients maintaining treatment results at 9 months, compared with a 3- to 4-month duration of treatment effect with conventional neuromodulators. (See photos above for before and after results of patients treated with Daxxify in the SAKURA Phase 3 Trial.)

Dr. Peredo’s site enrolled 50 patients with moderate to severe wrinkles in the glabella area. Patients received 40 units of Daxxify, which contained 0.18ng of core active neurotoxin. This amount is equal to the amount of core active neurotoxin in a 20U Botox Cosmetic dose (0.18ng).

“Our patients were very satisfied with the results they saw post treatment, and in most patients treated the results lasted for 6 months,” she says.

“Overall, our patients in the SAKURA trial reported high satisfaction rates and, as the Physician investigator, I loved the product and the results I saw. I can’t wait to start using it on my patients.”