PracticalDermatology

The FDA has approved Revance Therapeutics, Inc.’s Daxxify (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severe glabellar lines in adults. Daxxify, the first and only neuromodulator stabilized with Peptide Exchange Technology (PXT) and free of both human serum albumin and animal-based components, has the ability to address duration of treatment effect.

Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill and clinical trial investigator, says it’s this duration of action that makes Daxxify special, noting that median duration of action between 6 to 9 months of effect is something virtually unseen with other neuromodulators.

The US approval of Daxxify was based on data from 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 ≥2-grade improvement in glabellar lines at week 4 per both investigator and patient assessment
• 88% achieved ≥2-grade improvement at week 4 per investigator assessment
• 98% of subjects achieved none or mild wrinkle severity at week 4 per investigator assessment
• 6-month median duration
• Some patients maintained treatment results at 9 months
• Results seen as early as 1 day after treatment, typically seen within 2 days

 Daxxify is generally safe and well tolerated with no serious treatment-related adverse events reported in the clinical trials and has a safety profile consistent with other currently available neuromodulators in the aesthetics market. The most common treatment-related adverse events with Daxxify observed in the pivotal trials were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry (1%).

“Daxxify has actually addressed a need that’s gone unmet now for several decades. All the new neuromodulators that have been developed over the time since Botox came to the market years ago are similar, if not almost identical to Botox. What makes Daxi special is a median duration of action of 6 months with results approaching 9 months in some individuals with a side effect profile that’s almost identical to the other approved neuromodulators. No increase in brow ptosis, lip ptosis, in headache—everything’s about the same. The side effects don’t last longer, but the result lasts longer. It’s really a win for the physician and a huge win for the patients,” Dr. Dover says.

Based on his experience and surveys of patients and physicians, Dr. Dover says, on average, patients come in for neuromodulators 1.8 times per year for a treatment that has needed to be done three times per year to maintain results. Daxxify is “the first neuromodulator that will give patients lovely results when it’s done twice a year. We should be able to have a nice even result that is maintained and compelling day in day out, month in month out with injections twice a year.”

He is excited to offer Daxxify to patients in his practice, where several patients have been asking for longer lasting results.

“We’ll mention this to every single patient who we treat with neuromodulators and we’ll tell them, ‘We have a new neuromodulator as safe as what we’ve been using for years, but it lasts 6 months and up to 9 months instead of 3 to 4 months. Would you like to try it?’” He says some patients may have questions about its safety compared to other neuromodulators and based on his work in the clinical trials and the data on about 3000 patients, he can assure them that Daxxify is as safe as previously used neuromodulators.

“Daxi really addresses the greatest unmet need in neuromodulators—duration. For years, we’ve had 3 to 4 months of effect and suddenly we have longer duration with safety. It’s what patients want, it’s what doctors want,” Dr. Dover says.

Aesthetic specialists are also eyeing Galderma’s investigational RelabotulinumtoxinA, a ready-to-use liquid botulinum toxin A with a proprietary strain. Topline results from two Phase 3 clinical studies show it improves both glabellar and lateral canthal lines with a rapid onset of action and a long duration up to 6 months.