As I write this, I’m on the flight back to Boston from the Daxxify PREVU weekend in Nashville at REVANCE corporate headquarters. “It’s about time” was the theme of the weekend and is a clever play on words.
Daxxify PREVU weekend in Nashville at REVANCE corporate headquarters
The History of Daxxify
Daxxify is not only the first long-acting neuromodulator on the market, but it is also the fruit of 20 years of research by a company founded in a Silicon Valley think tank in 2002. The founders of Daxxify wanted to explore the use of peptides connected to biologics such as insulin and botulinum toxin, with the initial idea to allow them to be delivered through the skin.
The founders moved their lab to a garage in Mountain View, California, in 2004. They renamed the company Revance in 2006 and, in 2007, started the clinical development of a topical botulinum toxin gel for use in the crow’s feet area. They started manufacturing in 2010 and began testing on people in 2012. They found that it worked even better as an injection and in 2014, started clinical development of what is now Daxxify.
In 2017, the founders published the landmark multi-year phase 3 Sakura study. There was a delay of initial approval by the FDA during COVID because of a quality control check with something called a cell bank used for the manufacture. This was corrected, and Revance finally received approval from the FDA earlier this year. Patients and doctors that were part of the initial studies in 2015 have been eagerly awaiting its release. So, “it’s about time” refers not only to the long development time but to the first and only long-duration neuromodulator on the market.
I am very excited to be able to be one of the first practices to be able to offer my patients treatment with Daxxify. Revance has selected 400 experienced injectors from around the US to get initial access to Daxxify and flew us to Nashville so that we could learn the nuances of its use directly from the scientists involved in its development and some of the doctors that were part of the initial study. Unlike many new products that start overseas or in Canada first, Daxxify is currently only available in the US.
An Insight Into the Daxxify PREVU
Everyone invited to be in the room has many years of experience using and getting good results with neurotoxins. When Daxxify was compared to Botox, it has a stronger effect, faster onset, and longer duration as well as higher satisfaction in experienced patients with a comparable amount of core neurotoxin.
The Sakura study is the largest and longest of its kind, treating patients up to 3 times and following out to 21 months. This study showed that DAXXIFY (using the same amount of core neurotoxin as Botox) has a median duration of 6 months, meaning that 1/2 of the patients had none or mild frown activity at 6 months. In some patients, the result lasted 9 months. By comparison, Botox has an average duration of 3-4 months with an occasional patient lasting 6 months.
The graphs showed that Daxxify reliably lasted at least 2 months longer. What that means is that if you are the average patient who gets Botox injections every 3-4 months in the glabellar area frown lines ( the “11’s”), you can expect at least 6 months from Daxxify. Likewise, if you are that patient where it is wearing off at 3 months, you should get 5 months from Daxxify.
Jonathan Hall, MD, FACS at DAXXIFY PREVU Weekend
Faster Onset with Stronger Results
The doctors who were part of the original study confirmed this and also said it seemed to work more quickly, usually in 1-2 days. They also said that many of the experienced patients who had previously had Botox said it “felt lighter” and they noticed that the effect was stronger, ie, the wrinkles were smoother. The study regarded success as going from severe to none or mild but the investigators said that more of the patients went to “none” with Daxxify, even men who typically have stronger muscles.
In the prelude study that followed, Sakura tested its off-label use in other areas typically treated with Botox. In 74% of patients who had previously had neurotoxin treatment and 26% of patients who had never had a neurotoxin, 98% of all patients were satisfied with the results with Daxxify. 93% of patients who have previously had Botox preferred the Daxxify results at two weeks. They liked the “complete effect” of getting some brow elevation and felt it was more effective.
The prelude study also suggests that the median duration in other areas such as the forehead and lateral Canthus ( “crow’s feet”) is 20 weeks. That’s great news because. at least in the lateral canthus. we are typically only seeing 12-week duration with Botox and other neurotoxins.
Botox vs. Daxxify
The units of Botox are not directly equivalent to the units of Daxxify. Although the glabellar study compare 40 units Of Botox to 20 units of Botox the core amount of neurotoxin in each treatment was the same and there are nuances in the effect. So although someone who normally receives 50 units of Botox may receive 100 units of Daxxify, the injection pattern used and the effect is a little different. In general, a lighter comparable dose is used in the forehead.
Is it Safe?
The safety profile in the Sakura study is the same as with Botox. There were no serious adverse reactions in the study. The most common adverse reactions (more than 1%) were headache (6%), eyelid ptosis or drooping of the eyelid (2%), and facial paralysis (1%). This last category is a general catch-all for things like the drooping of an eyebrow or a “Spock” brow. These are the same possible effects as could happen with Botox, although in the few patients who developed ptosis after Daxxify, the effect did last longer. It was around 1 week longer ie, 5 weeks with Daxxify vs 4 weeks with Botox.
The active ingredient at the core of Daxxify is botulinum toxin A ( BoNT A), the same as Botox. Unlike Botox, Daxxify doesn’t use human serum albumin or the use of animal products in the manufacture. One of the investigators joked that it’s the first neurotoxin that is “vegan.” One doctor said after describing Daxxify to his patient as having the same core toxin she said “ Daxxify is like the newest sister! Modified and made better!”
Does it Cost More?
Daxxify costs more but it also lasts an average of 6 months and up to 9 months in some patients. It is the first innovative formulation in more than 20 years and provides the benefit of a more consistent look.
It requires only 2 treatments per year and early studies have shown that it is preferred by 93% of experienced patients at two weeks. The majority of my patients have expressed a desire for longer-lasting treatment and are thrilled by only needing to come in every 6 months.
For the patients that currently get their Botox every 6 months, they can continue that interval but will have more consistent results with Daxxify without the peaks and valleys. We will still offer Botox in the office for those patients who prefer a short-acting wrinkle treatment.
We are pleased to be one of the first practices to be able to offer this first-of-its-kind, long-lasting neuromodulator to our patients who want a longer-lasting neurotoxin.