Daxxify – will it compete with the market leader Botox?

Introduction

Daxxify™ long-acting anti-wrinkle treatment on the street, making other botulinum toxin manufacturers extremely nervous.

For one main reason. It lasts longer, so it only needs to be injected once to twice a year.

In fact, in a landmark trial, 80% of patients had no or faint facial wrinkles after four months. And around half had little evidence of wrinkles at six months.

But do other brands using botulinum toxin need to be worried? Many injectors already have reservations.

More prolonged action means that aesthetically displeasing side effects such as brow or eyelid droop may last the same time.

Read more to discover why I won’t be rushing to use this as the new Botox alternative soon. However, I may change my mind.

daxxify bottle on a ceramic surface

What is Daxxify long-acting anti-wrinkle treatment?

Daxxify™ is the new Botulinum Toxin Type A (BoTNA) used to smooth lines and wrinkles.

Daxxify™ is part of a family of medicines known as neuromodulators or neurotoxins, which includes brands such as Botox, Dysport, Bocouture, and Jeuveau.

How does botulinum toxin work?

Botulinum toxin works by temporarily blocking the release of chemical signals from nerves that contract the muscles of the face. By relaxing these muscles, the toxin smoothes any overlying lines and wrinkles.

As the toxin’s effect lasts only three months, many people need multiple injections each year. The results with Daxxify are reported to last around six months. That equates to needing only two injections per year—or just one.

What is Botulinum Toxin used for?

Botulinum toxin is used to reduce the appearance of wrinkles and fine lines which appear on the face during expression.

Botulinum toxin is administered through injections, typically in the forehead, between the eyebrows, and around the eyes.

Although the neurotoxin is most commonly used for cosmetic purposes, botulinum toxin is also used to treat various medical conditions, including muscle spasms (such as cervical dystonia or spasmodic torticollis), excessive sweating (called hyperhidrosis), and migraine.

Is Botulinum toxin safe?

Botulinum toxin is extremely safe, manufactured, and injected in low doses.

The effects of botulinum toxin and any unwanted side effects, such as eyelid or brow droop, are temporary. When these occur, they tend to wear off in one to two weeks.

But is this about to change with Daxxify long-acting anti-wrinkle treatment, and will the side effects last much longer?

This means choosing your injector will be even more critical. 

Especially if they are brandishing an ultra-long-acting muscle-relaxing drug that could cause an area of your face to drop for months rather than a few weeks.

Who makes Daxxify?

Daxxify™ is made by a company in America called Revance Therapeutics

Daxxify long-acting anti-wrinkle treatment is also known as DaxibotulinumtoxinA or DAXI.

daxxify logo in black lettering on white backgrund

Is Daxxify safe?

Daxxify™ recently received FDA approval, which immediately increased its share price by over 18%. This means that the market feels that Daxxify™ is a serious competitor to AbbVie, the new owner of the best-known brand Botox.

FDA-approved means:

  1. Daxxify™ has undergone extensive human and animal trials to ensure it is safe and works.
  2. The benefits of Daxxify’s intended use outweigh its known risks.
  3. Daxxify™ is manufactured and labelled correctly.

However, the path to approval for Daxxify wasn’t straightforward. An FDA inspection of the Daxxify manufacturing facility in June 2021 identified problems with quality control and record keeping. These were quickly rectified, to be fair.

How did the FDA approve Daxxify?

The FDA approved Daxxify using trial data collected on more than 2,700 patients who received around 4,200 treatments.

In this trial:

Ninety-eight per cent had little or no appearance of wrinkles one month after being injected with Daxxify. 

Fifty per cent (half of the patients) were still completely or nearly wrinkle-free after six months.

Some still had results after nine months.

What is Daxxify licensed for?

Unlike the other brands, licensed to treat all three areas of the upper face, Daxxify is only licensed to treat the frown lines, which are the area between the eyebrows.

A licence for the other upper face areas, namely the forehead and crow’s feet, will soon follow, as they are already at the phase 2 trial stage.

Once they are at stage 3, the drug is ready to compete and rival the shorter-acting formulations.

Does Daxxify work?

To prepare for the introduction of Daxxify™, Revance has recently announced two publications detailing how the frown lines should be assessed before injection with botulinum toxin.

It is an area previously and erroneously thought of as straightforward, with few risks, by both novice and experienced injectors alike.

Is this a coincidence? Or are they worried that using Daxxify™ without such a thorough assessment will result in a surge of unsatisfied customers?

This bad press could then have negative publicity on such a game-changing product. Especially when getting a new product on the market costs over one billion pounds.

Publications coinciding with the announcement of Daxxify

Impact of Glabellar Injection Technique with DaxibotulinumtoxinA for Injection on Brow Position 

Integrative Assessment for Optimizing Aesthetic Outcomes When Treating Glabellar Lines with Botulinum Toxin Type A: An Appreciation of the Role Of The Frontalis 

What makes Daxxify different from other neuromodulators?

The real advantage of Daxxify™ is that it lasts up to 6 months, which is twice as long as the other toxins on the market. 

Unlike other brands, Daxxify also acts within one to two days and does not need to be kept in a refrigerator.

How else is Daxxify different?

Daxxify™ is unique because it is the first botulinum toxin not made with albumin but a peptide (or protein called RTP004) instead, which may be why it lasts longer.

This has been labelled as peptide exchange technology.

See the complete Prescribing Information for Daxxify, including the Medication Guide.

What are the side effects of Daxxify?

The preliminary trial using Daxxify™ showed it has few serious side effects. This is reassuring.

The most common side effects were headache (6%), drooping eyelids (2%), and facial asymmetry (1%).

The safety profile of Daxxify™ was the same as other available neuromodulators.

This makes Daxxify, the new antiwrinkle treatment on paper, safe and more convenient, as you only need to be injected once or twice a year.

See their Press Release page, which is also showcased on Businesswire.com.

Conclusion

Daxxify is a serious contender to the shorter-acting brands of cosmetic botulinum toxin. The attraction of longer-lasting effects is obvious, meaning fewer injections each year to keep patients wrinkle-free.

Injections, however, need to be even more carefully performed. Whether Daxxify will take over the market based on its long-lasting effect will depend on consumer demand and the confidence of injectors. As with many new products, only time will tell.

References 

Solish, N., Carruthers, J., Kaufman, J. et al. Overview of DaxibotulinumtoxinA for Injection: A Novel Formulation of Botulinum Toxin Type A. Drugs 81, 2091–2101 (2021). https://doi.org/10.1007/s40265-021-01631-w

Nowell Solish, MD, Michael A C Kane, MD, Brian S Biesman, MD, Jessica Brown, PharmD, Conor J Gallagher, PhD. Impact of DaxibotulinumtoxinA for Injection on Brow Position and Frontalis Muscle Activity Following Treatment of Glabellar Lines, Aesthetic Surgery Journal, 2022; sjab362, https://doi.org/10.1093/asj/sjab362

Vince Bertucci, MD, Jean D Carruthers, MD, Deborah D Sherman, MD, Conor J Gallagher, PhD, Jessica Brown, PharmD, Integrative Assessment for Optimizing Aesthetic Outcomes When Treating Glabellar Lines With Botulinum Toxin Type A: An Appreciation of the Role of the Frontalis, Aesthetic Surgery Journal, 2022;, sjac267, https://doi.org/10.1093/asj/sjac267

Fabi, Sabrina G. MD*; Cohen, Joel L. MD†; Green, Lawrence J. MD‡; Dhawan, Sunil MD§; Kontis, Theda C. MD; Baumann, Leslie MD¶; Gross, Todd M. PHD**; Gallagher, Conor J. PHD**; Brown, Jessica PharmD**; Rubio, Roman G. MD**. DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study. Dermatologic Surgery 47(1):p 48-54, January 2021. | DOI: 10.1097/DSS.0000000000002531

Andy Taylor

I am a Consultant working in the NHS specialising in non-surgical aesthetic treatments.