New anti-wrinkle treatment that lasts twice as long approved by FDA

The quest for the fountain of youth has individuals seeking various treatments to preserve their fresh-faced glow. 

Since its first use in the 1980s, Botox has been a popular choice for many [1]. Have you heard about Daxxify, the new kid on the block?

What exactly does Botox do?

Botulinum toxin, also known as Botox for short, is mainly used for aesthetic purposes (previously for treating crossed eyes and eye twitching, among others). Botox injections restrict specific nerve chemical signals, primarily ones that make muscles contract. The most conventional use of these injections is to temporarily relax facial muscles that cause wrinkles around the eyes and forehead.

For many years, one of the most customary cosmetic procedures has involved injecting small volumes of the botulinum toxin into parts of the face. The toxin is a neuromuscular blocking agent, paralysing certain facial muscles, leading to a smoothing of the skin and a reduction in wrinkles [2].

Botulinum toxin, also known as Botox for short, is mainly used for aesthetic purposes (previously for treating crossed eyes and eye twitching, among others).

The most common brand of treatment is the familiar Botox. However, several other companies have developed their competing botulinum formulations over the years. Despite these competitions, Botox has conquered the anti-wrinkle market for decades, with no substantial innovation in the biotech world of anti-wrinkle treatment.

For individuals looking for an alternative, the FDA (US Food and Drug Administration) has recently approved a new anti-wrinkle treatment called Daxxify. Like Botox, Daxxify freezes wrinkles by paralysing muscles but lasts at least twice as long as existing treatments, with single injections working for six and nine months.

More information on Daxxify

Daxxify is in a family of medications known as neuromodulators, which includes Botox, Dysport, Jeuveau and Xeomin. The effects of these neuromodulators generally last about three months, according to the ASDS (American Society for Dermatologic Surgery) [3].

The path to approval for Daxxify wasn’t as easy, nevertheless. In June 2021, an FDA inspection of the Daxxify manufacturing plant found quality control issues in cells with the drug’s active ingredient or what’s known as the working cell bank [4]. 

According to Revance in a January 2022 statement, the company that produces Daxxify highlighted that the FDA had manufacturing facility concerns, but not with the safety or effectiveness of the new drug [5]. 

The evolution of Daxxify took years and was originally focused on creating a Botox-like anti-wrinkle treatment without having to be injectable. As the research team at Revance Therapeutics researched other ways to stabilise the toxin molecules, they designed a novel peptide technology that unexpectedly improved the duration of the treatment.

A Phase 3 human trial involving nearly 3,000 participants discovered that Daxxify effectively reduced wrinkles but endured much more prolonged than current treatments. The outcomes of Botox injections commonly begin to wear off after around three months, but the clinical trial found Daxxify lasted at least six months, and in some patients, up to nine months.

Daxxify was initially ready for FDA approval in 2020. Still, a combination of pandemic delays and quality control matters at the company’s production factory led to a long pause on its final authorisation.

What else do you need to know about Daxxify?

Here are some more details you need to know about this new Botox alternative:

Like Botox, Daxxify can address other issues aside from wrinkles: Botox is FDA-approved for a wide variety of uses, as well as a treatment for neck muscle spasms, chronic migraines, overactive bladder, some types of urinary incontinence and severe underarm sweating [6]. On the other hand, Daxxify is FDA-approved only to smooth frown lines, whereas Botox is also approved to treat different parts of the face, like the forehead and crow’s-feet. 

While companies aren’t allowed to advertise drugs for unapproved uses, physicians are unrestricted to prescribe medicines for purposes that the FDA doesn’t clear yet – a practice known as “off-label” utilisation. 

Daxxify worked for wrinkles in most studies: the FDA authorised Daxxify based on clinical trial data collected on over 2,700 individuals who received 4,200 treatments. A month after injections, 98 per cent of patients had little or no appearance of wrinkles. Half of the patients were totally or nearly wrinkle-free at the injection area after six months, and some still had results after nine months. 

Side effects appeared minimal: researchers didn’t observe any severe treatment-related side effects in clinical trials, according to Revance [7]. The most common side effects were headache, experienced by six per cent of users, drooping eyelids, shared by two per cent and facial asymmetry, experienced by one per cent of users. 

Daxxify is unlike Botox in other ways: dermatologists say one factor that differentiates Daxxify apart from Botox, as well as from other neuromodulators is its duration of effectiveness. Reported outcomes with Daxxify are said to last around six months, which eventually translates into lesser trips to get treatment.

In addition, Daxxify doesn’t contain any human or animal products and is instead made from peptides or amino acids. Botox and other neuromodulators are made from what’s known as human serum albumin. Also, unlike Botox and other neuromodulators requiring refrigeration, Daxxify can be stored at room temperature.

It’s still unknown how much Daxxify will cost: though some people may not need to see the dermatologist as often for Daxxify injections as they do for Botox or other neuromodulators, this may not translate into saving money. This is because the price per visit is likely higher for Daxxify than for Botox. Revance hasn’t disclosed pricing details for Daxxify yet.

Daxxify isn’t available yet: dermatologists anticipate this new neuromodulator to be widely available for US patients sometime in 2023. If you’re interested in trying the injectable, ask your dermatologist.

The information included in this article is for informational purposes only. The purpose of this webpage is to promote broad consumer understanding and knowledge of various health topics. It is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.

[1] https://www.macleans.ca/society/health/meet-the-vancouver-couple-who-pioneered-botox/
[2] https://newatlas.com/health-wellbeing/daxxify-botox-rival-approved-fda-long-lasting/
[3] https://www.asds.net/skin-experts/skin-treatments/neuromodulators
[4] https://www.fda.gov/media/153014/download
[5] https://bwnews.pr/3eNnDfq
[6] https://www.everydayhealth.com/urinary-incontinence/guide/
[7] https://investors.revance.com/news-releases/news-release-details/revance-announces-fda-approval-daxxifytm-daxibotulinumtoxina

The information included in this article is for informational purposes only. The purpose of this webpage is to promote broad consumer understanding and knowledge of various health topics. It is not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health care provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it because of something you have read on this website.