FDA Approves Daxxify: 8 Things to Know About the New Botox Alternative

The anti-wrinkle treatment may last twice as long as similar injectables. Here’s what dermatologists are saying about it.

The U.S. Food and Drug Administration (FDA) has approved Daxxify, a new injected medicine for smoothing facial wrinkles in adults, which dermatologists see as the first major competitor to Botox to emerge in decades.

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

What’s different about Daxxify is that it may keep wrinkles at bay for even longer. In clinical trials submitted to the FDA for approval, 80 percent of people using Daxxify had no or minimally visible facial wrinkles after four months, and roughly half of participants still had little evidence of wrinkles at six months.

“Daxxify will definitely change the neuromodulator market because of its increased longevity,” says Joshua Zeichner, MD, an associate professor and the director of cosmetic and clinical research in the department of dermatology at Mount Sinai Hospital in New York City.

The path to approval for Daxxify wasn’t completely wrinkle-free, however. An FDA inspection of the Daxxify manufacturing plant in June 2021 identified problems with quality control and what’s known as the working cell bank, or cells with the active ingredient in the drug. Revance, the company that makes Daxxify, stressed in a January 2022 statement that the FDA had concerns with the manufacturing facility but not with the safety or effectiveness of the new drug.

Here’s what else dermatologists want you to know about Daxxify.

1. Daxxify Works Similarly to Botox

Neuromodulators, a family of medicines that includes Daxxify and Botox, essentially freeze wrinkles by injecting a minute amount of botulinum toxin into underlying muscle, causing the tissue to relax and create a smoother appearance for overlying skin, according to the ASDS. The effect wears off over time, and many people get multiple injections each year in order to maintain the look of wrinkle-free skin.

2. But Daxxify Is Different From Botox in Other Ways

One thing that sets Daxxify apart from Botox and other neuromodulators is its duration of effectiveness, dermatologists say. “While most of the other products are reported to last somewhere in the range of three to five months, most patients only get about a three-month effect,” Dr. Zeichner says. “The results with Daxxify are reported to last around six months, which ultimately means fewer trips to the office and happier patients.”

In addition, Botox and other neuromodulators are made from what’s known as human serum albumin, says Nazanin Saedi, MD, a board-certified dermatologist at Dermatology Associates of Plymouth Meeting and a clinical associate professor at Thomas Jefferson University in Philadelphia. Daxxify doesn’t contain any human or animal products, and is instead made from peptides or amino acids.

Peptides may help make Daxxify last longer as a wrinkle-smoother than other neuromodulators, dermatologists say. And, unlike Botox and some other neuromodulators that require refrigeration, Daxxify can be stored at room temperature, Dr. Saedi says. (Xeomin also does not require refrigeration.)

3. In Studies, Daxxify Worked to Treat Wrinkles in Most People

The FDA approved Daxxify on the basis of clinical trial data collected on more than 2,700 patients, who received a total of 4,200 treatments. One month after injections, 98 percent of patients had little or no appearance of wrinkles. Half of patients were completely or nearly wrinkle-free at the injection area after six months, and some people still had results after nine months.

4. Side Effects for Daxxify Appeared Minimal, Too

In clinical trials, researchers didn’t observe any serious treatment-related side effects, according to Revance. The most common side effects seen in the clinical trials were headache, experienced by 6 percent of users, followed by drooping eyelids, experienced by 2 percent of users, and facial asymmetry, experienced by 1 percent of users.

5. Like Botox, Daxxify May Be Used for Reasons Other Than Wrinkles

Botox is FDA-approved for a wide variety of uses, including as a treatment for chronic migraines, overactive bladder, some types of urinary incontinence, neck muscle spasms, and severe underarm sweating. Daxxify is FDA-approved only to smooth frown lines, whereas Botox is also approved to treat other parts of the face, such as the crow’s-feet and forehead.

While companies aren’t allowed to promote drugs for unapproved uses, doctors are free to prescribe medicines for purposes that aren’t yet cleared by the FDA, a practice known as “off-label” utilization.

“Botox has so many indications besides aesthetic use, and I foresee that being the same for this new neuromodulator,” Saedi says.

6. Daxxify May Be More Appropriate for People Who’ve Tried Another Injectable First

That’s primarily because the results of Daxxify can last up to twice as long as other neuromodulators, such as Botox, Zeichner says. “Because the effect lasts much longer, you cannot undo an outcome that you are not happy with. Once you have an established relationship with a doctor and you are happy with your injection pattern, then it would be time to switch over to a longer-lasting product,” he explains.

Zeichner likened it to trying on a new permanent hair color with a new hairstylist. Maybe you’ll be satisfied with the results or maybe you won’t. “It’s much safer to start out with a temporary color to make sure you’re happy with the look first,” Zeichner notes.

7. It’s Unclear How Much Daxxify Will Cost

Although 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 people money, dermatologists say. That’s because the price per visit is likely to be higher for Daxxify than for Botox, Saedi says.

Revance hasn’t disclosed pricing information for Daxxify yet, and the drug isn’t yet on the market.

8. Daxxify Isn’t Yet Available — Look for It in 2023

Dermatologists expect this new neuromodulator to be widely available for U.S. patients starting sometime in 2023, Saedi says. If you’re interested in trying the injectable, ask your dermatologist.