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


Dermatologists consider Daxxify, which is a new injectable drug for erasing facial wrinkles mostly in adults, Botox's first serious competition in decades. The FDA just authorized Daxxify.

Daxxify is part of the neuromodulator class of medications, which also includes Botox, Dysport, Jeuveau, and Xeomin. The benefits of these well-known neuromodulators endure for an average of three months (ASDS).

Daxxify's unique selling point is that it may be able to delay the onset of wrinkles for even longer than other anti-aging products. Clinical studies submitted to the FDA for clearance found that after four months of taking Daxxify, 80% of individuals had no or slightly apparent facial wrinkles, and 50% of total participants still showed no evidence of visible wrinkles after 24 to 30 weeks.

Daxxify's road to market clearance wasn't without its share of bumps. In June 2021, the FDA inspected the Daxxify factory and found issues with quality control and the operational cell bank, which contains the drug's active component in living cells. The makers of Daxxify, Revance, released a statement in January 2022 emphasizing the FDA's concerns with the production facility rather than the new drug's safety or efficacy.

Here's some more information dermatologists think you should know about Daxxify −

Why Daxxify Is Effective

Neuromodulators such as Botox and Daxxify "freeze" wrinkles with the help of injecting a small amount consisting of botulinum toxin into the muscle that lies under the skin. This causes the tissue to relax, which gives the appearance of fewer wrinkles on the skin. However, the impact does diminish with time; hence, many people choose to have further injections on a yearly basis in order to preserve the youthful appearance of their wrinkle-free skin.ss

To be sure, Daxxify is Distinct from Botox in a few key Respects, but There are Others.

Dermatologists have noticed that Daxxify lasts far longer than Botox and other neuromodulators. Dr. Zeichner notes that although "most of the other products are stated to last somewhere in the region of three to five months," in practice, the majority of patients get results for just around three months. Patients should expect to see continued improvement with Daxxify for up to six months between office visits.

Human serum albumin is used to create Botox and other neuromodulators. Daxxify is not derived from any animal or human sources; rather, it is constructed entirely of peptides.

Dermatologists have speculated that the peptide content of Daxxify contributes to its extended duration as a wrinkle-smoothing neuromodulator. In addition, Dr. Saedi states that Daxxify doesn't need to be kept cold as Botox and other neuromodulators do; it may be kept at room temperature. (Neither does Xeomin need to be stored in the fridge.)

Researchers Found that Daxxify successfully Reduced Wrinkles in most Participants.

The data obtained from clinical studies of Daxxify, in which a total of 4,200 doses were administered to over 2,700 participants, were utilized to get clearance from the FDA. Ninety-eight percent of patients reported a greatly reduced appearance of wrinkles one month after having injections. Half of the patients who received therapy said that there were no visible wrinkles at the injection site six months after treatment, and some individuals continued to notice improvement nine months after treatment.

Daxxify Seems to have few Negative side Effects.

According to Revance, the medicine was unrelated to any serious side effects throughout the clinical investigations. Six percent of those who participated in the clinical studies reported having some kind of headache, followed by two percent who said they had droopy eyelids and one percent who said they had facial asymmetry.

Daxxify, like Botox, may be used for Purposes Outside of Wrinkle Treatment.

Overactive bladder, various forms of urine incontinence, muscular neck spasms, and excessive underarm perspiration are just some of the conditions that Botox has been licensed to treat by the Food and Drug Administration. Daxxify has only been licensed by the FDA to treat frown lines, whereas Botox has also been approved to treat crow's feet and the forehead.

While pharmaceutical firms are prohibited from promoting their products for applications not recognised by the FDA, physicians are permitted to utilise medications for "off-label" reasons.

Saedi predicts the new neuromodulator will follow in the footsteps of Botox, which has numerous applications beyond cosmetic ones.

Daxxify may be best for Those who have Already Tried Another Injectable Treatment.

This is because, according to Zeichner, Daxxify's effects might continue for up to twice as long as those of other neuromodulators like Botox. You can't reverse a bad result if you don't like it, and the effect lasts for a long time. He notes that after a patient has developed a comfortable routine with their doctor's injections, it is appropriate to transition to a longer-acting medicine.

Zeichner compared the experience to going to a new hair salon to experiment with a permanent hair colour. The outcomes may or may not meet your expectations. Whether you want to try out a new hair colour but aren't sure if you like it, Zeichner recommends starting with a temporary shade.

The Price of Daxxify has not been Determined

Dermatologists have expressed doubt that patients would really save money by switching to Daxxify from Botox or another neuromodulator due to the reduced frequency with which patients would need to visit the clinic for Daxxify injections. Because, as Saedi points out, Daxxify will most certainly have a greater cost per visit than Botox.

Daxxify is not yet on the market, and Revance has not yet released price information.

You'll Have to Wait Until 2023 to Use Daxxify

Dermatologists predict that by the year 2023, the new neuromodulator will be available to many patients in the United States.

Updated on: 23-Feb-2023

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