01 - daxi new botox

Is Daxi the new Botox?

Many people are wondering if DAXI is the new Botox because a new injectable procedure to remove facial wrinkles and fine lines has hit the market. The business Revance Therapeutics, Inc. developed the neuromodulator daxibotulinumtoxinA, also referred to as DAXI. DAXI is an injectable treatment intended to reduce the appearance of fine lines and wrinkles, much like other neuromodulators in the botulinum toxin type A family, such as Botox, Xeomin, and Dysport. In particular, the FDA is expected to approve DAXI for treating glabellar lines, sometimes referred to as forehead lines or “11s.” In addition to treating glabellar lines, DAXI is currently being tested for treating crow’s feet, glabellar lines throughout the upper face, and medical issues such as adult upper limb spasticity and cervical dystonia.

In contrast to other neuromodulators on the market, this new medicine stands out since it includes a novel peptide that adds to DAXI’s durability. While the majority of conventional botulinum toxin type A treatments provide benefits that last 3–4 months on average, DAXI outcomes have a median duration of 6 months, with patients experiencing a return to their pre-treatment wrinkle levels after about 28 weeks. As a result, compared to other injectable treatments now on the market, the synthesis of DAXI with the proprietary stabilizing protein has the potential to more than double the amount of time the effects of the treatment are noticeable. Providers are keen to add DAXI to the list of available injectable neuromodulators due to its capacity to remove severe glabellar lines and durable results.

Dr. Galope, a skilled and board-certified cosmetic dermatologist, stays up to date on the latest anti-aging, injectable, and skin care techniques. In her private, Upper East Side dermatology office, Dr. Galope was one of the first doctors in NJ to utilize Botox. Dr. Galope has received numerous accolades for more than 25 years as one of the top dermatologists in New Jersey. He is a platinum Allergan provider of dermal fillers like Juvederm, Restylane, and others. Her “less is more” concept, which she pioneered in non-invasive cosmetic operations, will produce gorgeous, naturally-looking aesthetic results.

Daxi vs. Botox shots

The most common kind of botulinum toxin at the moment Botox is a readily available injectable therapy. FDA approval for the use of Allergan’s Botox, which is used to treat medical ailments such persistent migraines, blepharospasm, cervical dystonia, upper lip spasticity, and hyperhidrosis, as well as aesthetic issues like forehead wrinkles, frown lines, and crow’s feet. When botulinum toxin is injected into the treatment area, it acts by “freezing” the muscle, causing it to relax. This is how the two neuromodulators work similarly. This freezing of the muscle aids in removing the evidence of dynamic wrinkles, which are brought on by muscular movements, while treating aesthetic difficulties.

But there are some significant differences between Botox and DAXI. Both medications have a type of botulinum toxin as their main component, but only DAXI has a patented peptide excipient, which alters how the product works and may be stored. Most importantly, DAXI’s results last twice as long as Botox’s results do, lasting up to six months as opposed to Botox’s benefits, which persist for three to four months. This is crucial because, unlike Botox, which may need three to four treatments a year to retain a young appearance, DAXI patients only need two treatments each year to keep a smooth, wrinkle-free face. Additionally, clinical trials indicate that up to 97.5% of patients reacted to the DAXI treatment, demonstrating the very high response rate of DAXI. This surpasses the prices of all of DAXI’s rivals, including Botox.

Therapeutics Relevance

The Silicon Valley-based newcomer Revance Therapeutics, Inc. is a leader in the development of neuromodulators for the aesthetic industry.  DaxibotulinumtoxinA (DAXI), a cutting-edge neuromodulator medication developed by Revance, offers both cosmetic and therapeutic uses. They have created a brand-new neurotoxic with a longer half-life that will pose a serious threat to Botox. Clinical investigations have demonstrated that DAXI has a substantially longer half-life than Botox, lasting for almost six months.  On February 6, 2020, DAXI gained permission for its biological license application to treat glabella (frown) lines, and since then, Revance has been coordinating with the FDA to request full approval of the procedure. With 2.6 million total facial injectable procedures performed in 2018 alone, neuromodulators are the most popular noninvasive cosmetic surgery performed in the United States. This two-billion-dollar business is extremely competitive.

How does DAXI compare to neurotoxins like Botox and others?

Other neurotoxic injectable treatments are currently available on the market, such as Botox, Dysport, Xeomin, and Jeuveau. With about 7.5 million botulinum toxin type A treatments carried out in the United States alone in 2018, these procedures are the most widely used minimally invasive ones. Even while each product performs a similar job, they all have distinctive qualities that are significant to consider when weighing your selections.

The main benefit of DAXI over Botox, which is produced by Allergan, is its capacity as a long-lasting neuromodulator. OnabotulinumtoxinA (Botox) was FDA-approved for the glabella region about thirty years ago. In the United States, Botox is currently the most widely used injectable due to its enormous popularity. However, one of the biggest issues with Botox is that its therapeutic impact wears off quickly. Botox normally has a cosmetic effect for 3 to 4 months before it wears off. A novel neuromodulator whose effects would continue for a longer time is very appealing to patients. Patients would only need to visit us twice a year for wrinkle injections thanks to DAXI’s twice as long, up to six-month, duration.

AbobotulinumtoxinA, also known as Dysport, is made by the business Galderma and has been FDA-approved in the US since 2009. Due to the product’s dispersion after injection, the procedure is most effective for individuals who have moderate to severe wrinkle severity around the forehead and eyes. Dysport is a deeper injection that covers a larger region when compared to Botox. Although Dysport likewise produces benefits more quickly than Botox (three to five days as opposed to seven to fourteen for Botox), the procedure only lasts for three to four months. As a result, DAXI will produce superior outcomes for the forehead area’s long-term treatment.

Since 2009, the FDA has approved the neuromodulator Xeomin, also known as incobotulinumtoxinA, to treat frown lines, cervical dystonia, persistent drooling, and upper lip spasticity. It is produced by the business Metz Aesthetics. It is comparable to DAXI in that the injectable solution does not contain a preservative, making the toxin more pure. This implies that results will manifest more quickly and the product can be kept at room temperature. Similar to Xeomin, DAXI therapy outcomes normally take three days to manifest, while the entire impact of the process takes seven to fourteen days. Xeomin is a very successful alternative for individuals who no longer respond to Botox treatment since it does not contain the preservative protein and patients are less likely to develop antibodies against the injection.

Before DAXI entered the market, prabotulinumtoxinA-xvfs, also referred to as Jeuveau was the newest Botox substitute. Jeuveau, developed by the business Evolus, stands out from the other neuromodulators available thanks to the usage of a patented technique known as “Hi-Pure.” This procedure is used to purify the protein during production, which should make injections safer. Jeuveau’s effects are noticeable for 3–4 months following treatment, just like with Botox, Dysport, and Xeomin. As a result, DAXI lasts longer than Jeuveau.

Which facial regions are suitable for Daxi injections?

The FDA is expected to approve DAXI for the treatment of glabellar lines, which develop on the forehead region of the face. The muscle between the brows tightens to generate vertical lines when you frown or are focused on something. Additionally, Revance is attempting to get FDA approval for treatments for crow’s feet and horizontal forehead lines on the upper face. The solution can also be used effectively “off-label” to treat neck creases for a non-surgical “neck lift.”

Has the FDA approved Daxi?

A relatively recent procedure to reduce fine lines and wrinkles on the top face is the injection of daxibotulinumtoxinA. Revance submitted DAXI to the FDA for clearance to treat glabellar lines following various phases of clinical trials to evaluate the efficacy of the procedure. Revance’s Biological License Application (BLA) was first granted by the FDA in February 2020, with the promise that they would study the application and make a decision on approval before the end of the year. Regrettably, the Covid-19 outbreak prevented the FDA from doing a thorough evaluation of the new medicine and forced them to postpone their decision. The FDA further postponed the approval in October 2021, citing a problem at Revance’s California production facility. In response, Revance requested a Type A meeting with the FDA to address the problem. As a result, Revance now anticipates complete FDA clearance of DAXI to treat glabellar lines by the end of 2022 (Sept 2022 update: This has since been approved as “Daxxify”; you can read more about it here).

Although the FDA has not yet given DAXI full approval, clinical trials have proven that it works as intended and that it is at least as safe as other neuromodulator injections now available. As a result, DAXI is currently a therapy option.

Daxi Is It Safe?

Yes! According to clinical research, DAXI is just as safe as other neuromodulators, if not safer. Of the 2,691 people who underwent the operation just once in the DAXI Phase 3 clinical trials, 882 underwent a second treatment and 568 underwent a third. Only 17.8% of participants taking part in this open-label study had adverse events that were directly attributable to the medication, and the majority of these were mild side effects. As with other neuromodulators, bruising at or near the injection site, swelling, and redness are typical, moderate adverse effects of DAXI. No significant side effects of the therapy were observed in Phase 3 clinical trials.

What time will Daxi debut?

FDA approval is currently being sought by Relevance for their product. Although the FDA granted their biological license application in February 2020, there have been significant delays, primarily because of the Covid-19 epidemic. According to Revance, DAXI will receive official FDA approval to treat glabellar wrinkles on the face by the end of 2022. Update: This has been given the name “Daxxify” by the FDA and was authorized in September 2022.

What other clinical uses will DAXI have?

For the treatment of forehead lines, crow’s feet, full upper cervical lines, cervical dystonia, plantar fasciitis, and upper limb spasticity, Revance currently has 12 active clinical trials employing DAXI. According to published studies, 73% of patients had a substantial improvement in their forehead lines after 4 weeks, 97.5% of patients responded to the therapy, and 96% of patients said they were happy with the outcomes. More than any other neuromodulator now on the market, research has shown that the treatment’s effects last on average for 6 months, with the median onset time being 3 days following the surgery. Less than 1% of patients experience any major adverse effects, according to studies, demonstrating the treatment’s safety and efficacy.

How long will the DAXI of Revance last?

According to research, DAXI is the longest-lasting neuromodulator currently available. According to recent DAXI studies, the glabella area takes 24 weeks to heal, which is 8 weeks longer than the leading competitors. The severity of wrinkles does not revert to pre-injection levels for 28 weeks after therapy. Other parts of the face can soon be anticipated to have results and longevity compared to those. According to these findings, patients won’t require as many DAXI injections as they would with rival neuromodulators, which would require more frequent administration.

How do I begin using Daxi right away?

DaxibotulinumtoxinA injections are soon to become a significant rival for Botox, Dysport, Xeomin, and Jeuveau thanks to this innovative, intriguing medication. Daxxify / Daxi, a brand-new treatment, will be made formally available at Dr. Galope’s NJ dermatological practice. Dr. Galope is a dermatologist who specializes in cosmetic dermatology and has a practice in New Jersey’s Upper East Side. To find out if Daxxify/Daxi is the correct choice for you, call Dr. Galope at (201) 228-3200 or contact us online for a consultation. Dr. Galope is an expert in minimally invasive cosmetic injections and lasers.


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