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Daxxify is the newly FDA-approved long-acting Botox alternative. Daxxify is similat to Botox but it is a different brand, and it can be called the long-acting Botox alternative in West Palm Beach Gardens, Florida, for simplification. In reality, it is a long-acting Botulinum toxin.
Daxxify is the first and only peptide-powered, FDA-approved frown line treatment. Some patients have a median duration of 6 months and up to 9 months.
I have been waiting for this message for some time. The new neurotoxin DAXXIFY (DAXI) has been waiting for F.D.A. approval for some time. Due to timing delays related to COVID, it took some time for the longer-lasting injectable to go through the process. However, the day has finally come, and Revance’s DAXXIFY anti-wrinkle injection has finally been approved for severe glabella wrinkles. Daxxify can, of course, be used off-label to treat other areas as well. It will be a great alternative to treat the 11 lines, forehead wrinkles, and crow’s feet.
“We are very pleased that DAXXIFY’s labeling includes data demonstrating achievement of no or moderate wrinkle severity based on investigator and subject assessments, as this provides the basis for our marketing claims of the duration of effect,” said Revance C.E.O. Mark J. Foley. “We look forward to continuing to set new standards in aesthetics and to creating a new category of long-lasting peptide-enhanced neuromodulators.”
That was a significant announcement from the C.E.O. of Revance.
What sets Daxxify, the long-acting Botox alternative in West Palm Beach Gardens Fl aside?
The most significant difference between DAXXIFY and other neurotoxins on the market – Botox Cosmetic, Xeomin, Dysport, and Jeuveau – is the time the product lasts to freeze muscle movement and smooth lines and wrinkles. In clinical trials, DAXXIFY has been shown to last six months or longer, sometimes as long as nine months in some patients, making it the first FDA-approved neurotoxin to last longer than the standard three to five months.
Daxxify has the potential to be a significant game-changer.
DAXXIFY contains a stabilizing “peptide exchange technology” associated with increased longevity. In phase 3 clinical trials, most patients experienced a median duration of six months. Suffice it to say, we’re more than excited at the prospect of fewer visits to skilled injectors (think twice a year) to keep lines and wrinkles at bay.
What does this mean for patients?
“Over the years and after performing thousands of neurotoxin treatments for cosmetic facial enhancement, a common comment from patients who are generally satisfied with the results is that they ‘wish the effects would last longer,’” Dr. Dahabra says. “The approval of DAXXIFY is an important step towards meeting the wishes and expectations of patients.”
“Although it is now only approved for frown lines, it is likely to be used in other parts of the face such as the jawline, chin, crow’s feet, and forehead.” It is essential to mention that other neurotoxins are also used in this off-label manner.
When the work works longer, the patients have less time in the untreated phase. This will result in better long-term outcomes and gives patients more options to choose from.
How soon can you try it?
We can expect the injections to be available to everyone in early 2023.” Revance will start with an early education and training program called PrevU in late 2022, followed by a more comprehensive commercial launch next year,” he explains.
The approved label includes complete 36-week efficacy data from the Phase 3 SAKURA clinical program, making DAXXIFY™ the first and only long-acting neuromodulator to demonstrate a median duration of action of 6 months and up to 9 months in some patients.
Based on data from SAKURA, DAXXIFY™ can provide year-round results with just two treatments per year and is effective, generally safe, and well tolerated.
Powered by Peptide Exchange Technology™, DAXXIFY™ is the first true innovation in neuromodulator product formulation in over 30 years.
Revance Therapeutics, Inc., a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced that the United States (U.S.) Food and Drug Administration (F.D.A.) has approved DAXXIFY™ (daxibotulinumtoxinA-land) for injection for the temporary improvement of moderate to severe wrinkles (glabellar wrinkles) in adults.
DAXXIFY™ is the first and only neuromodulator stabilized by Peptide Exchange Technology™ (P.X.T.) and contains no human serum albumin or animal components. Most importantly, DAXXIFY™ can address the duration of therapeutic effect, which we believe is the most significant unmet need in existing neuromodulators for both consumer and injectable applications.
The F.D.A. approval, Revance’s first, expands the company’s portfolio of innovative aesthetics and expands the company’s access to the growing U.S. injectable market of facial products, further establishing Revance as an innovation leader in the industry.
“The F.D.A. approval of DAXXIFY™ is a milestone achievement for the company as it represents the culmination of years of pioneering research and development, made possible by the outstanding performance of Ravence’s talented team, along with the strong support of the medical community. It has been an incredible and rewarding journey to realize our vision and bring this disruptive innovation to an industry that has seen little change in over 30 years,” said Mark J. Foley, C.E.O. “Importantly, we are very pleased that the DAXXIFY™ label includes data demonstrating achievement of no or moderate wrinkle severity based on investigator and subject assessment, as this provides the basis for our marketing claims of the duration of effect. We look forward to continuing to set new standards in aesthetics and creating a new category of long-lasting peptide-enhanced neuromodulators.”
Remarkably, DAXXIFY™ was able to demonstrate a long duration of action using only 0.18 ng of the main active ingredient in the indication of 40 units for glabellar lines. With today’s approval, I look forward to helping patients who were used to a 3- to 4-month profile with conventional neuromodulators achieve year-round results with just two treatments per year.
DAXXIFY™ in West Palm Beach Gardens, Florida, approval in the U.S. was based on data from the SAKURA Phase 3 clinical trial program (SAKURA 1,2,3), which included more than 2,700 patients and approximately 4,200 treatments. In key exams:
Some patients maintained treatment results after nine months.
Results are visible as early as one day after treatment, and the best results will show in 14 days.
DAXXIFY™ is generally safe and well tolerated, with no treatment-related severe adverse events reported in clinical trials and a safety profile consistent with other neuromodulators currently available on the aesthetic market.
The most common treatment-related adverse events in DAXXIFY™ observed in pivotal studies were headache (6%) followed by eyelid ptosis (2%) and facial paresis, including facial asymmetry. These results are consistent with the same side effects seen with other neurotoxins, and it is no different than Botox, Dysport, or Xeomin. It is essential to mention that most side effects are rare, transitory, and treatable.
DAXXIFY™ will be available through elite Revance Aesthetics partners known for delivering exceptional consumer results and experiences. Beverly Hills Wellness Center and Med Spa in West Palm Beach Gardens, Florida, is one of the centers Ravence picked.
The company’s studies have shown that treatment lasts six months for half of the users, marking the first significant advance in facial injections in decades.
Eighty percent of people who were given the treatment, which was injected into the face along the lines of concern, saw no or only mild wrinkles after four months.
The Food and Drug Administration approved a new drug that reduced the appearance of facial wrinkles for about six months, fueling competition in a market dominated by Botox for decades.
Revance Therapeutics, the maker of the new treatment, Daxxify, announced the approval on September 8th, 2022, saying its effects — injected into the face along the lines of concern — lasted longer than other products on the market.
Like AbbVie’s botox in West Palm Beach Garden, Florida, the new treatment is a neuromuscular blocker that freezes away wrinkles. It is also botulinum toxin, which is not detected in the patient’s bloodstream when used as directed.
In studies submitted to the F.D.A., the treatment far exceeded the placebo effect, with about 80 percent of treatment providers seeing no or mild facial wrinkles four months after the injection and about half seeing an impact within six months.
Dr. Balaji Prasad, who covers specialty pharmaceuticals as an analyst, said the drug was the most significant advance in the facial injectables field since Botox – which now dominates 70 percent of the market.
“Users don’t have to go once every three months,” said Dr. Dahabra. “In a world where time is of the essence, having a long-lasting product is extremely useful.”
Mark Foley, C.E.O. of Revance Therapeutics, said in an interview on September 8th,2022, that the company spent many years trying to discover an effective neuromuscular blocker that could be applied to the skin without a needle. He found a way to stabilize the formula using peptide technology instead of the commonly used animal protein or human serum. That led to the approval of the product, which he said the company had already begun testing for various health concerns.
“It also opens the door to what we can do with therapeutics,” Mr. Foley said. “If you think about migraines, cervical dystonia, overactive bladder, there’s also a substantial medical opportunity.
One of the Revance studies submitted to the F.D.A. for the aesthetic use of Daxxify found that users experienced more side effects than those who received a placebo; six percent experienced a headache, and two percent developed a droopy eyelid. As we mentioned earlier, this is expected and consistent with other market neurotoxins.
F.D.A. warned of possible general muscle weakness or respiratory problems when using toxin-based treatments but said no such symptoms were seen with Daxxify in West Palm Beach Garden, Florida.
Book your treatment now to get this excellent new treatment and be wrinkle-free for a longer time.