The FDA recently approved a non-invasive cosmetic product that reduces wrinkles between the eyebrows. Daxxify The FDA approved Daxxify, an injection that improves the appearance of wrinkles, last week. The formula in Daxxify differs from the one in Botox because it does not use human blood.
Clinical trials on Daxxify indicated patients maintained results for a median time of 6 months. Move over Botox — the US just approved a new product to improve wrinkles. The Food and Drug Administration approved Daxxify, a cosmetic injection product similar to Botox, to smooth the appearance of frown lines on September 8.
Botox and its competitors use a formula called botulinum toxin A, which uses a neurotoxin to keep face muscles from forming wrinkles. Daxxify’s formula differs from Botox because it does not contain human blood or animal products. The new formula has produced longer-lasting results in patients, according to clinical trials performed by biotechnology company Revance.
(Allergan Aesthetics, the company that sells Botox, did not respond to Insider’s request for comment on this story. )Here’s everything you need to know about Daxxify. How is Daxxify different than Botox? Botox contains serum albumin, a protein found in human blood.
Dr. Jeffrey Dover, an an investigator from the Daxxify clinical trial and a former professor of dermatology at Harvard Medical School, told Insider serum albumin helps stabilize neurotoxins, or poison that alters the structure or function of nerve tissue. The small amount of neurotoxin in Botox temporarily blocks nerve impulses to facial muscles, weakening their movement and thus improving the appearance of wrinkles.
Daxxify does not use proteins from human blood to stabilize the neurotoxin. Daxxify uses a peptide, or small protein, that is highly charged and sticks to the toxin through an electrostatic force. Daxxify is the first Botox competitor in 30 years.
Why did it take so long?Market competitors to Botox use botulinum toxin A, but the amount of blood-derived protein varies. For instance Dysport, another cosmetic injection, is intended for people with moderate to severe frown lines. Daxxify’s non-blood containing formula is the first innovation of neurotoxin-containing injections to improve wrinkles in 30 years, according to Revance.
The peptide formula used for their technology is proprietary, meaning other companies were unable to experiment with it. Dr. Lawrence Green, a clinical professor of dermatology who was also an investigator on Daxxify clinical trials, said COVID-19 delayed the company’s filing by 6-8 months.
The FDA suspended all facility inspections in 2021, meaning Revance’s facility could not move forward with the product’s development and research. Trials suggest Daxxify’s effects last longer than BotoxBoth products reduce the appearance of fine lines through blocking nerve muscles with a neurotoxin. But, according to clinical trials, Daxxify provides results for longer.
Trial participants had their frown lines softened for a median of 6 months before needing another treatment. Some patients maintained the treatment for 9 months. Daxxify’s approval does not mean the end of Botox, Green said.
Some patients might prefer a shorter treatment in case they are dissatisfied with the results, and some providers might prefer Botox also to mitigate potential mishaps. “Usually [Daxxify] works really well, but people always think about the, ‘What if?'” Green said. “Which is important, I’m not saying that shouldn’t be thought of, but that’s the unusual rather than usual.
“Side effects include headaches and temporarily drooping eyelidsWhen Daxxify is injected between the eyebrows (as it was approved to be used by the FDA), “the side effect profile is very comparable to that of other botulinum toxin products on the market today,” Dover said. Those side effects are typically mild: headaches, and temporarily drooping eyelids or muscle stiffness. Cosmetic injections containing neurotoxins can cause rare but serious side effects including swelling from an allergic reaction, dry eye, irregular heartbeats and difficulty swallowing.
Green said he expects the FDA to approve Daxxify for other facial areas, but does not know when. The studies did not include as many men or people of colorPatients tested with Daxxify in phase 3 trials ranged between 21 to 86 years old. Dover said there was no difference in efficacy between younger, middle aged, and older women.
“This demonstrated that Daxxify will work equally well in younger individuals,” he added. However, the majority of trial participants were white and women, which Dover said is “very consistent” with other clinical trials for cosmetic products. Green said he does not expect men or people of color to experience different effects from Daxxify because Botox works the same across skin types.
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From: insider
URL: https://www.insider.com/how-is-daxxify-different-from-botox-2022-9
