The status of the new anti-wrinkle drug Daxxify was approved in the United States by the Food and Drug Administration (FDA) on Thursday, September 8, 2022. Following its FDA approval, Revance Therapeutics, the manufacturer of the drug, remains confident that it can provide stiff competition to Botox, a similar drug, which has dominated the medical field for more than 20 years.
DaxibotulinumtoxinA-lanm, marketed under the name Daxxify, is an injection which treats frown lines, or wrinkles, in adults. The drug provides temporary improvement to wrinkles and is also the first neuromodulator which has been stabilized using Peptide Exchange Technology or PXT. It does not have any human serum albumin or components that come from animals.
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According to its manufacturers, Daxxify can provide temporary treatment to wrinkles, ranging between moderate and serious, in adults in only six months, which is almost twice as long as that of Botox. Revance Therapeutics also revealed that the access to Daxxify will be expanded in the facial injectable market which is worth more than $3.2 billion.
The manufacturer has also said that their new facial drug is safe to use by adults and does not have any serious side effects. “(Daxxify) achieved clinically significant improvement with long-lasting results and high patient satisfaction,” a statement issued by the company read.
The clinical trials of Daxxify were conducted across 2,700 patients. 98% of the test subjects showed none or mild wrinkles four weeks after being injected with the drug. The effect of the drug remained for at least six months, while some experienced it for almost nine months.
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The new drug is a neuromuscular blocking agent and the FDA has said that like other similar drugs, its side effects could be witnessed in other areas of the human body. The primary side-effects of Daxxify have been headaches and eyelid ptosis, as documented in the clinical trials.
The price of Daxxify is yet to be made public by its manufacturers. However, the company has claimed that the new drug is the most advanced in its field in the previous 30 years. Meanwhile, the company has said that Daxxify will be released in the United States to high-volume injectors following a training program in Nashville.