Vials of DAXXIFY (Photo: Business Wire) NASHVILLE, Tenn. - The U.S. Food and Drug Administration approved an injection designed to minimize the appearance of facial wrinkles, creating more competition in a market that has long been dominated by Botox. The anti-wrinkle injection, called Daxxify, was developed by manufacturer Revance Therapeutics, which announced the approval on Thursday.
Studies showed the drug can temporarily improve "moderate to severe frown lines" in adults for a median duration of six months, which is up to two months longer than the period generally provided by Botox.Botox received initial U.S. approval for therapeutic use in 1989 and was later studied and rebranded for the treatment of moderate to severe frown lines.
In 2002, the FDA approved it as a temporary cosmetic treatment for wrinkles — the first of its kind. The agency requested the AbbVie product be marketed as "BOTOX Cosmetic" to distinguish cosmetic from therapeutic uses, according to a product history. With the newly-approved product, Revance said Daxxify will expand its access to the growing $3.2 billion U.S.
facial injectables market.Like Botox, Daxxify is an acetylcholine release inhibitor and neuromuscular blocking agent. This means blocking certain chemical signals from nerves, mostly signals that cause muscles to contract, according to the Mayo Clinic. The most common use of Botox, and now Daxxify, is to temporarily relax the facial muscles that cause wrinkles.
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