FDA Approves Anti-Wrinkle Drug, Competitor to Botox

The US Food and Drug Administration (FDA) approved the new anti-wrinkle drug Daxxify. The drug developer says it offers a longer-lasting effect than other treatments on the market.

The FDA approved neuromodulator Daxxify (daxibotulinumtoixnA-lanm), developed by Revance Therapeutics Inc., to treat moderate-to-severe glabellar (frown) lines in adults. The drug is administered by an injection into the face.

The company says that in half of the clinical trial participants, the effect of the Daxxify injection lasted six months; in some — even nine months.

“DAXXIFY™ has the ability to address duration of treatment effect, which we believe is the greatest unmet need with existing neuromodulators for both consumers and injectors,” the company said in a statement.

Phase 3 clinical trial included more than 2,700 patients and approximately 4,200 treatments. The company says the results of Daxxify infection are seen as early as one day after treatment, but the effect typically appears within two days.

The drug was effective in most participants, as 98 percent of them had little or no appearance of wrinkles four weeks after injections.

The most common treatment-related adverse events were headache (6%), followed by eyelid ptosis (2%), and facial paresis, including facial asymmetry (1%).

Neuromodulators are usually injected directly into the underlying muscle, causing it to relax and gradually smooth out the appearance of the overlying skin, according to the American Society for Dermatologic Surgery (ASDS).

The effects of neuromodulators such as Botox Cosmetic, which has been dominating the market for years, typically last about three months.


FDA. Novel Drug Approvals for 2022.

Revance Therapeutics Inc. Revance Announces FDA Approval of DAXXIFY™ (DaxibotulinumtoxinA-lanm) for Injection, the First and Only Peptide-Formulated Neuromodulator With Long-Lasting Results.

American Society for Dermatologic Surgery. Neuromodulators for Wrinkles.

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