On Sept. 7, 2022, the U.S. Food and Drug Administration (FDA) announced it had approved Revance Therapeutics’ DAXXIFY (daxibotulinumtoxin A) for use in adults to temporarily improve the appearance of moderate to severe glabellar lines (wrinkles between the eyebrows).

The FDA approved DAXXIFY based on evidence from two clinical trials (Studies GL-1 and GL-2), of 609 adult patients with moderate to severe glabellar lines (wrinkles between the eyebrows). The trials were conducted at 30 sites in the United States and Canada.

Botulinum toxin products may spread from the area of injection to other areas and cause serious life-threatening side effects including difficulty swallowing and difficulty breathing that could lead to death. Spread of botulinum toxin products to other areas can also cause loss of strength and muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, and loss of bladder control.

Other serious side effects of botulinum toxin products include severe allergic reactions and heart attack.

The most common side effects of DAXXIFY are headache, drooping eyelids, and weakness of facial muscles.