The U.S. Food and Drug Administration (FDA) has approved BOTOX® Cosmetic (onabotulinumtoxinA) for the temporary improvement of moderate to severe platysma bands in adults. This new indication extends the product’s applications beyond the upper face to address vertical bands connecting the jaw and neck, making it the first neurotoxin to be approved for four distinct aesthetic indications: forehead lines, frown lines, crow’s feet, and now platysma bands.
Platysma bands, caused by the contraction of the thin platysma muscle in the neck, are a common concern among patients seeking aesthetic treatments. These bands can contribute to a less defined jawline and an aged appearance. BOTOX® Cosmetic works by temporarily reducing the activity of the platysma muscle, smoothing the appearance of the bands and enhancing the neck's overall appearance.
This new indication introduces a nonsurgical, minimally invasive treatment option for an area that has historically been difficult to address with injectables. The FDA-recommended doses range from 26 to 36 units, depending on the severity of the bands.
The FDA’s decision is supported by results from Phase III clinical trials. In these studies, patients treated with BOTOX® Cosmetic experienced significant improvement in the appearance of their platysma bands compared to those who received a placebo. The primary endpoint, based on both investigator and patient assessments, demonstrated statistical significance (p < 0.0001).
Additional secondary outcomes showed high levels of patient satisfaction. In two clinical studies, 65% and 62% of patients reported being “satisfied” or “very satisfied” with the appearance of their neck and jawline 14 days after treatment, compared to only 12% in the placebo groups.
This approval broadens the applications of neurotoxins in aesthetic treatments, offering healthcare professionals a new tool to address a wider range of patient concerns.
Healthcare providers seeking more information are encouraged to review product guidelines and clinical trial data on this indication.
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