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The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox Cosmetic) for temporary improvement in the appearance of moderate to severe platysma bands in adults.
According to a press release from Allergan Aesthetics, which developed onabotulinumtoxinA, by injecting along the jawline and the vertical bands connecting the jaw and neck with one of the FDA-approved doses of the product based on severity, onabotulinumtoxinA temporarily reduces underlying muscle activity.
The company cited results from phase 3 clinical studies, which demonstrated statistical significance for the improvement in appearance of platysma bands from baseline with onabotulinumtoxinA compared with placebo on both investigator and patient assessment (P < .0001).
All secondary endpoints were also met, as measured by multiple validated, proprietary patient–reported outcome instruments. In two of the clinical studies, for example, 65% and 62% of patients reported being “very satisfied” or “satisfied,” respectively, with their neck and jawline definition 14 days after treatment with a dose of 26, 31, or 36 units of onabotulinumtoxinA compared with 12% with placebo in both studies.
The development marks the fourth indication for onabotulinumtoxinA. The others are for moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity, moderate to severe lateral canthal lines associated with orbicularis oculi activity, and moderate to severe forehead lines associated with frontalis activity.
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