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–All primary and secondary endpoints were met for second Phase 3 study (M21-310) and results were consistent with findings from first Phase 3 study (M21-309).–Results support onabotulinumtoxinA as a potential treatment option for moderate to severe platysma prominence.–Data will be included as part of an upcoming U.S. Food and Drug Administration regulatory submission expected near the end of the year. If approved, onabotulinumtoxinA will be the first and only neurotoxin for this indication.
IRVINE, Calif., Sept. 18, 2023 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV), today announced positive topline results from the second of three Phase 3 clinical studies evaluating onabotulinumtoxinA (BOTOX® Cosmetic) for the treatment of moderate to severe platysma prominence associated with platysma muscle activity (M21-310). Platysma prominence is an aesthetically unappealing disruption to the neck, jawline and lower face that is attributed to contraction of the platysma muscle,1 a superficial, flat muscle in the lower face and neck.
"We are encouraged by these results, which demonstrated a significant reduction in the unwanted appearance of vertical band prominence on the neck and jawline," said Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie. "These results provide strong evidence in support of onabotulinumtoxinA as a potential treatment option for platysma prominence and once approved, will expand our neurotoxin portfolio into the lower face segment."
The multicenter, randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of a single treatment of onabotulinumtoxinA (BOTOX® Cosmetic) versus placebo in 426 adult subjects with moderate to severe platysma prominence. The primary endpoint was met, demonstrating statistical significance for improvement with onabotulinumtoxinA (BOTOX® Cosmetic) versus placebo (p
