Will Platysma Prominence Be the Next Nod for BOTOX Cosmetic?

Allergan Aesthetics’ BOTOX Cosmetic met all primary and secondary endpoints for the treatment of moderate to severe platysma prominence associated with platysma muscle activity, according to topline results from the second of three Phase 3 studies.

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 adults with moderate to severe platysma prominence. The primary endpoint was met, demonstrating statistical significance for improvement with onabotulinumtoxinA versus placebo for the improvement in appearance of platysma prominence from baseline (based on both investigator and subject assessment). All secondary endpoints were met, as measured by multiple validated, proprietary patient-reported outcome (PRO) instruments assessing how bothered subjects are by the appearance of platysma prominence, psychosocial impact, treatment expectations and treatment satisfaction from the subject perspective.

Treatment-emergent adverse events for BOTOX Cosmetic were generally mild and consistent with known pharmacological effects of onabotulinumtoxinA and medical literature. Results were consistent with topline results from the first Phase 3 study (M21-309), announced in April 2023

"We are encouraged by these results, which demonstrated a significant reduction in the unwanted appearance of vertical band prominence on the neck and jawline," says Darin Messina, Ph.D., senior vice president, aesthetics R&D, AbbVie, in a news release.  "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."

"Platysma prominence occurs as part of the natural aging process and patients need non-invasive treatment options for the appearance of the lower face and neck and to help improve symmetry between the upper and lower face," adds Sachin Shridharani, MD, FACS, lead clinical investigator for the study. "Treatment with a proven neurotoxin may help relax the platysma muscle and thus reduce the appearance of vertical neck bands and improve jawline definition."

Additional study results will be submitted for presentation at future medical meetings. A Phase 3 open-label extension study is ongoing, with results expected later this year. Allergan Aesthetics will include data from the full Phase 3 study program as part of an upcoming U.S. Food and Drug Administration (FDA) regulatory submission expected near the end of the year.