Allergan Aesthetics, part of AbbVie, reports positive preliminary results from the second Phase 3 study on Botox Cosmetic’s, or onabotulinumtoxinA’s, effectiveness for treating prominent platysma muscle issues in the neck and lower face. This condition disrupts the neck and jawline aesthetics due to the contraction of the platysma muscle.
“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, PhD, 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 versus placebo in 426 adult subjects with moderate to severe platysma prominence. The primary endpoint was met, demonstrating statistical significance for improvement with onabotulinumtoxinA versus placebo (p<0.0001) for the improvement in appearance of platysma prominence from baseline (based on both investigator and subject assessment).
All secondary endpoints were achieved using validated tools that assessed patients’ concerns about platysma prominence appearance, its psychosocial effects, and their treatment expectations and satisfaction.
Adverse events from onabotulinumtoxinA were typically mild and in line with its known effects and medical literature. Its safety profile is well-known, with no new concerns observed, Allergan officials say. These results match those from the initial Phase 3 study announced in April 2023.
“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,” says Sachin Shridharani, MD, FACS, lead clinical investigator for the M21-310 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.”
Future medical meetings will present more study results. A Phase 3 study is underway, with findings due later this year. Allergan Aesthetics plans to submit this data to the U.S. FDA by year-end.