Allergan Aesthetics, an AbbVie (NYSE: ABBV) company, today reported positive topline results from the second of three Phase 3 clinical studies evaluating onabotulinumtoxinA (Botox cosmetics) for the treatment of moderate to severe platysma prominence associated with platysma muscle activity (M21-310). Platysma prominence is an aesthetically unpleasant disruption to the neck, jawline, and lower face caused by platysma muscular contraction,1 a superficial, flat muscle in the lower face and neck.
The study compared the safety and efficacy of a single treatment of onabotulinumtoxinA (Botox cosmetics) with placebo in 426 adult individuals with moderate to severe platysma prominence in a multicenter, randomised, double-blind, placebo-controlled study.
Primary and Secondary Endpoints of M21-310 Study Evaluating Botox cosmetics:
The primary endpoint was met, with statistical significance for improvement in platysma prominent appearance with onabotulinumtoxinA (Botox cosmetics) versus placebo (p0.0001) (based on both investigator and patient assessment).
All secondary endpoints were met, according to multiple validated, proprietary patient-reported outcome (PRO) instruments that assess how bothered subjects are by the appearance of platysma prominence, psychosocial impact, treatment expectations, and treatment satisfaction from the subject’s perspective.
OnabotulinumtoxinA (Botox cosmetics) treatment-emergent side events were usually modest and compatible with recognised pharmacological effects of onabotulinumtoxinA and medical literature. The safety profile of onabotulinumtoxinA (Botox cosmetics) is well established, and no new safety signals were found.
The findings were similar with the topline findings of the first Phase 3 research (M21-309), which were reported in April 2023.
Expected Regulatory Submission for Botox cosmetics for platysma prominence:
Additional study findings will be presented at future medical events. A Phase 3 open-label extension study is in underway, with findings due later this year. Allergan Aesthetics will incorporate results from the whole Phase 3 trial programme in an upcoming FDA regulatory submission, which is due near the end of the year.
Expected US Filing
The company is expected to file for US approval by Q4 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,” 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.”
“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,” said 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.”
About Platysma Prominence:
The platysma muscle, a superficial, flat muscle in the lower face and neck that contributes to the creation of facial expressions, causes platysma prominence, an aesthetically unattractive disruption to the neck, jawline, and lower face.
In addition to vertical muscular bands, platysma muscle contraction can result in the creation of horizontal lines below the mandible and chin, blunting the jawline.
While platysma prominence is typically seen in older people, it can appear in younger patients as well. Surgical methods such as lower rhytidectomy (neck lift) and platysmaplasty are currently available as therapy alternatives.
Botox cosmetics (onabotulinumtoxinA):
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:
– Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
– Moderate to severe lateral canthal lines associated with orbicularis oculi activity
– Moderate to severe forehead lines associated with frontalis activity
