FDA Approves Allergan Aesthetics’ Botox Cosmetic for Moderate to Severe Vertical Platysma Bands

Image Credit: Adobe Stock Images/Yakobchuk Olena

The FDA has approved Allergan Aesthetics’ Botox Cosmetic (onabotulinumtoxinA) to treat moderate to severe vertical platysma bands, marking its fourth approved aesthetic indication and the first beyond facial treatments. Allergan also stated that Botox offers a nonsurgical injectable option for improving the appearance of neck bands that can affect the jawline, addressing a major aesthetic concern for many adults.¹

"Research shows millions of consumers in the US are extremely or very bothered by their platysma bands. Until now, treatment options have been limited and with this approval, there is a nonsurgical, injectable option to temporarily improve the look of vertical bands connecting the jaw and neck," said Darin J. Messina, PhD, SVP, Aesthetics R&D, Allergan Aesthetics, in a press release. "This fourth indication for Botox Cosmetic represents true innovation. We're excited to open new doors for patients and providers, helping them to achieve their aesthetic goals."

The approval was based on results of Phase III clinical studies that demonstrated statistical significance for the improvement in appearance of platysma bands from baseline with Botox Cosmetic compared to placebo, meeting the primary endpoint. Additionally, 65% of patients expressed satisfaction with their neck and jawline definition two weeks post-treatment, while only 12% of participants in the placebo group of both studies reported the same. Survey answers were based on the appearance of their neck and jawline definition 14 days after treatment with a dose of 26, 31, or 36 units of Botox Cosmetic.

While there were no reports of serious adverse events (AEs) regarding distant spread of toxin effect associated with dermatologic use of Botox Cosmetic, Allergan warns that a number of serious AEs could occur due to unapproved use. These include excessive weakness, dysphagia, and aspiration pneumonia, with some AEs resulting in fatal outcomes.

Allergan also stated that AEs resulting from unapproved use are not necessarily related to distant spread of toxin but may have resulted from administration to the site of injection and/or adjacent structures. Additional AEs included hypersensitivity reactions such as anaphylaxis, serum sickness; urticaria; soft-tissue edema; and dyspnea; cardiovascular system issues; breathing difficulties; dry eyes; and increased risk for patients with preexisting neuromuscular disorders.¹

According to a study published in the National Library of Medicine, the platysma becomes thinner and less well defined with age. Additionally, medial fibers that previously decussated with fibers from the opposite side begin to separate. Platysmal bands begin to appear in most people by 55 years of age, getting worse over time. There are a number of theories as to how this happens, including skin laxity, loss of platysmal tone, and detachment of the platysma from deeper attachments. More recently, another theory suggests that the platysma becomes hyperkinetic, making the platysma more prominent.²

"In my practice, the neck and lower face are always a standard part of my comprehensive aesthetic consultation. Many of my patients are often surprised by the significant impact that changes in these areas can have," said Terrence Keaney, board-certified dermatologist, pivotal clinical trial investigator, in the press release. "With the approval of Botox Cosmetic for the treatment of platysma bands, including precise injection patterns and dosing, I can now confidently offer my patients a treatment option that can help deliver the results they are looking to achieve."

References

1. BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) AbbVie. October 18, 2024. Accessed October 21, 2024. https://news.abbvie.com/2024-10-18-BOTOX-R-Cosmetic-onabotulinumtoxinA-Receives-FDA-Approval-for-Moderate-to-Severe-Vertical-
Bands-Connecting-the-Jaw-and-Neck-Platysma-Bands

2. Anatomy, Head and Neck, Platysma. NIH. August 7, 2023. Accessed October 21, 2024. https://www.ncbi.nlm.nih.gov/books/NBK545294/#:~:text=Change%20in%20the%20platysma%20with,further%20laxity%20of%20neck%20structures.