FDA approves Botox Cosmetic for Moderate to Severe Platysma Bands

The Food and Drug Administration (FDA) has approved Botox Cosmetic (onabotulinumtoxinA) for temporary improvement of moderate to severe platysma bands associated with platysma muscle activity in adults.

BOTOX® Cosmetic is the first and only product with four aesthetic indication areas: forehead lines, frown lines, crow's feet lines, and now platysma bands, making it the first product of its kind to go beyond the face.

"Research shows millions of consumers in the U.S. 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, Ph.D., Senior Vice President, Aesthetics R&D at Allergan Aesthetics. "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 platysma muscle is a thin muscle that covers the neck and extends over the lower face. When this muscle is contracted it can cause the appearance of bands on the neck, which can also create a less defined jawline. Treatment with BOTOX® Cosmetic works beneath the surface to temporarily reduce the underlying muscle activity and improves the appearance of the bands connecting the neck and jaw. By injecting along the jawline and the vertical bands connecting the jaw and neck with one of the FDA-approved doses of BOTOX® Cosmetic based on severity-26, 31, or 36 units-BOTOX® Cosmetic temporarily reduces underlying muscle activity. Patients are encouraged to speak to their licensed aesthetic specialist to determine if treatment is right for them.

"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 Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator. "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."

In Phase III clinical studies, the primary endpoint was met, demonstrating statistical significance for the improvement in appearance of platysma bands from baseline with BOTOX® Cosmetic versus placebo (p<0.0001). This measure was based on both investigator and subject assessment. All secondary endpoints were met, as measured by multiple validated, proprietary patient-reported outcome (PRO) instruments.1 For example, in two clinical studies, a majority of patients (65% and 62%) reported being "Very Satisfied" or "Satisfied" (top two out of five responses) with the appearance of their neck and jawline definition 14 days after treatment with a dose of 26, 31, or 36 units of BOTOX® Cosmetic, compared to 12% in both studies with placebo.

Patients interested in learning more about BOTOX® Cosmetic for platysma bands are encouraged to enroll in Allē, the Allergan Aesthetics loyalty rewards program. In serving more than seven million Members across ~30,000 practices to date, part of Allē's mission is to help educate consumers about aesthetic treatments and to simplify office operations for practices. From its inception, Allē has disrupted the aesthetics industry by offering the most robust rewards program. Allē is the first and only loyalty program in the aesthetics market to also offer consumers the ability to earn points on over 50 non-Allergan Aesthetics treatments and brands. By providing Members with information, tools, and incentives, and now with flexible ways to pay through Allē Payment Plans powered by Cherry, Allē empowers consumers along their treatment journey, making the next product purchase or treatment closer within reach.

Nine million based on 2021 U.S. Census Projections: calculated from 2021 total population projections from a survey of 15,295 participants of which 3.8% indicated they were "Very" or "Extremely Bothered" (top two out of five responses) by their platysma bands.

Primary endpoint was a multi-component ≥ 2-grade improvement based on both Investigator and Subject assessments of Platysma Band Severity at maximum contraction at day 14: 32% (n=63) vs 2% placebo (n=4) in Study 1; 31% (n=64) vs 0% placebo (n=0) in Study 2.