Allergan's Botox Cosmetic now approved for treating platysma bands
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,
IRVINE: Allergan Aesthetics, part of AbbVie, recently announced that the U.S. FDA has approved BOTOX Cosmetic for temporarily improving the appearance of moderate to severe vertical bands between the jaw and neck (platysma bands) in adults.
BOTOX Cosmetic is now the first and only product approved for four aesthetic treatment areas: forehead lines, frown lines, crow's feet, and platysma bands, marking its expansion beyond facial applications.
"Research shows millions of consumers in the U.S. are extremely or very bothered by their platysma bands.6* 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 is a thin muscle that stretches across the neck and lower face. When contracted, it can create visible neck bands and a less defined jawline. BOTOX Cosmetic treatment targets this muscle beneath the skin, temporarily reducing its activity to improve the appearance of the neck and jaw bands. Injections are administered along the jawline and vertical bands with one of the FDA-approved doses—26, 31, or 36 units—depending on the severity. Patients should consult a licensed aesthetic specialist to determine if this treatment is suitable 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."
Phase III clinical trials demonstrated a significant improvement in the appearance of platysma bands with BOTOX® Cosmetic compared to placebo (p<0.0001), meeting the primary endpoint. This was assessed by both investigators and participants. All secondary endpoints were also achieved, as measured by several validated patient-reported outcome (PRO) tools. In two studies, 65% and 62% of patients reported being "Very Satisfied" or "Satisfied" with their neck and jawline appearance 14 days after receiving 26, 31, or 36 units of BOTOX Cosmetic, compared to only 12% with placebo.
Patients interested in BOTOX Cosmetic for platysma bands are encouraged to join Alle, the loyalty program from Allergan Aesthetics. Serving over seven million members across nearly 30,000 practices, Alle aims to educate consumers on aesthetic treatments and enhance practice operations. It offers a comprehensive rewards program, allowing members to earn points on over 50 treatments and brands, even beyond Allergan Aesthetics. Alle also offers flexible payment options through Alle Payment Plans, powered by Cherry, making aesthetic treatments more accessible.
According to 2021 U.S. Census estimates, about 3.8% of respondents in a survey of 15,295 participants were "Very" or "Extremely Bothered" by their platysma bands, equating to nine million individuals. In clinical trials, a ≥2-grade improvement in platysma band severity was observed in 32% of patients with BOTOX Cosmetic compared to 2% with placebo in Study 1, and 31% versus 0% in Study 2, based on assessments at day 14.
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