FDA Approves Botox Cosmetic for Platysma Bands, Expanding Aesthetic Applications
Key Insights
Botox Cosmetic receives FDA approval for improving the appearance of moderate to severe platysma bands (search) in adults, marking its fourth aesthetic indication.
Clinical trials demonstrated statistically significant improvements in platysma band appearance with Botox Cosmetic compared to placebo (p<0.0001).
The approval provides a non-surgical, injectable option for patients bothered by vertical bands connecting the jaw and neck, enhancing jawline definition.
Allergan Aesthetics (search), an AbbVie (search) company, has secured FDA approval for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck, commonly known as platysma bands (search), in adults. This approval marks the fourth aesthetic indication for Botox Cosmetic, which already includes treatments for forehead lines, frown lines, and crow's feet lines.
The approval is based on Phase III clinical studies that demonstrated statistically significant improvements in the appearance of platysma bands (search) with Botox Cosmetic compared to placebo (p<0.0001). The primary endpoint, a ≥ 2-grade improvement based on both investigator and subject assessments of platysma band severity at maximum contraction at day 14, was met in 32% of patients in one study and 31% in another, compared to 2% and 0% in the placebo groups, respectively.
Clinical Trial Outcomes
Secondary endpoints in the clinical trials were also met, as measured by patient-reported outcome (PRO) instruments. In two clinical studies, 65% and 62% of patients reported being "Very Satisfied" or "Satisfied" with the appearance of their neck and jawline definition 14 days after treatment with Botox Cosmetic, compared to 12% in both studies with placebo.
"With the approval of Botox Cosmetic for the treatment of platysma bands (search), 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," said Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator.
Addressing Patient Needs
The platysma muscle, a thin muscle covering the neck and lower face, can cause the appearance of bands on the neck and a less defined jawline when contracted. Botox Cosmetic works by temporarily reducing the underlying muscle activity, improving the appearance of these bands. The recommended doses range from 26 to 36 units, administered along the jawline and vertical bands, based on severity.
"Research shows millions of consumers in the U.S. are extremely or very bothered by their platysma bands (search)," said Darin J. Messina, Ph.D., Senior Vice President, Aesthetics R&D at Allergan Aesthetics (search). "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."
Safety Profile
The safety profile of Botox Cosmetic treatment of platysma bands (search) is consistent with the known safety profile of Botox Cosmetic for other indications. Common adverse reactions reported following injection of Botox Cosmetic include eyelid ptosis, facial pain, facial paresis, and muscular weakness.
Botox Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation. Caution should be exercised when administering to patients with preexisting cardiovascular disease or neuromuscular disorders.