BOTOX® Cosmetic Receives FDA Approval for Platysma Bands
Key Insights
BOTOX® Cosmetic (search) (onabotulinumtoxinA) gains FDA approval for temporarily improving the appearance of moderate to severe platysma bands (search) in adults.
This approval expands BOTOX® Cosmetic (search)'s indications, making it the first and only product approved for forehead lines, frown lines, crow's feet, and platysma bands (search).
Phase III trials showed statistically significant improvement in platysma band appearance with BOTOX® Cosmetic (search) compared to placebo (p<0.0001), based on investigator and subject assessments.
Allergan Aesthetics (search), an AbbVie (search) company, has announced that BOTOX® Cosmetic (search) (onabotulinumtoxinA) received FDA approval for the temporary improvement in the appearance of moderate to severe platysma bands (search) in adults. This approval marks the fourth aesthetic indication for BOTOX® Cosmetic, making it the first product of its kind to extend beyond facial treatments. The approval is based on Phase III clinical studies demonstrating statistically significant improvements in the appearance of platysma bands compared to placebo.
The platysma muscle, a thin layer covering the neck and lower face, can cause visible bands and a less defined jawline when contracted. BOTOX® Cosmetic (search) works by reducing the underlying muscle activity, thus improving the appearance of these bands. The treatment involves injections along the jawline and vertical bands of the neck, with doses of 26, 31, or 36 units based on severity.
Clinical Trial Results
Phase III clinical studies demonstrated a statistically significant improvement in the appearance of platysma bands (search) from baseline with BOTOX® Cosmetic (search) versus placebo (p<0.0001). This primary endpoint was based on both investigator and subject assessments. Secondary endpoints 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, compared to 12% in both studies with placebo.
Expert Commentary
Dr. Terrence Keaney, a board-certified dermatologist and clinical trial investigator, noted, "In my practice, the neck and lower face are always a standard part of my comprehensive aesthetic consultation. With the approval of BOTOX® Cosmetic (search) 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."
Safety Profile
The safety profile of BOTOX® Cosmetic (search) for platysma band treatment is consistent with its known safety profile for other indications. However, the FDA includes a boxed warning about the potential for distant spread of toxin effect. Common adverse reactions include eyelid ptosis, facial pain, facial paresis, and muscular weakness.
Additional Information
Patients interested in BOTOX® Cosmetic (search) for platysma bands (search) can enroll in Allē, Allergan Aesthetics (search)' loyalty rewards program. To learn more, visit www.botoxcosmetic.com.