The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines, Frown Lines, Crow’s Feet Lines, and Now Platysma Bands in Adults1-5
With this Approval, BOTOX® Cosmetic is the First and Only Aesthetic Neurotoxin Product to Temporarily Improve the Appearance of Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) in Adults1-5
IRVINE, Calif., Oct. 18, 2024 /PRNewswire/ — Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of BOTOX® Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults.1 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.1-5
“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 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.1 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.1 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