Allergan Aesthetics 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. 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," says Darin J. Messina, Ph.D., senior vice president, Aesthetics R&D at Allergan Aesthetics. "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. 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 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. 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.