Allergan Aesthetics has announced that the U.S. Food and Drug Administration (FDA) has approved BOTOX® Cosmetic for temporary improvement in the appearance of moderate-to-severe vertical bands connecting the jaw and neck (platysma bands) in adults.
With this new approval, BOTOX® Cosmetic has now become the only product of its kind to be approved for the use of four aesthetic indications, temporary improvement in the appearance of moderate-to-severe forehead lines, frown lines, crow’s feet, and now platysma bands. Additionally, it is the first neurotoxin approved for platysma bands.
According to Darin J. Messina, Ph.D., Senior Vice President, Aesthetics R&D at Allergan Aesthetics, “Research shows millions of consumers in the U.S. are extremely or very bothered by their platysma bands. 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.”
In Phase III clinical trials, the primary endpoint was achieved, which showed a statistically significant improvement in the appearance of platysma bands from baseline with BOTOX® Cosmetic compared to placebo.
Secondary endpoints were also met. In two clinical studies, patient-reported outcomes revealed that most patients (65% and 62%) said they were “Very Satisfied” or “Satisfied” with the appearance of their neck and jawline definition 14 days after receiving treatment with a dose of 26, 31, or 36 units of BOTOX® Cosmetic. This is in comparison to only 12% with placebo in both studies.
Speaking of this latest news, Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator, states, “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. 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.”