BOTOX® Cosmetic Gets FDA Nod To Address Neck (Platysma) Bands

Allergan Aesthetics, part of AbbVie, announced that the U.S. FDA has approved BOTOX® Cosmetic to temporarily improve moderate-severe vertical bands connecting the jaw and neck in adults, known as platysma bands. This makes BOTOX® Cosmetic the first and only product approved for four aesthetic areas: forehead lines, frown lines, crow's feet, and platysma bands, making this a one-of-a-kind product.

Darin J. Messina, PhD, Senior Vice President, Aesthetics R&D at Allergan Aesthetics, commented, “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," also said, "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 is a thin muscle covering the neck and lower face, which, when contracted, can create bands and reduce jawline visibility. BOTOX® Cosmetic works by temporarily reducing muscle activity under the skin, improving the appearance of these bands. The treatment involves injecting BOTOX® Cosmetic along the jawline and vertical neck bands. Based on severity, FDA-approved doses are 26, 31, or 36 units. Patients are advised to consult with licensed aesthetic specialists to determine if the treatment is suitable 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. 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," said Dr. Terrence Keaney, board-certified dermatologist and pivotal clinical trial investigator.

Phase III clinical trials showed remarkable improvement in the appearance of platysma bands with BOTOX® Cosmetic compared to a placebo (p<0.0001), meeting the primary endpoint. Secondary endpoints were also met, with results based on investigator and patient assessments using multiple validated patient-reported outcome measures.