FDA approves Botox Cosmetic for platysma bands

Key takeaways:

• Botox Cosmetic temporarily decreases platysma muscle activity.
• It is the first product with four aesthetic indications: crow’s feet, forehead and frown lines and, now with this new approval, platysma bands.

The FDA has approved Botox Cosmetic to temporarily improve the appearance of moderate to severe platysma bands — vertical bands that connect the jaw and neck — in adults, according to a press release from the manufacturer.

With this approval, Botox Cosmetic (onabotulinumtoxinA, Allergan Aesthetics) is the first neurotoxin approved for platysma bands, as well as the first product of its kind to have four indications for aesthetics (platysma bands, crows’ feet, forehead and frown lines), the company said.

In phase 3 studies, Botox Cosmetic was associated with a significant improvement in platysma band appearance compared with placebo based on investigator and participant assessments, which served as the primary endpoint, according to the release. The treatment temporarily improves platysma band appearance by decreasing underlying muscle activity.

Botox Cosmetic also met secondary endpoints that were based on patient-reported outcomes. For example, the company said that most patients in two clinical trials (65% and 62%) reported they were either satisfied or very satisfied with their neck and jawline appearance 2 weeks after receiving 26, 31 or 36 units of Botox Cosmetic. In comparison, 12% of patients in each trial who received placebo reported these outcomes.

“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,” Terrence Keaney, MD, FAAD, a board-certified dermatologist at SkinDC and one of the clinical trial investigators, said in the release. “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.”

The prescribing information for Botox Cosmetic includes a boxed warning for “distant spread of toxin effect,” the release said. Postmarketing data show botulinum toxin products, including Botox Cosmetic, may spread from the injection area and cause symptoms such as asthenia, breathing issues, diplopia, dysarthria, dysphagia, dysphonia, generalized muscle weakness, ptosis and urinary incontinence.