Masseter Botox Is One Step Closer to FDA Approval

Masseter Botox may be about to graduate from buzzy off-label favorite to official FDA-approved cosmetic treatment. The FDA has accepted AbbVie’s application seeking approval of Botox Cosmetic for the temporary improvement of masseter muscle prominence in adults, putting the treatment one step closer to an on-label indication.

And “widely requested” is not an exaggeration. NewBeauty has covered masseter Botox extensively, celebrities have spoken openly about getting it and the treatment has become increasingly familiar to anyone interested in facial sculpting. Patients often seek it for a slimmer-looking, more tapered lower face, though it is also commonly used off-label to help with clenching, teeth grinding and jaw tension.

A quick anatomy refresher: The masseter is the strong chewing muscle that runs from the cheekbone to the lower jaw. “Botox in the masseter essentially decreases masseter muscle contraction, which then causes masseter muscle to atrophy or shrink in size,” Clifton, NJ dermatologist Hee Jin Koh, MD, previously told NewBeauty. As that muscle gradually becomes smaller, the jawline can look softer, narrower and less square.

Of course, an accepted application is not the same thing as an approval. AbbVie’s submission is supported by a Phase 3, randomized, placebo-controlled trial in which a single 72-unit treatment improved the appearance of masseter muscle prominence and reduced lower-face width for up to six months. Researchers also reported an acceptable safety profile.

There is one important distinction to note: The proposed indication is strictly cosmetic. Even if approved, it would not cover jaw pain, clenching, teeth grinding or TMJ-related symptoms. Of course, that hasn’t stopped providers from using it off-label for those concerns—or patients from seeking it out. Masseter Botox has hardly been waiting for FDA approval to become popular; this would simply give one of beauty’s worst-kept secrets an official stamp.