FDA OKs Botox for Forehead Lines, Its Third Facial Indication

Megan Brooks

October 03, 2017

The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (Botox Cosmetic, Allergan) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults, the company announced.

It marks the third indication for Botox Cosmetic for injection, which is already FDA approved to address moderate to severe lateral canthal lines (crow's feet) and moderate to severe glabellar lines (frown lines) in adults.  

Forehead lines are a "top area of concern" for patients, David Nicholson, Allergan's chief research and development officer, said in a news release. "Our goal in pursuing a third indication for Botox Cosmetic for the temporary improvement in the appearance of moderate to severe forehead lines was based on our desire to study the patient selection, dosing and injection pattern to help provide optimal treatment outcomes."

In clinical trials, Botox Cosmetic demonstrated efficacy compared with placebo in reducing the severity of forehead lines, as assessed by both the investigator and the patient at 30 days (primary endpoint).

Results showed that 61% of patients in study 1 and 46% of those in study 2 met the primary endpoint compared with placebo (0% in study 1 and 1% in study 2). Similar response rates were seen across three treatments cycles with Botox Cosmetic.

"As a physician, I've been using Botox Cosmetic since it was FDA approved in 2002, but for years my patients have also inquired about how to treat forehead lines. With this latest indication for Botox Cosmetic, I have an FDA-approved product I already know and trust, that can improve the appearance of the forehead," Steven Fagien, MD, an oculoplastic surgeon in Boca Raton, Florida, and lead clinical trial investigator, said in the release.

Botox Cosmetic has a boxed warning saying the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms consistent with botulinum toxin effects. Those symptoms include swallowing and breathing difficulties that can be life-threatening.

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