FDA Approves BOTOX® Cosmetic (OnabotulinumtoxinA) for the Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines Associated with Frontalis Muscle Activity In Adults

Published on October 11, 2017 by
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Allergan plc announced the FDA approval of BOTOX® Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the brand the first and only neurotoxin indicated for three facial treatment areas – forehead lines, crow’s feet lines and glabellar lines.

As the category leader, BOTOX® Cosmetic is also the only neurotoxin brand to receive approval of aesthetic indications beyond glabellar lines in the U.S.

“Allergan recognizes that forehead lines are a top area of concern for patients,” says David Nicholson, Chief Research and Development Officer at Allergan. “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.”

The BOTOX® Cosmetic story began in 2002 when the brand helped establish the aesthetic market with its first FDA approval to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines). The momentum continued in 2013 when BOTOX® Cosmetic was approved for the temporary improvement in the appearance of moderate to severe crow’s feet lines. The addition of this third indication furthers Allergan’s mission to continue providing patients and physicians with products designed to address specific patient needs.

“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,1” says Dr. Steven Fagien, an Oculoplastic Surgeon in Boca Raton, Floridaand lead clinical trial investigator. “I am proud to have worked closely with Allergan to establish criteria for proper patient selection, dosing and injection pattern for forehead line treatment and am pleased to see that the company is providing extensive injector training to help ensure optimal results.”

“Few products have the level of impact that BOTOX® Cosmetic has had on the medical facial aesthetics industry,” said David Moatazedi, Senior Vice President U.S. Medical Aesthetics at Allergan. “BOTOX®Cosmetic is the brand that created a new category in facial aesthetics with its first FDA approval 15 years ago.  Since then it has continued to be the leading neurotoxin treatment and the world’s number one selling product of its kind.”

In clinical trials, BOTOX® Cosmetic demonstrated efficacy compared with placebo in the reduction of the severity of forehead lines, as assessed by both the investigator and the subject at Day 30 (primary endpoint): 61% of subjects in study one and 46% of subjects in study two met the primary endpoint compared with placebo (0% in Study one and 1% in Study two). Similar response rates were seen across three treatments cycles with BOTOX®Cosmetic.