Global pharmaceutical company Allergan has announced that Botox Cosmetic (onabotulinumtoxinA) has been approved by the US Food and Drug Administration for its third indication.
The prescription-only medication has previously been approved for crow’s feet and glabella lines and is now approved for temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults.
"Allergan recognises 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," he added.
According to Allergan, in clinical trials, Botox Cosmetic was found to be more effective for reduction in the severity of forehead lines than placebo, and it has been described as safe in nearly 500 peer-reviewed articles in scientific and medical journals.
Dr Steven Fagien, an oculoplastic surgeon based in Boca Raton, Florida and lead clinical trial investigator, said, "I've been using Botox Cosmetic since it was FDA approved in 2002, but for years my patients have also enquired 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."