Allergan has announced that Botox Cosmetic (onabotulinumtoxinA) has been approved for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults.
Botox Cosmetic – a prescription neurotoxin injection – is already approved for the temporary improvement of crow’s feet lines and frown lines between the eyebrows in adults.
Two clinical trials compared Botox Cosmetic to placebo for the improvement in appearance of moderate to severe forehead lines. The primary efficacy measure was the assessment of forehead line severity at maximum eyebrow elevation using the 4-point Facial Wrinkle Scale with Photonumeric Guide (0 to 3).
Results showed that 61% (n=290) in Study 1 and 46% (n=318) of patients in Study 1 and 2 met the primary efficacy endpoint at Day 30. The placebo group had 0% and 1% efficacy in Study 1 and 2, respectively.
Botox Cosmetic carries a Boxed Warning for the distant spread of toxin effect. Botulinum toxin may spread from the area of injection to produce symptoms that may include swallowing and breathing difficulties.
Botox Cosmetic is available as 50 Units of 100 Units strength powder in single-use vials for reconstitution.
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 [press release]. Dublin: PRNewswire. Updated October 3, 2017. Accessed October 20, 2017.
This article originally appeared on MPR